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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00954447
First received: August 6, 2009
Last updated: December 4, 2013
Last verified: October 2012
Results First Received: August 28, 2012  
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: Placebo
Drug: Linagliptin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomised, double-blind, placebo-controlled, parallel group study. Whilst 1263 were randomised, only 1261 were treated.

Reporting Groups
  Description
Placebo 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.
Linagliptin 5 mg 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.

Participant Flow:   Overall Study
    Placebo     Linagliptin 5 mg  
STARTED     630     631  
COMPLETED     520     543  
NOT COMPLETED     110     88  
Adverse Event                 33                 25  
Lack of Efficacy                 17                 3  
Protocol Violation                 5                 7  
Lost to Follow-up                 8                 14  
Withdrawal by Subject                 26                 21  
Unknown                 21                 18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 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.
Linagliptin 5 mg 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 Total of all reporting groups

Baseline Measures
    Placebo     Linagliptin 5 mg     Total  
Number of Participants  
[units: participants]
  630     631     1261  
Age  
[units: Years]
Mean ± Standard Deviation
  60.4  ± 10.0     59.7  ± 9.9     60.0  ± 10.0  
Gender  
[units: Participants]
     
Female     301     302     603  
Male     329     329     658  
Baseline HbA1c [1]
[units: Percentage]
Mean ± Standard Deviation
  8.29  ± 0.85     8.31  ± 0.85     8.30  ± 0.85  
[1] 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
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c After 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Number of Patients With HbA1c < 7.0 Percent   [ Time Frame: 24 and 52 weeks ]

3.  Secondary:   Number of Patients Lowering HbA1c by at Least 0.5 Percent   [ Time Frame: 24 and 52 weeks ]

4.  Secondary:   Change From Baseline in HbA1c by Visit at Week 6   [ Time Frame: Baseline and 6 weeks ]

5.  Secondary:   Change From Baseline in HbA1c by Visit at Week 12   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Change From Baseline in HbA1c by Visit at Week 18   [ Time Frame: Baseline and 18 weeks ]

7.  Secondary:   Change From Baseline in HbA1c by Visit at Week 32   [ Time Frame: Baseline and 32 weeks ]

8.  Secondary:   Change From Baseline in HbA1c by Visit at Week 40   [ Time Frame: Baseline and 40 weeks ]

9.  Secondary:   Change From Baseline in HbA1c by Visit at Week 52   [ Time Frame: Baseline and 52 weeks ]

10.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment   [ Time Frame: Baseline and 24 weeks ]

11.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

12.  Secondary:   Change From Baseline in FPG   [ Time Frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks ]

13.  Secondary:   Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

14.  Secondary:   Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment   [ Time Frame: Baseline, 24 and 52 weeks ]

15.  Secondary:   Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment   [ Time Frame: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner ]

16.  Other Pre-specified:   Number of Patients With HbA1c < 6.5 Percent   [ Time Frame: 24 and 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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:
unchecked 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.
unchecked 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.


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 by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00954447     History of Changes
Other Study ID Numbers: 1218.36, 2008-008296-33
Study First Received: August 6, 2009
Results First Received: August 28, 2012
Last Updated: December 4, 2013
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