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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID: NCT01194830
Run by: Boehringer Ingelheim
People needed: 234
Starts: 2010-09-01
Expected to finish: 2011-10-01
Last updated by the study team: 2014-01-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Dated written informed consent that is in accordance with GCP and local legislation.
Male and female Black / African American patients
Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
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.
Age more than 18 and less than 80 years at Visit 1 (Screening).
BMI (Body Mass Index) less than 45 kg/m2 at Visit 1.

You may not qualify if…

Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
Type 1 diabetes.
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.
Known prior hypersensitivity or allergy to the investigational product or its excipients.
Treatment with insulin within 3 months prior to informed consent.
Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study.
Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors.
Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent.
History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator.
Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study.
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.
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.
History of bariatric surgery.
Patients who have demonstrated an inability to be compliant (80-120%) with the dosing regimen during the placebo run-in period.

Where it is running

1218.75.054 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
1218.75.035 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
1218.75.101 Boehringer Ingelheim Investigational Site — Toney, Alabama, United States
1218.75.066 Boehringer Ingelheim Investigational Site — Little Rock, Alaska, United States
1218.75.008 Boehringer Ingelheim Investigational Site — Pell City, Alaska, United States
1218.75.071 Boehringer Ingelheim Investigational Site — Anaheim, California, United States
1218.75.018 Boehringer Ingelheim Investigational Site — Chino, California, United States
1218.75.081 Boehringer Ingelheim Investigational Site — Garden Grove, California, United States
1218.75.109 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
1218.75.040 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
1218.75.047 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
1218.75.106 Boehringer Ingelheim Investigational Site — Bartow, Florida, United States
1218.75.098 Boehringer Ingelheim Investigational Site — Bradenton, Florida, United States
1218.75.036 Boehringer Ingelheim Investigational Site — Chiefland, Florida, United States
1218.75.105 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
1218.75.083 Boehringer Ingelheim Investigational Site — Fort Myers, Florida, United States
1218.75.002 Boehringer Ingelheim Investigational Site — Hialeah, Florida, United States
1218.75.080 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
1218.75.065 Boehringer Ingelheim Investigational Site — Jupiter, 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 — Miami, Florida, United States
1218.75.017 Boehringer Ingelheim Investigational Site — Ocala, Florida, United States
1218.75.059 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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