ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00309608
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : June 15, 2011
Last Update Posted : July 8, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

March 31, 2006
April 3, 2006
May 13, 2011
June 15, 2011
July 8, 2014
April 2006
August 2007   (Final data collection date for primary outcome measure)
HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
The primary endpoint in this study is the change of HbA1c from baseline to week 12.
Complete list of historical versions of study NCT00309608 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With HbA1c<=7.0% at Week 12 [ Time Frame: week 12 ]
    Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.
  • Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]
    This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
The secondary endpoints are the change of fasting plasma glucose after 12 weeks of treatment compared to baseline and the occurrence of an absolute efficacy response, that is an HbA1c under treatment of <= 7.0%
Not Provided
Not Provided
 
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Linagliptin
    Linagliptin medium dose tablet once daily
  • Drug: Linagliptin
    Linagliptin high dose tablet once daily
  • Drug: Linagliptin
    Linagliptin low dose tablet once daily
  • Drug: Placebo
    Placebo tablets once daily
  • Drug: Glimepiride
    Glimepiride tablets once daily
  • Experimental: Linagliptin low dose
    Patients receive Linagliptin low dose tablets once daily
    Intervention: Drug: Linagliptin
  • Experimental: Linagliptin medium dose
    Patients receive Linagliptin medium dose tablets once daily
    Intervention: Drug: Linagliptin
  • Experimental: Linagliptin high dose
    Patients receive Linagliptin high dose tablets once daily
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    Patients receive tablets identical to those containing Linagliptin low, medium and high dose
    Intervention: Drug: Placebo
  • Active Comparator: Glimepiride
    Patients receive Glimepiride tablets once daily
    Intervention: Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
333
375
Not Provided
August 2007   (Final data collection date for primary outcome measure)

Inclusion criteria:

Inclusion_Criteria:

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
  • HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
  • HbA1c 7.5 10.0% at screening for patients treated with metformin alone
  • HbA1c 7.5 10.0% at beginning of the placebo run-in phase
  • Age > 21 and < 75 years
  • MI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion criteria:

Exclusion_Criteria:

  • Clinically relevant cardiovascular disease
  • Impaired hepatic function
  • Renal insufficiency or impaired renal function
  • Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  • Treatment with insulin within 3 months prior to screening
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Slovakia,   Sweden,   Ukraine,   United Kingdom
 
 
NCT00309608
1218.6
2005-004597-24 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP