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

February 15, 2014 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2

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

  • Australia
    • New South Wales
      • Miranda, New South Wales, Australia
        • 1218.5.61001 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 1218.5.61005 Boehringer Ingelheim Investigational Site
      • Dandenong, Victoria, Australia
        • 1218.5.61006 Boehringer Ingelheim Investigational Site
      • East Ringwood, Victoria, Australia
        • 1218.5.61007 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia
        • 1218.5.61004 Boehringer Ingelheim Investigational Site
      • Nedlands, Western Australia, Australia
        • 1218.5.61002 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1218.5.11011 Boehringer Ingelheim Investigational Site
      • Calgary, Alberta, Canada
        • 1218.5.11016 Boehringer Ingelheim Investigational Site
      • Red Deer, Alberta, Canada
        • 1218.5.11003 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1218.5.11004 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada
        • 1218.5.11013 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1218.5.11015 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1218.5.11005 Boehringer Ingelheim Investigational Site
      • Oakville, Ontario, Canada
        • 1218.5.11014 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1218.5.11010 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1218.5.11009 Boehringer Ingelheim Investigational Site
      • Thornhill, Ontario, Canada
        • 1218.5.11012 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1218.5.11002 Boehringer Ingelheim Investigational Site
    • Prince Edward Island
      • Montague, Prince Edward Island, Canada
        • 1218.5.11006 Boehringer Ingelheim Investigational Site
    • Quebec
      • Sainte-Foy, Quebec, Canada
        • 1218.5.11017 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 1218.5.11018 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Olomouc 9, Czech Republic
        • 1218.5.42002 Boehringer Ingelheim Investigational Site
      • Praha 4, Czech Republic
        • 1218.5.42003 Boehringer Ingelheim Investigational Site
      • Praha 4, Czech Republic
        • 1218.5.42005 Boehringer Ingelheim Investigational Site
      • Praha 9, Czech Republic
        • 1218.5.42004 Boehringer Ingelheim Investigational Site
      • Sternberk, Czech Republic
        • 1218.5.42001 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1218.5.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.5.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.5.70003 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.5.70004 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.5.70005 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkov, Ukraine
        • 1218.5.38005 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.5.38001 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.5.38002 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.5.38003 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1218.5.38004 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ukraine
        • 1218.5.38006 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Chula Vista, California, United States
        • 1218.5.10020 Boehringer Ingelheim Investigational Site
      • La Jolla, California, United States
        • 1218.5.10001 Boehringer Ingelheim Investigational Site
      • Walnut Creek, California, United States
        • 1218.5.10007 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 1218.5.10041 Boehringer Ingelheim Investigational Site
    • Florida
      • Hollywood, Florida, United States
        • 1218.5.10018 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1218.5.10016 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.5.10003 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.5.10011 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 1218.5.10012 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 1218.5.10017 Boehringer Ingelheim Investigational Site
    • Kansas
      • Topeka, Kansas, United States
        • 1218.5.10008 Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, United States
        • 1218.5.10024 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1218.5.10039 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States
        • 1218.5.10032 Boehringer Ingelheim Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States
        • 1218.5.10025 Boehringer Ingelheim Investigational Site
    • Montana
      • Butte, Montana, United States
        • 1218.5.10034 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1218.5.10009 Boehringer Ingelheim Investigational Site
    • New York
      • Albany, New York, United States
        • 1218.5.10042 Boehringer Ingelheim Investigational Site
      • Endwell, New York, United States
        • 1218.5.10029 Boehringer Ingelheim Investigational Site
      • New Hyde Park, New York, United States
        • 1218.5.10004 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • 1218.5.10026 Boehringer Ingelheim Investigational Site
      • Mentor, Ohio, United States
        • 1218.5.10035 Boehringer Ingelheim Investigational Site
    • Oregon
      • Medford, Oregon, United States
        • 1218.5.10023 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1218.5.10030 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States
        • 1218.5.10044 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, United States
        • 1218.5.10033 Boehringer Ingelheim Investigational Site
      • Simpsonville, South Carolina, United States
        • 1218.5.10038 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.5.10006 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.5.10040 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.5.10036 Boehringer Ingelheim Investigational Site
      • Tyler, Texas, United States
        • 1218.5.10021 Boehringer Ingelheim Investigational Site
    • Virginia
      • Salem, Virginia, United States
        • 1218.5.10027 Boehringer Ingelheim Investigational Site
    • Washington
      • Federal Way, Washington, United States
        • 1218.5.10022 Boehringer Ingelheim Investigational Site
      • Renton, Washington, United States
        • 1218.5.10014 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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
  2. Diagnosis of Type 2 diabetes with duration of at least 3 months

  3. Glycosylated haemoglobin A1 (HbA1c) of:

    7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)

  4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
  5. Age >=21 and <=75 years.
  6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2.
  7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

  1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
  2. Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
  3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
  5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
  6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
  7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  8. Treatment with insulin within 3 months prior to screening
  9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)

  12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

    1. are not surgically sterile,
    2. or are nursing or pregnant;
    3. 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 throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
  13. Intolerance of metformin

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
Placebo Comparator: Placebo
Placebo tablets matching BI 1356
Drug: Placebo
Placebo matching BI 1356
Experimental: BI 1356 0.5 mg
BI 1356 dose 1 once daily
Drug: BI 1356 dose 1 once daily
BI 1356 dose 1 once daily
Experimental: BI 1356 2.5 mg
BI 1356 dose 2 once daily
Drug: BI 1356 dose 2 once daily
BI 1356 dose 2 once daily
Experimental: BI 1356 5.0 mg
BI 1356 dose 3 once daily
Drug: BI 1356 dose 3 once daily
BI 1356 dose 3 once daily
Active Comparator: Metformin
Drug: Metformin
Metformin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) 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.
Baseline, week 12
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks
Time Frame: 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.
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.

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

May 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

February 15, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.5

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 Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe