Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

June 17, 2014 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

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

  • Argentina
      • Capital Federal, Argentina
        • 1218.35.54003 Boehringer Ingelheim Investigational Site
      • Corrientes, Argentina
        • 1218.35.54005 Boehringer Ingelheim Investigational Site
      • Mar del Plata, Argentina
        • 1218.35.54001 Boehringer Ingelheim Investigational Site
      • Parque Velez Sarfield, Argentina
        • 1218.35.54006 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 1218.35.36001 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1218.35.36002 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1218.35.36004 Boehringer Ingelheim Investigational Site
      • Budapest, Hungary
        • 1218.35.36005 Boehringer Ingelheim Investigational Site
      • Debrecen, Hungary
        • 1218.35.36003 Boehringer Ingelheim Investigational Site
  • India
      • Aligarh, Uttar Pradesh, India
        • 1218.35.91003 Boehringer Ingelheim Investigational Site
      • Aminjikarai, Tamilnadu, India
        • 1218.35.91007 Boehringer Ingelheim Investigational Site
      • Bangalore, Karnataka, India
        • 1218.35.91001 Boehringer Ingelheim Investigational Site
      • Bangalore, Karnataka, India
        • 1218.35.91004 Boehringer Ingelheim Investigational Site
      • Indore, India
        • 1218.35.91002 Boehringer Ingelheim Investigational Site
      • Mumbai, Maharastra, India
        • 1218.35.91008 Boehringer Ingelheim Investigational Site
      • Nagpur, Maharashtra, India
        • 1218.35.91005 Boehringer Ingelheim Investigational Site
      • Pune, Maharastra, India
        • 1218.35.91006 Boehringer Ingelheim Investigational Site
  • Japan
      • Osaka, Osaka, Japan
        • 1218.35.81003 Boehringer Ingelheim Investigational Site
      • Shinjyuku-ku,Tokyo, Japan
        • 1218.35.81001 Boehringer Ingelheim Investigational Site
      • Suita, Osaka,, Japan
        • 1218.35.81002 Boehringer Ingelheim Investigational Site
  • Poland
      • Bialystok, Poland
        • 1218.35.48002 Boehringer Ingelheim Investigational Site
      • Lublin, Poland
        • 1218.35.48004 Boehringer Ingelheim Investigational Site
      • Poznan, Poland
        • 1218.35.48003 Boehringer Ingelheim Investigational Site
      • Rzeszow, Poland
        • 1218.35.48001 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 1218.35.48005 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • 1218.35.70008 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.35.70001 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.35.70002 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.35.70003 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.35.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.35.70009 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1218.35.70007 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1218.35.10002 Boehringer Ingelheim Investigational Site
    • California
      • Los Angeles, California, United States
        • 1218.35.10001 Boehringer Ingelheim Investigational Site
      • National City, California, United States
        • 1218.35.10016 Boehringer Ingelheim Investigational Site
    • Florida
      • Ft. Lauderdale, Florida, United States
        • 1218.35.10017 Boehringer Ingelheim Investigational Site
      • Ft. Lauderdale, Florida, United States
        • 1218.35.10021 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1218.35.10013 Boehringer Ingelheim Investigational Site
    • Michigan
      • Flint, Michigan, United States
        • 1218.35.10015 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States
        • 1218.35.10018 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1218.35.10004 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 1218.35.10005 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States
        • 1218.35.10020 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.35.10009 Boehringer Ingelheim Investigational Site
      • Sugar Land, Texas, United States
        • 1218.35.10019 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 [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug

Exclusion criteria:

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage 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
Active Comparator: BI 1356
5 mg orally (po) once daily
Drug: BI 1356
5mg orally (po) tablet qd
Placebo Comparator: Placebo
one tablet once daily
Drug: Placebo
Placebo matching BI 1356 5mg one tablet daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18
Time Frame: Baseline, week 18
HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline, week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose at Week 18
Time Frame: Baseline, week 18
Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Baseline, week 18
Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18
Time Frame: week 18
An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.
week 18
Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18
Time Frame: week 18
An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.
week 18
Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18
Time Frame: Baseline, week 18
An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.
Baseline, week 18
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6
Time Frame: Baseline, week 6
HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline, week 6
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12
Time Frame: Baseline, week 12
HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline, week 12
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18
Time Frame: Baseline, week 18
HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Baseline, week 18
Change From Baseline in Fasting Plasma Glucose at Week 6
Time Frame: Baseline, week 6
Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Baseline, week 6
Change From Baseline in Fasting Plasma Glucose at Week 12
Time Frame: Baseline, week 12
Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Baseline, week 12

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

December 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

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

  • 1218.35
  • 2008-003118-86 (EudraCT Number: EudraCT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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