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

June 17, 2014 updated by: Boehringer Ingelheim

A Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • 1218.50.11001 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1218.50.11003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Sarnia, Ontario, Canada
        • 1218.50.11005 Boehringer Ingelheim Investigational Site
    • Prince Edward Island
      • Montague, Prince Edward Island, Canada
        • 1218.50.11002 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 1218.50.11004 Boehringer Ingelheim Investigational Site
  • Mexico
      • Aguascalientes, Mexico
        • 1218.50.52007 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1218.50.52010 Boehringer Ingelheim Investigational Site
      • León, Mexico
        • 1218.50.52009 Boehringer Ingelheim Investigational Site
      • Mexico, Mexico
        • 1218.50.52002 Boehringer Ingelheim Investigational Site
      • Mexico, Mexico
        • 1218.50.52008 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1218.50.52001 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1218.50.52003 Boehringer Ingelheim Investigational Site
      • México, Mexico
        • 1218.50.52004 Boehringer Ingelheim Investigational Site
      • México, Mexico
        • 1218.50.52005 Boehringer Ingelheim Investigational Site
  • Philippines
      • Cebu, Philippines
        • 1218.50.63003 Boehringer Ingelheim Investigational Site
      • Cebu, Philippines
        • 1218.50.63005 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1218.50.63006 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1218.50.63008 Boehringer Ingelheim Investigational Site
      • Marikina, Philippines
        • 1218.50.63001 Boehringer Ingelheim Investigational Site
      • Marikina, Philippines
        • 1218.50.63004 Boehringer Ingelheim Investigational Site
      • Pasay, Philippines
        • 1218.50.63007 Boehringer Ingelheim Investigational Site
      • Pasig, Philippines
        • 1218.50.63002 Boehringer Ingelheim Investigational Site
      • Pasig, Philippines
        • 1218.50.63009 Boehringer Ingelheim Investigational Site
  • Romania
      • Brasov, Romania
        • 1218.50.40004 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1218.50.40001 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1218.50.40002 Boehringer Ingelheim Investigational Site
      • Galati, Romania
        • 1218.50.40005 Boehringer Ingelheim Investigational Site
      • Sibiu, Romania
        • 1218.50.40003 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1218.50.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.50.70003 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.50.70002 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.50.70004 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.50.70005 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkiv, Ukraine
        • 1218.50.38002 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.50.38001 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.50.38004 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1218.50.38003 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ukraine
        • 1218.50.38005 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1218.50.10009 Boehringer Ingelheim Investigational Site
    • Arizona
      • Peoria, Arizona, United States
        • 1218.50.10011 Boehringer Ingelheim Investigational Site
    • California
      • Greenbrae, California, United States
        • 1218.50.10013 Boehringer Ingelheim Investigational Site
      • Harbor City, California, United States
        • 1218.50.10016 Boehringer Ingelheim Investigational Site
      • Huntington Park, California, United States
        • 1218.50.10017 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1218.50.10006 Boehringer Ingelheim Investigational Site
    • Florida
      • Miami, Florida, United States
        • 1218.50.10007 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Statesville, North Carolina, United States
        • 1218.50.10004 Boehringer Ingelheim Investigational Site
    • Oregon
      • Eugene, Oregon, United States
        • 1218.50.10002 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greer, South Carolina, United States
        • 1218.50.10015 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States
        • 1218.50.10005 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.50.10012 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1218.50.10022 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.50.10010 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.50.10018 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Linagliptin
52 week treatment
Drug: Linagliptin
5mg once daily
Placebo Comparator: Placebo
First 18 weeks of treatment
Drug: Linagliptin Placebo
0 mg placebo comparator for part 1 of study (to 18 weeks)
Active Comparator: Glimepiride
Placebo patients switch to glimepiride week19-52
Drug: Glimepiride
1-4mg for part 2 of study (weeks 19-52)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline at Week 18 (Interim Analysis)
Time Frame: 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.
Baseline and week 18
HbA1c Change From Baseline at Week 18 (Final Analysis)
Time Frame: 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.
Baseline and week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)
Time Frame: 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).
Baseline and week 18
Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)
Time Frame: Week 18
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Week 18
Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)
Time Frame: Week 18
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Week 18
Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)
Time Frame: Week 18
Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
Week 18
The Change in HbA1c From Baseline by Visit Over Time
Time Frame: 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.
Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52
The Change in FPG From Baseline by Visit Over Time
Time Frame: 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.
Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.50
  • 2007-007485-38 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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