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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Linagliptin; Drug: Glimepiride

• Registration Number: NCT00309608
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study Start: 2006-04
• Study First Posted: 2006-04-03
• Primary Completion: 2007-08
• Results First Submitted: 2011-05-13
• Results First Submitted QC: 2011-05-13
• Results First Posted: 2011-06-15
• Status Verified: 2013-12
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients receive tablets identical to those containing Linagliptin low, medium and high dose
Linagliptin low dose	Linagliptin	Patients receive Linagliptin low dose tablets once daily
Linagliptin medium dose	Linagliptin	Patients receive Linagliptin medium dose tablets once daily
Linagliptin high dose	Linagliptin	Patients receive Linagliptin high dose tablets once daily
Glimepiride	Glimepiride	Patients receive Glimepiride tablets once daily

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12	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.
Percentage of Patients With HbA1c<=7.0% at Week 12	week 12	Descriptive calculation of Patients with HbA1c \<= 7.0% at Week 12.

Trial Locations

Locations (48)

1218.6.3304A Boehringer Ingelheim Investigational Site; 🇫🇷 Joue les Tours, France

1218.6.3305A Euraxi Pharma; 🇫🇷 Joue les Tours, France

1218.6.3302A Boehringer Ingelheim Investigational Site; 🇫🇷 Joué les Tours, France

1218.6.3303A Boehringer Ingelheim Investigational Site; 🇫🇷 Joué Les Tours, France

1218.6.3301A Boehringer Ingelheim Investigational Site; 🇫🇷 Paris cedex 13, France

1218.6.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 Aschaffenburg, Germany

1218.6.49013 Boehringer Ingelheim Investigational Site; 🇩🇪 Bosenheim, Germany

1218.6.49008 Boehringer Ingelheim Investigational Site; 🇩🇪 Dresden, Germany

1218.6.49009 Boehringer Ingelheim Investigational Site; 🇩🇪 Düsseldorf, Germany

1218.6.49014 Boehringer Ingelheim Investigational Site; 🇩🇪 Heidelberg, Germany

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