Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: BI 1356 dose 1 once daily; Drug: BI 1356 dose 2 once daily; Drug: BI 1356 dose 3 once daily; Drug: Metformin

• Registration Number: NCT00328172
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-18
• Study First Submitted QC: 2006-05-18
• Study First Posted: 2006-05-19
• Primary Completion: 2007-08
• Results First Submitted: 2011-05-13
• Results First Submitted QC: 2011-05-13
• Results First Posted: 2011-06-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-15
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets matching BI 1356
BI 1356 0.5 mg	BI 1356 dose 1 once daily	BI 1356 dose 1 once daily
BI 1356 2.5 mg	BI 1356 dose 2 once daily	BI 1356 dose 2 once daily
BI 1356 5.0 mg	BI 1356 dose 3 once daily	BI 1356 dose 3 once daily
Metformin	Metformin	Metformin

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12	Baseline, week 12	The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12	Baseline, week 12	Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks	Baseline, week 12	An absolute efficacy response is defined as HbA1c \<= 7.0% at 12 weeks. A non-response is defined as HbA1c \> 7.0% at 12 weeks.

Trial Locations

Locations (71)

1218.5.10020 Boehringer Ingelheim Investigational Site; 🇺🇸 Chula Vista, California, United States

1218.5.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 La Jolla, California, United States

1218.5.10007 Boehringer Ingelheim Investigational Site; 🇺🇸 Walnut Creek, California, United States

1218.5.10041 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1218.5.10018 Boehringer Ingelheim Investigational Site; 🇺🇸 Hollywood, Florida, United States

1218.5.10016 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, Florida, United States

1218.5.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.5.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.5.10012 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

1218.5.10017 Boehringer Ingelheim Investigational Site; 🇺🇸 Indianapolis, Indiana, United States

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