Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

This study has been completed.

Study NCT00819091 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on January 7, 2009. Last Updated on July 1, 2011 History of Changes

Results First Received: May 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: BI 1356 Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Matching placebo tablet taken orally once daily
Linagliptin (BI 1356) 5.0 mg	Linagliptin 5.0 mg tablet taken orally once daily

Participant Flow: Overall Study

	Placebo	Linagliptin (BI 1356) 5.0 mg
STARTED	84	161
COMPLETED	77	151
NOT COMPLETED	7	10
Adverse Event	3	5
Protocol Violation	0	1
Lost to Follow-up	2	0
Withdrawal by Subject	1	2
Not Specified	1	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Matching placebo tablet taken orally once daily
Linagliptin 5.0 mg	Linagliptin 5.0 mg tablet taken orally once daily

Baseline Measures

	Placebo	Linagliptin 5.0 mg	Total
Number of Participants [units: participants]	84	161	245
Age [units: years] Mean ± Standard Deviation	56.2 ± 10.2	57.2 ± 9.8	56.9 ± 9.9
Gender [units: participants]
Female	32	84	116
Male	52	77	129
Race/Ethnicity, Customized [units: participants]
White	34	73	107
Black	6	11	17
Asian	43	76	119
American Indian/Alaskan Native	1	1	2
Race/Ethnicity, Customized [units: participants]
Not Hispanic	70	133	203
Hispanic	14	28	42
Body Mass Index (BMI) [units: kilogram/square meter] Mean ± Standard Deviation	28.21 ± 5.12	28.40 ± 5.02	28.33 ± 5.04
Baseline glycosylated hemoglobin (HbA1c) [units: percentage] Mean ± Standard Deviation	8.6 ± 0.72	8.61 ± 0.85	8.61 ± 0.81
Fasting blood plasma glucose (FPG) [units: milligram/deciliter (mg/dL)] Mean ± Standard Deviation	174.9 ± 49.0	182.0 ± 51.8	179.6 ± 50.9

Outcome Measures

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1. Primary:

Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 [ Time Frame: Baseline, week 18 ]

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2. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 18 [ Time Frame: Baseline, week 18 ]

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3. Secondary:

Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 [ Time Frame: week 18 ]

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4. Secondary:

Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 [ Time Frame: week 18 ]

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5. Secondary:

Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 [ Time Frame: Baseline, week 18 ]

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6. Secondary:

Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 [ Time Frame: Baseline, week 6 ]

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7. Secondary:

Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline, week 12 ]

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8. Secondary:

Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 [ Time Frame: Baseline, week 18 ]

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9. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 6 [ Time Frame: Baseline, week 6 ]

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10. Secondary:

Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline, week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00819091 History of Changes
Other Study ID Numbers:	1218.35, 2008-003118-86
Study First Received:	January 7, 2009
Results First Received:	May 13, 2011
Last Updated:	July 1, 2011
Health Authority:	Argentina: ANMAT (Food, Drug and Medical Technology National Administration); Hungary: National Institute of Pharmacy; India: Drugs Controller General India; Japan: Ministry of Health, Labor and Welfare; Poland:; Russia: Pharmacological Committee, Ministry of Health; United States: Food and Drug Administration