Text Size

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00622284
First received: February 13, 2008
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
Results First Received: November 30, 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: Placebo identical to BI 1356 5mg
Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Drug: BI 1356
Drug: Glimepiride

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were in total 1560 patients randomised in the study. Of these, 1 patient was not treated. The remaining 8 patients not accounted for in the treated set were removed from all study analyses (explained in trial report) due to major good-clinical-practice violations at the site, and the inability to verify the validity of any patient level data.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Participant Flow:   Overall Study
    Linagliptin     Glimepiride  
STARTED     776 [1]   775 [2]
COMPLETED     587 [3]   604 [3]
NOT COMPLETED     189     171  
Lack of Efficacy                 45                 15  
Adverse Event                 61                 90  
Protocol Violation                 12                 5  
Lost to Follow-up                 11                 13  
Withdrawal by Subject                 27                 24  
Other reason (not specified)                 33                 24  
[1] Number who started treatment. One patient in the Linagliptin group was randomized but not treated.
[2] Number who started treatment.
[3] Number who completed treatment.



  Baseline Characteristics
  Show Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1c Change From Baseline at Week 52   [ Time Frame: Baseline and week 52 ]
  Show Outcome Measure 1

2.  Primary:   HbA1c Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 2

3.  Secondary:   Body Weight Change From Baseline at Week 52   [ Time Frame: Baseline and week 52 ]
  Show Outcome Measure 3

4.  Secondary:   Body Weight Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 4

5.  Secondary:   Incidence of Hypoglycaemic Events up to 52 Weeks   [ Time Frame: Week 52 ]
  Show Outcome Measure 5

6.  Secondary:   Incidence of Hypoglycaemic Events up to 104 Weeks   [ Time Frame: Week 104 ]
  Show Outcome Measure 6

7.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at Week 52   [ Time Frame: Baseline and week 52 ]
  Show Outcome Measure 7

8.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 52   [ Time Frame: Week 52 ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 104   [ Time Frame: Week 104 ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Patients With HbA1c <6.5% at Week 52   [ Time Frame: Week 52 ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Patients With HbA1c <6.5% at Week 104   [ Time Frame: Week 104 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Patients With HbA1c Lowering by 0.5% at Week 104   [ Time Frame: Week 104 ]
  Show Outcome Measure 13

14.  Secondary:   2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 14

15.  Secondary:   HbA1c Change at Week 4   [ Time Frame: Baseline and week 4 ]
  Show Outcome Measure 15

16.  Secondary:   HbA1c Change at Week 8   [ Time Frame: Baseline and week 8 ]
  Show Outcome Measure 16

17.  Secondary:   HbA1c Change at Week 12   [ Time Frame: Baseline and week 12 ]
  Show Outcome Measure 17

18.  Secondary:   HbA1c Change at Week 16   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 18

19.  Secondary:   HbA1c Change at Week 28   [ Time Frame: Baseline and week 28 ]
  Show Outcome Measure 19

20.  Secondary:   HbA1c Change at Week 40   [ Time Frame: Baseline and week 40 ]
  Show Outcome Measure 20

21.  Secondary:   HbA1c Change at Week 52   [ Time Frame: Baseline and week 52 ]
  Show Outcome Measure 21

22.  Secondary:   HbA1c Change at Week 65   [ Time Frame: Baseline and week 65 ]
  Show Outcome Measure 22

23.  Secondary:   HbA1c Change at Week 78   [ Time Frame: Baseline and week 78 ]
  Show Outcome Measure 23

24.  Secondary:   HbA1c Change at Week 91   [ Time Frame: Baseline and week 91 ]
  Show Outcome Measure 24

25.  Secondary:   HbA1c Change at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 25

26.  Secondary:   Change in Baseline Lipid Parameter Cholesterol at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 26

27.  Secondary:   Change in Baseline Lipid Parameter HDL at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 27

28.  Secondary:   Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 28

29.  Secondary:   Change in Baseline Lipid Parameter Triglyceride at Week 104   [ Time Frame: Baseline and week 104 ]
  Show Outcome Measure 29


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide 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.
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.


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
With the exception of HbA1c<6.5% and HbA1c<7.0% at Week52, all other endpoints are presented in the Week52 repeated analysis within the final clinical trial report, where discrepancies between interim and final results are also explained.  


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 Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00622284     History of Changes
Other Study ID Numbers: 1218.20, 2007-004585-40
Study First Received: February 13, 2008
Results First Received: November 30, 2011
Last Updated: November 30, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Denmark: Danish Medicines Agency
France: AFSSAPS 143/147, bld Anatole France 93285 Saint-Denis Cedex FRANCE
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Italy: Comitato Etico Locale per la Sperimentazione Clinica dei Medicinali A.O. Universitaria Senese - Località Le Scotte - SIENA
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Poland: Registration Medicinal Product Medical Device Biocidal Product
South Africa: Medicines Control Council
Sweden: Sweden; Läkemedelsverket (Medical Product Agency)
United States: Food and Drug Administration