Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT00954447
• Recruitment Status: Completed
• First Posted: August 7, 2009
• Results First Posted: September 27, 2012
• Last Update Posted: December 30, 2013
• Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Boehringer Ingelheim

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Linagliptin
• Enrollment: 1263

Participant Flow

Recruitment Details
Pre-assignment Details	Randomised, double-blind, placebo-controlled, parallel group study. Whilst 1263 were randomised, only 1261 were treated.

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Period Title: Overall Study
Started	630	631
Completed	520	543
Not Completed	110	88
Reason Not Completed
Adverse Event	33	25
Lack of Efficacy	17	3
Protocol Violation	5	7
Lost to Follow-up	8	14
Withdrawal by Subject	26	21
Other	21	18

Baseline Characteristics

Arm/Group Title		Placebo	Linagliptin 5 mg	Total
Arm/Group Description		Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Total of all reporting groups
Overall Number of Baseline Participants		630	631	1261
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	630 participants	631 participants	1261 participants
		60.4 (10.0)	59.7 (9.9)	60.0 (10.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	630 participants	631 participants	1261 participants
	Female	301 47.8%	302 47.9%	603 47.8%
	Male	329 52.2%	329 52.1%	658 52.2%
Baseline HbA1c [1]; Mean (Standard Deviation); Unit of measure: Percentage
	Number Analyzed	630 participants	631 participants	1261 participants
		8.29 (0.85)	8.31 (0.85)	8.30 (0.85)
		[1] Measure Description: Baseline HbA1c was defined as the last available HbA1c measurement prior to the start of randomised study treatment.There were 617 patients with non-missing baseline HbA1c in Placebo group and 618 patients with non-missing values in Linagliptin 5 mg.

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in HbA1c After 24 Weeks
Description	HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.07 (0.08)	-0.58 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.65
	Confidence Interval	95%; -0.74 to -0.55
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	Linagliptin 5mg - Placebo

2. Secondary Outcome

Title	Number of Patients With HbA1c < 7.0 Percent
Description	[Not Specified]
Time Frame	24 and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Measure Type: Number; Unit of Measure: Participants
after 24 weeks of treatment	56	134
after 52 weeks of treatment	44	109

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	FAS with baseline HbA1c >= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression of HbA1c < 7.0 percent at week 52
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.935
	Confidence Interval	95%; 1.949 to 4.419
	Estimation Comments	Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment

3. Secondary Outcome

Title	Number of Patients Lowering HbA1c by at Least 0.5 Percent
Description	[Not Specified]
Time Frame	24 and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS (NCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Measure Type: Number; Unit of Measure: Participants
after 24 weeks of treatment	137	333
after 52 weeks of treatment	104	231

4. Secondary Outcome

Title	Change From Baseline in HbA1c by Visit at Week 6
Description	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 6 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.00 (0.05)	-0.45 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.45
	Confidence Interval	95%; -0.51 to -0.39
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.03
	Estimation Comments	Linagliptin 5mg - Placebo

5. Secondary Outcome

Title	Change From Baseline in HbA1c by Visit at Week 12
Description	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.02 (0.07)	-0.59 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.61
	Confidence Interval	95%; -0.69 to -0.52
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.04
	Estimation Comments	Linagliptin 5mg - Placebo

6. Secondary Outcome

Title	Change From Baseline in HbA1c by Visit at Week 18
Description	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 18 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.03 (0.08)	-0.64 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.67
	Confidence Interval	95%; -0.76 to -0.57
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	Linagliptin 5mg - Placebo

7. Secondary Outcome

Title	Change From Baseline in HbA1c by Visit at Week 32
Description	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 32 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.01 (0.08)	-0.56 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.57
	Confidence Interval	95%; -0.67 to -0.47
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	Linagliptin 5mg - Placebo

8. Secondary Outcome

Title	Change From Baseline in HbA1c by Visit at Week 40
Description	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 40 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.05 (0.08)	-0.50 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.55
	Confidence Interval	95%; -0.65 to -0.45
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	Linagliptin 5mg - Placebo

9. Secondary Outcome

Title	Change From Baseline in HbA1c by Visit at Week 52
Description	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: Percentage
	0.05 (0.08)	-0.48 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.53
	Confidence Interval	95%; -0.64 to -0.43
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.05
	Estimation Comments	Linagliptin 5mg - Placebo

10. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment
Description	Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	609	614
Mean (Standard Error); Unit of Measure: mg/dL
	4.52 (3.94)	-7.09 (3.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.60
	Confidence Interval	95%; -16.49 to -6.71
	Parameter Dispersion	Type: Standard Error of the mean; Value: 2.49
	Estimation Comments	Linagliptin 5mg - Placebo

11. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Description	[Not Specified]
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	609	614
Mean (Standard Deviation); Unit of Measure: mg/dL
	0.63 (56.44)	-2.55 (55.01)

12. Secondary Outcome

Title	Change From Baseline in FPG
Description	[Not Specified]
Time Frame	Baseline, 6, 12, 18, 24, 32 and 40 weeks

Outcome Measure Data

Analysis Population Description

FAS, observed cases (OC)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	600	606
Mean (Standard Deviation); Unit of Measure: mg/dL
after 6 weeks of treatment	2.97 (50.89)	-5.29 (44.74)
after 12 weeks of treatment (N=556, N=590)	-0.33 (51.09)	-7.59 (48.50)
after 18 weeks of treatment (N=533, N=567)	2.10 (53.21)	-3.30 (55.51)
after 24 weeks of treatment (N=499, N=533)	0.04 (54.94)	-7.07 (44.70)
after 32 weeks of treatment (N=436, N=491)	-2.67 (52.43)	-6.30 (48.16)
after 40 weeks of treatment (N=357, N=429)	-3.99 (50.29)	-6.50 (50.00)

13. Secondary Outcome

Title	Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment
Description	Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS (LOCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Mean (Standard Error); Unit of Measure: International units (IU)
	4.18 (0.84)	2.60 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0029
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.58
	Confidence Interval	95%; -2.61 to -0.54
	Parameter Dispersion	Type: Standard Error of the mean; Value: 0.53
	Estimation Comments	Linagliptin 5mg - Placebo

14. Secondary Outcome

Title	Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
Description	Mean Daily Glucose was calculated using the 8-point blood glucose profile
Time Frame	Baseline, 24 and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS (OC)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	55	52
Mean (Standard Deviation); Unit of Measure: mmol*hr/L
after 24 weeks of treatment	0.03 (2.28)	-0.01 (1.98)
after 52 weeks of treatment (N=25, N=15)	0.10 (3.06)	-0.50 (2.35)

15. Secondary Outcome

Title	Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
Description	[Not Specified]
Time Frame	Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner

Outcome Measure Data

Analysis Population Description

FAS (OC)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	60	61
Mean (Standard Deviation); Unit of Measure: mmol*hr/L
post-breakfast incremental glucose	9.31 (44.02)	-3.78 (63.63)
post-lunch incremental glucose (N=34, N=41)	-17.80 (61.94)	-11.00 (68.04)
post-dinner incremental glucose (N=46, N=57)	-1.71 (68.15)	-3.26 (66.51)

16. Other Pre-specified Outcome

Title	Number of Patients With HbA1c < 6.5 Percent
Description	[Not Specified]
Time Frame	24 and 52 weeks

Outcome Measure Data

Analysis Population Description

FAS (NCF)

Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description:	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed	617	618
Measure Type: Number; Unit of Measure: Participants
after 24 weeks of treatment	10	50
after 52 weeks of treatment	12	46

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Linagliptin 5 mg
	Comments	FAS with baseline HbA1c >= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression of HbA1c < 6.5 percent at week 52
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.327
	Confidence Interval	95%; 2.221 to 8.430
	Estimation Comments	Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment

Adverse Events

Time Frame	52 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo	Linagliptin 5 mg
Arm/Group Description	Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.	Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
All-Cause Mortality
	Placebo	Linagliptin 5 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Placebo	Linagliptin 5 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	83/630 (13.17%)	87/631 (13.79%)
Blood and lymphatic system disorders
Anaemia † 1	1/630 (0.16%)	0/631 (0.00%)
Iron deficiency anaemia † 1	1/630 (0.16%)	0/631 (0.00%)
Pancytopenia † 1	1/630 (0.16%)	0/631 (0.00%)
Cardiac disorders
Acute coronary syndrome † 1	1/630 (0.16%)	1/631 (0.16%)
Acute myocardial infarction † 1	0/630 (0.00%)	2/631 (0.32%)
Angina pectoris † 1	1/630 (0.16%)	2/631 (0.32%)
Angina unstable † 1	1/630 (0.16%)	3/631 (0.48%)
Arteriosclerosis coronary artery † 1	1/630 (0.16%)	1/631 (0.16%)
Atrial fibrillation † 1	1/630 (0.16%)	1/631 (0.16%)
Cardiac failure † 1	2/630 (0.32%)	3/631 (0.48%)
Cardiac failure congestive † 1	2/630 (0.32%)	1/631 (0.16%)
Cardiogenic shock † 1	0/630 (0.00%)	1/631 (0.16%)
Coronary artery disease † 1	3/630 (0.48%)	2/631 (0.32%)
Coronary artery occlusion † 1	1/630 (0.16%)	1/631 (0.16%)
Coronary artery stenosis † 1	1/630 (0.16%)	1/631 (0.16%)
Myocardial infarction † 1	1/630 (0.16%)	1/631 (0.16%)
Myocardial ischaemia † 1	2/630 (0.32%)	1/631 (0.16%)
Silent myocardial infarction † 1	0/630 (0.00%)	1/631 (0.16%)
Sinus tachycardia † 1	1/630 (0.16%)	0/631 (0.00%)
Endocrine disorders
Hyperthyroidism † 1	0/630 (0.00%)	1/631 (0.16%)
Eye disorders
Cataract † 1	0/630 (0.00%)	2/631 (0.32%)
Diplopia † 1	1/630 (0.16%)	1/631 (0.16%)
Retinal detachment † 1	1/630 (0.16%)	0/631 (0.00%)
Retinopathy proliferative † 1	1/630 (0.16%)	0/631 (0.00%)
Vitreous adhesions † 1	0/630 (0.00%)	1/631 (0.16%)
Vitreous haemorrhage † 1	0/630 (0.00%)	1/631 (0.16%)
Gastrointestinal disorders
Abdominal hernia † 1	1/630 (0.16%)	0/631 (0.00%)
Abdominal pain † 1	0/630 (0.00%)	1/631 (0.16%)
Abdominal pain lower † 1	1/630 (0.16%)	0/631 (0.00%)
Diverticulum intestinal haemorrhagic † 1	1/630 (0.16%)	1/631 (0.16%)
Duodenal ulcer † 1	0/630 (0.00%)	1/631 (0.16%)
Gastric ulcer † 1	1/630 (0.16%)	2/631 (0.32%)
Gastritis erosive † 1	0/630 (0.00%)	1/631 (0.16%)
Mallory-Weiss syndrome † 1	0/630 (0.00%)	1/631 (0.16%)
Megacolon † 1	0/630 (0.00%)	1/631 (0.16%)
Nausea † 1	1/630 (0.16%)	0/631 (0.00%)
Oesophageal varices haemorrhage † 1	0/630 (0.00%)	1/631 (0.16%)
Pancreatitis † 1	1/630 (0.16%)	1/631 (0.16%)
Pancreatitis chronic † 1	0/630 (0.00%)	1/631 (0.16%)
Umbilical hernia † 1	1/630 (0.16%)	0/631 (0.00%)
Upper gastrointestinal haemorrhage † 1	0/630 (0.00%)	1/631 (0.16%)
Vomiting † 1	1/630 (0.16%)	1/631 (0.16%)
General disorders
Chest pain † 1	1/630 (0.16%)	1/631 (0.16%)
Death † 1	1/630 (0.16%)	0/631 (0.00%)
Non-cardiac chest pain † 1	1/630 (0.16%)	0/631 (0.00%)
Pyrexia † 1	1/630 (0.16%)	0/631 (0.00%)
Sudden death † 1	0/630 (0.00%)	2/631 (0.32%)
Hepatobiliary disorders
Cholecystitis acute † 1	1/630 (0.16%)	1/631 (0.16%)
Cholelithiasis † 1	0/630 (0.00%)	1/631 (0.16%)
Hepatic cyst † 1	0/630 (0.00%)	1/631 (0.16%)
Infections and infestations
Appendicitis perforated † 1	1/630 (0.16%)	0/631 (0.00%)
Beta haemolytic streptococcal infection † 1	1/630 (0.16%)	0/631 (0.00%)
Bronchitis † 1	0/630 (0.00%)	2/631 (0.32%)
Bronchopneumonia † 1	1/630 (0.16%)	0/631 (0.00%)
Cellulitis † 1	1/630 (0.16%)	0/631 (0.00%)
Cellulitis of male external genital organ † 1	1/630 (0.16%)	0/631 (0.00%)
Clostridium difficile colitis † 1	1/630 (0.16%)	0/631 (0.00%)
Erysipelas † 1	2/630 (0.32%)	1/631 (0.16%)
Gangrene † 1	1/630 (0.16%)	0/631 (0.00%)
Gastroenteritis † 1	2/630 (0.32%)	2/631 (0.32%)
Infected skin ulcer † 1	0/630 (0.00%)	1/631 (0.16%)
Influenza † 1	1/630 (0.16%)	0/631 (0.00%)
Localised infection † 1	0/630 (0.00%)	1/631 (0.16%)
Meningitis streptococcal † 1	1/630 (0.16%)	0/631 (0.00%)
Orchitis † 1	1/630 (0.16%)	0/631 (0.00%)
Osteomyelitis † 1	1/630 (0.16%)	0/631 (0.00%)
Pneumonia † 1	4/630 (0.63%)	3/631 (0.48%)
Pneumonia staphylococcal † 1	0/630 (0.00%)	1/631 (0.16%)
Staphylococcal infection † 1	0/630 (0.00%)	1/631 (0.16%)
Streptococcal infection † 1	0/630 (0.00%)	1/631 (0.16%)
Upper respiratory tract infection † 1	0/630 (0.00%)	1/631 (0.16%)
Urinary tract infection † 1	2/630 (0.32%)	1/631 (0.16%)
Urosepsis † 1	1/630 (0.16%)	0/631 (0.00%)
Injury, poisoning and procedural complications
Alcohol poisoning † 1	0/630 (0.00%)	1/631 (0.16%)
Ankle fracture † 1	2/630 (0.32%)	0/631 (0.00%)
Contusion † 1	0/630 (0.00%)	2/631 (0.32%)
Electric shock † 1	0/630 (0.00%)	1/631 (0.16%)
Excoriation † 1	0/630 (0.00%)	1/631 (0.16%)
Fall † 1	4/630 (0.63%)	3/631 (0.48%)
Fibula fracture † 1	0/630 (0.00%)	1/631 (0.16%)
Fractured ischium † 1	0/630 (0.00%)	1/631 (0.16%)
Head injury † 1	1/630 (0.16%)	0/631 (0.00%)
Joint sprain † 1	0/630 (0.00%)	1/631 (0.16%)
Laceration † 1	1/630 (0.16%)	0/631 (0.00%)
Ligament injury † 1	0/630 (0.00%)	1/631 (0.16%)
Lower limb fracture † 1	0/630 (0.00%)	1/631 (0.16%)
Meniscus lesion † 1	1/630 (0.16%)	0/631 (0.00%)
Muscle injury † 1	1/630 (0.16%)	1/631 (0.16%)
Muscle rupture † 1	0/630 (0.00%)	1/631 (0.16%)
Muscle strain † 1	1/630 (0.16%)	0/631 (0.00%)
Pelvic fracture † 1	0/630 (0.00%)	1/631 (0.16%)
Road traffic accident † 1	1/630 (0.16%)	2/631 (0.32%)
Scapula fracture † 1	1/630 (0.16%)	0/631 (0.00%)
Subdural haematoma † 1	1/630 (0.16%)	2/631 (0.32%)
Tendon rupture † 1	1/630 (0.16%)	0/631 (0.00%)
Tibia fracture † 1	1/630 (0.16%)	1/631 (0.16%)
Toxicity to various agents † 1	0/630 (0.00%)	1/631 (0.16%)
Wrist fracture † 1	1/630 (0.16%)	1/631 (0.16%)
Investigations
Blood creatine phosphokinase increased † 1	0/630 (0.00%)	1/631 (0.16%)
Colonoscopy † 1	0/630 (0.00%)	1/631 (0.16%)
Metabolism and nutrition disorders
Dehydration † 1	0/630 (0.00%)	1/631 (0.16%)
Diabetes mellitus † 1	1/630 (0.16%)	0/631 (0.00%)
Hyperglycaemia † 1	2/630 (0.32%)	0/631 (0.00%)
Hypoglycaemia † 1	1/630 (0.16%)	3/631 (0.48%)
Musculoskeletal and connective tissue disorders
Back pain † 1	0/630 (0.00%)	1/631 (0.16%)
Flank pain † 1	0/630 (0.00%)	1/631 (0.16%)
Musculoskeletal chest pain † 1	1/630 (0.16%)	0/631 (0.00%)
Musculoskeletal pain † 1	1/630 (0.16%)	0/631 (0.00%)
Neck pain † 1	0/630 (0.00%)	1/631 (0.16%)
Osteoarthritis † 1	3/630 (0.48%)	2/631 (0.32%)
Osteolysis † 1	1/630 (0.16%)	0/631 (0.00%)
Spinal column stenosis † 1	1/630 (0.16%)	0/631 (0.00%)
Tendonitis † 1	0/630 (0.00%)	1/631 (0.16%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer † 1	0/630 (0.00%)	1/631 (0.16%)
Colon cancer † 1	0/630 (0.00%)	1/631 (0.16%)
Gastric cancer † 1	0/630 (0.00%)	1/631 (0.16%)
Hepatic neoplasm malignant † 1	1/630 (0.16%)	0/631 (0.00%)
Leiomyosarcoma metastatic † 1	1/630 (0.16%)	0/631 (0.00%)
Lung adenocarcinoma † 1	1/630 (0.16%)	1/631 (0.16%)
Non-small cell lung cancer metastatic † 1	2/630 (0.32%)	0/631 (0.00%)
Ovarian adenoma † 1	1/630 (0.16%)	2/631 (0.32%)
Renal cancer † 1	1/630 (0.16%)	0/631 (0.00%)
Squamous cell carcinoma † 1	0/630 (0.00%)	1/631 (0.16%)
Uterine cancer † 1	0/630 (0.00%)	1/631 (0.16%)
Uterine leiomyoma † 1	0/630 (0.00%)	1/631 (0.16%)
Nervous system disorders
Cerebrovascular accident † 1	0/630 (0.00%)	2/631 (0.32%)
Cerebrovascular disorder † 1	1/630 (0.16%)	0/631 (0.00%)
Cranial nerve paralysis † 1	0/630 (0.00%)	1/631 (0.16%)
Dizziness † 1	0/630 (0.00%)	1/631 (0.16%)
Embolic stroke † 1	1/630 (0.16%)	0/631 (0.00%)
Haemorrhagic stroke † 1	1/630 (0.16%)	1/631 (0.16%)
Ischaemic stroke † 1	2/630 (0.32%)	0/631 (0.00%)
Loss of consciousness † 1	0/630 (0.00%)	1/631 (0.16%)
Syncope † 1	1/630 (0.16%)	0/631 (0.00%)
Transient ischaemic attack † 1	0/630 (0.00%)	1/631 (0.16%)
Psychiatric disorders
Alcohol abuse † 1	1/630 (0.16%)	0/631 (0.00%)
Depression † 1	1/630 (0.16%)	0/631 (0.00%)
Mental disorder due to a general medical condition † 1	1/630 (0.16%)	0/631 (0.00%)
Suicide attempt † 1	0/630 (0.00%)	1/631 (0.16%)
Renal and urinary disorders
Calculus ureteric † 1	0/630 (0.00%)	1/631 (0.16%)
Glomerulonephritis † 1	1/630 (0.16%)	0/631 (0.00%)
Haematuria † 1	0/630 (0.00%)	1/631 (0.16%)
Hydronephrosis † 1	1/630 (0.16%)	0/631 (0.00%)
Nephrolithiasis † 1	0/630 (0.00%)	2/631 (0.32%)
Renal colic † 1	1/630 (0.16%)	1/631 (0.16%)
Renal failure acute † 1	3/630 (0.48%)	0/631 (0.00%)
Renal failure chronic † 1	1/630 (0.16%)	0/631 (0.00%)
Reproductive system and breast disorders
Benign prostatic hyperplasia † 1	1/630 (0.16%)	0/631 (0.00%)
Penile pain † 1	1/630 (0.16%)	0/631 (0.00%)
Prostatitis † 1	1/630 (0.16%)	0/631 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema † 1	1/630 (0.16%)	0/631 (0.00%)
Asthma † 1	1/630 (0.16%)	0/631 (0.00%)
Asthmatic crisis † 1	0/630 (0.00%)	1/631 (0.16%)
Atelectasis † 1	0/630 (0.00%)	1/631 (0.16%)
Chronic obstructive pulmonary disease † 1	1/630 (0.16%)	1/631 (0.16%)
Dyspnoea † 1	1/630 (0.16%)	0/631 (0.00%)
Nasal polyps † 1	1/630 (0.16%)	0/631 (0.00%)
Organising pneumonia † 1	1/630 (0.16%)	0/631 (0.00%)
Pulmonary embolism † 1	1/630 (0.16%)	0/631 (0.00%)
Pulmonary oedema † 1	1/630 (0.16%)	0/631 (0.00%)
Skin and subcutaneous tissue disorders
Skin ulcer † 1	0/630 (0.00%)	1/631 (0.16%)
Surgical and medical procedures
Ureteral catheterisation † 1	1/630 (0.16%)	0/631 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	0/630 (0.00%)	1/631 (0.16%)
Embolism † 1	0/630 (0.00%)	1/631 (0.16%)
Extremity necrosis † 1	0/630 (0.00%)	1/631 (0.16%)
Hypertensive crisis † 1	2/630 (0.32%)	0/631 (0.00%)
Hypotension † 1	1/630 (0.16%)	0/631 (0.00%)
Intermittent claudication † 1	1/630 (0.16%)	0/631 (0.00%)
Lymphoedema † 1	1/630 (0.16%)	0/631 (0.00%)
Peripheral ischaemia † 1	0/630 (0.00%)	1/631 (0.16%)
Venous thrombosis limb † 1	1/630 (0.16%)	0/631 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 14.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Linagliptin 5 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	354/630 (56.19%)	354/631 (56.10%)
Gastrointestinal disorders
Diarrhoea † 1	30/630 (4.76%)	33/631 (5.23%)
Infections and infestations
Influenza † 1	33/630 (5.24%)	26/631 (4.12%)
Nasopharyngitis † 1	62/630 (9.84%)	71/631 (11.25%)
Urinary tract infection † 1	43/630 (6.83%)	30/631 (4.75%)
Metabolism and nutrition disorders
Hyperglycaemia † 1	112/630 (17.78%)	90/631 (14.26%)
Hypoglycaemia † 1	197/630 (31.27%)	191/631 (30.27%)
Musculoskeletal and connective tissue disorders
Back pain † 1	30/630 (4.76%)	34/631 (5.39%)
Nervous system disorders
Dizziness † 1	30/630 (4.76%)	33/631 (5.23%)
Headache † 1	27/630 (4.29%)	35/631 (5.55%)
Vascular disorders
Hypertension † 1	35/630 (5.56%)	30/631 (4.75%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 14.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Results Point of Contact

• Name/Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals
• Phone: 1-800-243-0127
• EMail: clintriage.rdg@boehringer-ingelheim.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sheu WH, Park SW, Gong Y, Pinnetti S, Bhattacharya S, Patel S, Seck T, Woerle HJ. Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. Epub 2015 Feb 13.

Yki-Jarvinen H, Rosenstock J, Duran-Garcia S, Pinnetti S, Bhattacharya S, Thiemann S, Patel S, Woerle HJ. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a >/=52-week randomized, double-blind study. Diabetes Care. 2013 Dec;36(12):3875-81. doi: 10.2337/dc12-2718. Epub 2013 Sep 23.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT00954447
• Other Study ID Numbers: 1218.36; 2008-008296-33 ( EudraCT Number: EudraCT )
• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Results First Submitted: August 28, 2012
• Results First Posted: September 27, 2012
• Last Update Posted: December 30, 2013