Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

February 24, 2014 updated by: Boehringer Ingelheim

A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

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

  • France
      • Besancon, France
        • 1218.61.3301A Boehringer Ingelheim Investigational Site
      • Beziers, France
        • 1218.61.3306A Boehringer Ingelheim Investigational Site
      • Beziers, France
        • 1218.61.3311A Boehringer Ingelheim Investigational Site
      • Bourg des cptes, France
        • 1218.61.3309A Boehringer Ingelheim Investigational Site
      • Cournonterral, France
        • 1218.61.3310A Boehringer Ingelheim Investigational Site
      • Laval, France
        • 1218.61.3312A Boehringer Ingelheim Investigational Site
      • Louvigne De bais, France
        • 1218.61.3313A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1218.61.3305A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1218.61.3307A Boehringer Ingelheim Investigational Site
  • India
      • Bangalore, India
        • 1218.61.91002 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.61.91003 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.61.91004 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 1218.61.91008 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 1218.61.91009 Boehringer Ingelheim Investigational Site
      • Karnataka, India
        • 1218.61.91010 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 1218.61.91001 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 1218.61.91006 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 1218.61.91011 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1218.61.91005 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1218.61.91007 Boehringer Ingelheim Investigational Site
  • Philippines
      • Cebu City, Philippines
        • 1218.61.63003 Boehringer Ingelheim Investigational Site
      • Cebu City, Philippines
        • 1218.61.63004 Boehringer Ingelheim Investigational Site
      • Davao City, Philippines
        • 1218.61.63002 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Escondido, California, United States
        • 1218.61.01028 Boehringer Ingelheim Investigational Site
      • Greenbrae, California, United States
        • 1218.61.01014 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1218.61.01015 Boehringer Ingelheim Investigational Site
      • Paramount, California, United States
        • 1218.61.01042 Boehringer Ingelheim Investigational Site
      • Poway, California, United States
        • 1218.61.01046 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1218.61.01044 Boehringer Ingelheim Investigational Site
    • Florida
      • Miami, Florida, United States
        • 1218.61.01009 Boehringer Ingelheim Investigational Site
    • Georgia
      • Lawrenceville, Georgia, United States
        • 1218.61.01049 Boehringer Ingelheim Investigational Site
      • Roswell, Georgia, United States
        • 1218.61.01008 Boehringer Ingelheim Investigational Site
    • Idaho
      • Meridian, Idaho, United States
        • 1218.61.01040 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1218.61.01016 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1218.61.01018 Boehringer Ingelheim Investigational Site
    • Indiana
      • Lafayette, Indiana, United States
        • 1218.61.01048 Boehringer Ingelheim Investigational Site
    • Maine
      • Auburn, Maine, United States
        • 1218.61.01001 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States
        • 1218.61.01043 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1218.61.01052 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1218.61.01030 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States
        • 1218.61.01007 Boehringer Ingelheim Investigational Site
      • Jacksonville, North Carolina, United States
        • 1218.61.01004 Boehringer Ingelheim Investigational Site
      • Wilmington, North Carolina, United States
        • 1218.61.01023 Boehringer Ingelheim Investigational Site
    • Ohio
      • Perrysburg, Ohio, United States
        • 1218.61.01027 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • 1218.61.01031 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, United States
        • 1218.61.01017 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.61.01005 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.61.01006 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.61.01053 Boehringer Ingelheim Investigational Site
      • Sugar Land, Texas, United States
        • 1218.61.01003 Boehringer Ingelheim Investigational Site
    • Vermont
      • Bennington, Vermont, United States
        • 1218.61.01024 Boehringer Ingelheim Investigational Site
    • Washington
      • Spokane, Washington, United States
        • 1218.61.01020 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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Diagnosis of diabetes mellitus prior to informed consent
  2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
  3. Glycosylated haemoglobin A1 >= 7.5% and <= 10%
  4. Age between 18 and less than 80
  5. - Body Mass index less or equal to 45

Exclusion criteria:

  1. Uncontrolled hyperglycaemia during run in period
  2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
  3. Impaired hepatic function
  4. Gastric by pass surgery
  5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
  6. Treatment with anti-obesity drugs
  7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial

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
Linagliptin tablets once daily
Drug: Linagliptin
Linagliptin tablets once daily
Placebo Comparator: Placebo
Placebo tablets once daily
Drug: Placebo
Placebo matching linagliptin tablets once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Time Frame: baseline, 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
Time Frame: baseline, 6 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
baseline, 6 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
Time Frame: baseline, 12 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
baseline, 12 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
Time Frame: baseline, 18 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
baseline, 18 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Time Frame: 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
24 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Time Frame: 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
24 weeks
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Time Frame: 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
Time Frame: baseline, 24 weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24
baseline, 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks
Time Frame: baseline, 6 weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6
baseline, 6 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks
Time Frame: baseline, 12 weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12
baseline, 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks
Time Frame: baseline, 18 weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18
baseline, 18 weeks

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

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

October 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.61
  • 2009-013289-20 (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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Linagliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe