A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Phase 3

Completed

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

• Registration Number: NCT00740051
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Primary Completion: 2010-08
• Results First Submitted: 2011-08-03
• Results First Submitted QC: 2011-09-19
• Results First Posted: 2011-10-26
• Status Verified: 2013-12
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Linagliptin Placebo	First 18 weeks of treatment
Linagliptin	Linagliptin	52 week treatment
Glimepiride	Glimepiride	Placebo patients switch to glimepiride week19-52

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 18 (Interim Analysis)	Baseline and week 18	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
HbA1c Change From Baseline at Week 18 (Final Analysis)	Baseline and week 18	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)	Baseline and week 18	This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).
Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)	Week 18	Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)	Week 18	Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)	Week 18	Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
The Change in HbA1c From Baseline by Visit Over Time	Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52	HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.
The Change in FPG From Baseline by Visit Over Time	Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52	This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.

Trial Locations

Locations (53)

1218.50.10009 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1218.50.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Peoria, Arizona, United States

1218.50.10013 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenbrae, California, United States

1218.50.10016 Boehringer Ingelheim Investigational Site; 🇺🇸 Harbor City, California, United States

1218.50.10017 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Park, California, United States

1218.50.10006 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1218.50.10007 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.50.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Statesville, North Carolina, United States

1218.50.10002 Boehringer Ingelheim Investigational Site; 🇺🇸 Eugene, Oregon, United States

1218.50.10015 Boehringer Ingelheim Investigational Site; 🇺🇸 Greer, South Carolina, United States

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