Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study

December 12, 2013 updated by: Boehringer Ingelheim

A Phase IIIb, 24-week, Randomised, Placebo-controlled, Double-blinded, Efficacy and Safety Study of Linagliptin (BI 1356) in Black/African American Patients With Type 2 Diabetes With a MTT Sub-study

Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1218.75.059 Boehringer Ingelheim Investigational Site
      • Huntsville, Alabama, United States
        • 1218.75.054 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 1218.75.035 Boehringer Ingelheim Investigational Site
      • Toney, Alabama, United States
        • 1218.75.101 Boehringer Ingelheim Investigational Site
    • Alaska
      • Little Rock, Alaska, United States
        • 1218.75.066 Boehringer Ingelheim Investigational Site
      • Pell City, Alaska, United States
        • 1218.75.008 Boehringer Ingelheim Investigational Site
    • California
      • Anaheim, California, United States
        • 1218.75.071 Boehringer Ingelheim Investigational Site
      • Chino, California, United States
        • 1218.75.018 Boehringer Ingelheim Investigational Site
      • Garden Grove, California, United States
        • 1218.75.081 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1218.75.109 Boehringer Ingelheim Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • 1218.75.040 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 1218.75.047 Boehringer Ingelheim Investigational Site
    • Florida
      • Bartow, Florida, United States
        • 1218.75.106 Boehringer Ingelheim Investigational Site
      • Bradenton, Florida, United States
        • 1218.75.098 Boehringer Ingelheim Investigational Site
      • Chiefland, Florida, United States
        • 1218.75.036 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, United States
        • 1218.75.105 Boehringer Ingelheim Investigational Site
      • Fort Myers, Florida, United States
        • 1218.75.083 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, United States
        • 1218.75.002 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1218.75.080 Boehringer Ingelheim Investigational Site
      • Jupiter, Florida, United States
        • 1218.75.065 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.75.007 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.75.029 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.75.045 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.75.084 Boehringer Ingelheim Investigational Site
      • Ocala, Florida, United States
        • 1218.75.017 Boehringer Ingelheim Investigational Site
      • Pinellas Park, Florida, United States
        • 1218.75.012 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, United States
        • 1218.75.074 Boehringer Ingelheim Investigational Site
      • South Miami, Florida, United States
        • 1218.75.076 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 1218.75.003 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, United States
        • 1218.75.039 Boehringer Ingelheim Investigational Site
      • Tallahassee, Florida, United States
        • 1218.75.075 Boehringer Ingelheim Investigational Site
      • Tamarac, Florida, United States
        • 1218.75.100 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1218.75.015 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 1218.75.103 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 1218.75.049 Boehringer Ingelheim Investigational Site
      • Calhoun, Georgia, United States
        • 1218.75.067 Boehringer Ingelheim Investigational Site
      • Dunwoody, Georgia, United States
        • 1218.75.016 Boehringer Ingelheim Investigational Site
      • Lawrenceville, Georgia, United States
        • 1218.75.063 Boehringer Ingelheim Investigational Site
      • Marietta, Georgia, United States
        • 1218.75.056 Boehringer Ingelheim Investigational Site
      • Rosswell, Georgia, United States
        • 1218.75.026 Boehringer Ingelheim Investigational Site
      • Sandy Springs, Georgia, United States
        • 1218.75.079 Boehringer Ingelheim Investigational Site
      • Snellville, Georgia, United States
        • 1218.75.034 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1218.75.001 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1218.75.055 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Owensboro, Kentucky, United States
        • 1218.75.069 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • 1218.75.044 Boehringer Ingelheim Investigational Site
    • Maryland
      • Essex, Maryland, United States
        • 1218.75.108 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States
        • 1218.75.086 Boehringer Ingelheim Investigational Site
      • Watertown, Massachusetts, United States
        • 1218.75.087 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • 1218.75.051 Boehringer Ingelheim Investigational Site
      • Flint, Michigan, United States
        • 1218.75.088 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Biloxi, Mississippi, United States
        • 1218.75.099 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Atco, New Jersey, United States
        • 1218.75.006 Boehringer Ingelheim Investigational Site
      • Camden, New Jersey, United States
        • 1218.75.004 Boehringer Ingelheim Investigational Site
    • New York
      • Brooklyn, New York, United States
        • 1218.75.031 Boehringer Ingelheim Investigational Site
      • Brooklyn, New York, United States
        • 1218.75.095 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States
        • 1218.75.038 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, United States
        • 1218.75.009 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, United States
        • 1218.75.023 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, United States
        • 1218.75.060 Boehringer Ingelheim Investigational Site
      • Greensboro, North Carolina, United States
        • 1218.75.005 Boehringer Ingelheim Investigational Site
      • High Point, North Carolina, United States
        • 1218.75.107 Boehringer Ingelheim Investigational Site
      • Jacksonville, North Carolina, United States
        • 1218.75.020 Boehringer Ingelheim Investigational Site
      • Winston Salem, North Carolina, United States
        • 1218.75.027 Boehringer Ingelheim Investigational Site
    • Ohio
      • Akron, Ohio, United States
        • 1218.75.096 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 1218.75.090 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 1218.75.078 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1218.75.037 Boehringer Ingelheim Investigational Site
      • Philadelphia, Pennsylvania, United States
        • 1218.75.082 Boehringer Ingelheim Investigational Site
      • Uniontown, Pennsylvania, United States
        • 1218.75.010 Boehringer Ingelheim Investigational Site
      • Uniontown, Pennsylvania, United States
        • 1218.75.028 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States
        • 1218.75.091 Boehringer Ingelheim Investigational Site
      • Columbia, South Carolina, United States
        • 1218.75.072 Boehringer Ingelheim Investigational Site
      • Greenwood, South Carolina, United States
        • 1218.75.068 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, United States
        • 1218.75.097 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Brentwood, Tennessee, United States
        • 1218.75.024 Boehringer Ingelheim Investigational Site
      • Collierville, Tennessee, United States
        • 1218.75.025 Boehringer Ingelheim Investigational Site
      • Germantown, Tennessee, United States
        • 1218.75.011 Boehringer Ingelheim Investigational Site
      • Humboldt, Tennessee, United States
        • 1218.75.042 Boehringer Ingelheim Investigational Site
      • Memphis, Tennessee, United States
        • 1218.75.030 Boehringer Ingelheim Investigational Site
      • Memphis, Tennessee, United States
        • 1218.75.050 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.75.053 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.75.057 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.75.064 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1218.75.104 Boehringer Ingelheim Investigational Site
      • Houton, Texas, United States
        • 1218.75.043 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1218.75.022 Boehringer Ingelheim Investigational Site
      • Sugar Land, Texas, United States
        • 1218.75.058 Boehringer Ingelheim Investigational Site
      • Tomball, Texas, United States
        • 1218.75.033 Boehringer Ingelheim Investigational Site
      • Tomball, Texas, United States
        • 1218.75.102 Boehringer Ingelheim Investigational Site
      • Waco, Texas, United States
        • 1218.75.094 Boehringer Ingelheim Investigational Site
      • Whitney, Texas, United States
        • 1218.75.092 Boehringer Ingelheim Investigational Site
    • Virginia
      • Virgnia Beach, Virginia, United States
        • 1218.75.019 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:

  1. Dated written informed consent that is in accordance with GCP and local legislation.
  2. Male and female Black / African American patients
  3. Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
  4. HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
  5. Patients are currently treatment-naive or being treated with up to one oral antidiabetic medication. Antidiabetic medication is to be unchanged for at least 10 weeks prior to the informed consent.
  6. Age more than 18 and less than 80 years at Visit 1 (Screening).
  7. BMI (Body Mass Index) less than 45 kg/m2 at Visit 1.

Exclusion criteria:

  1. Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
  2. Type 1 diabetes.
  3. Impaired hepatic function, defined by serum levels of either alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1.
  4. Known prior hypersensitivity or allergy to the investigational product or its excipients.
  5. Treatment with insulin within 3 months prior to informed consent.
  6. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study.
  7. Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors.
  8. Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent.
  9. History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator.
  10. Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study.

  11. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:

    • are nursing or pregnant
    • are not surgically sterile
    • 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, intrauterine devices/systems (IUDs / IUSs), oral, implantable or injectable contraceptives, and vasectomised partners. No exceptions will be made.

    Hormonal birth control should have been in use for at least three months prior to signing informed consent and continue at least until the next menstrual period after completing the study.

  12. Current treatment with chronic use of systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  13. History of bariatric surgery.
  14. Patients who have demonstrated an inability to be compliant (80-120%) with the dosing regimen during the placebo run-in period.

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: Linagliptin
1 Tablet PO QD
Drug: Linagliptin
Active drug 1 tablet PO QD
Placebo Comparator: Placebo
1 Tablet PO QD
Drug: Placebo
1 Tablet PO QD

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
baseline, 24 weeks
Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks
Time Frame: baseline, 24 weeks
baseline, 24 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

September 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.75

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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