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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.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00819091
First received: January 7, 2009
Last updated: June 17, 2014
Last verified: December 2013
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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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.
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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
Total Total of all reporting groups

Baseline Measures
   Placebo   Linagliptin 5.0 mg   Total 
Overall Participants Analyzed 
[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 ]

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

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

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

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

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

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

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

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

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


  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
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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:
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


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

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00819091     History of Changes
Other Study ID Numbers: 1218.35
2008-003118-86 ( EudraCT Number: EudraCT )
Study First Received: January 7, 2009
Results First Received: May 13, 2011
Last Updated: June 17, 2014
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