Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study
NCT ID: NCT01194830
Last Updated: 2014-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2010-09-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Linagliptin
1 Tablet PO QD
Linagliptin
Active drug 1 tablet PO QD
Placebo
1 Tablet PO QD
Placebo
1 Tablet PO QD
Interventions
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Linagliptin
Active drug 1 tablet PO QD
Placebo
1 Tablet PO QD
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1218.75.059 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
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
1218.75.012 Boehringer Ingelheim Investigational Site
Pinellas Park, Florida, United States
1218.75.074 Boehringer Ingelheim Investigational Site
Port Orange, Florida, United States
1218.75.076 Boehringer Ingelheim Investigational Site
South Miami, Florida, United States
1218.75.003 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
1218.75.039 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida, United States
1218.75.075 Boehringer Ingelheim Investigational Site
Tallahassee, Florida, United States
1218.75.100 Boehringer Ingelheim Investigational Site
Tamarac, Florida, United States
1218.75.015 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1218.75.103 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
1218.75.049 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1218.75.067 Boehringer Ingelheim Investigational Site
Calhoun, Georgia, United States
1218.75.016 Boehringer Ingelheim Investigational Site
Dunwoody, Georgia, United States
1218.75.063 Boehringer Ingelheim Investigational Site
Lawrenceville, Georgia, United States
1218.75.056 Boehringer Ingelheim Investigational Site
Marietta, Georgia, United States
1218.75.026 Boehringer Ingelheim Investigational Site
Rosswell, Georgia, United States
1218.75.079 Boehringer Ingelheim Investigational Site
Sandy Springs, Georgia, United States
1218.75.034 Boehringer Ingelheim Investigational Site
Snellville, Georgia, United States
1218.75.001 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1218.75.055 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1218.75.069 Boehringer Ingelheim Investigational Site
Owensboro, Kentucky, United States
1218.75.044 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1218.75.108 Boehringer Ingelheim Investigational Site
Essex, Maryland, United States
1218.75.086 Boehringer Ingelheim Investigational Site
Brockton, Massachusetts, United States
1218.75.087 Boehringer Ingelheim Investigational Site
Watertown, Massachusetts, United States
1218.75.051 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
1218.75.088 Boehringer Ingelheim Investigational Site
Flint, Michigan, United States
1218.75.099 Boehringer Ingelheim Investigational Site
Biloxi, Mississippi, United States
1218.75.006 Boehringer Ingelheim Investigational Site
Atco, New Jersey, United States
1218.75.004 Boehringer Ingelheim Investigational Site
Camden, New Jersey, United States
1218.75.031 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
1218.75.095 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
1218.75.038 Boehringer Ingelheim Investigational Site
Asheboro, 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
Charlotte, North Carolina, United States
1218.75.005 Boehringer Ingelheim Investigational Site
Greensboro, North Carolina, United States
1218.75.107 Boehringer Ingelheim Investigational Site
High Point, North Carolina, United States
1218.75.020 Boehringer Ingelheim Investigational Site
Jacksonville, North Carolina, United States
1218.75.027 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
1218.75.096 Boehringer Ingelheim Investigational Site
Akron, Ohio, United States
1218.75.090 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1218.75.078 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
1218.75.037 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1218.75.082 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1218.75.010 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania, United States
1218.75.028 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania, United States
1218.75.091 Boehringer Ingelheim Investigational Site
Anderson, South Carolina, United States
1218.75.072 Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
1218.75.068 Boehringer Ingelheim Investigational Site
Greenwood, South Carolina, United States
1218.75.097 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
1218.75.024 Boehringer Ingelheim Investigational Site
Brentwood, Tennessee, United States
1218.75.025 Boehringer Ingelheim Investigational Site
Collierville, Tennessee, United States
1218.75.011 Boehringer Ingelheim Investigational Site
Germantown, Tennessee, United States
1218.75.042 Boehringer Ingelheim Investigational Site
Humboldt, Tennessee, United States
1218.75.030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1218.75.050 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1218.75.053 Boehringer Ingelheim Investigational Site
Dallas, 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
Houston, Texas, United States
1218.75.043 Boehringer Ingelheim Investigational Site
Houton, Texas, United States
1218.75.022 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1218.75.058 Boehringer Ingelheim Investigational Site
Sugar Land, Texas, United States
1218.75.033 Boehringer Ingelheim Investigational Site
Tomball, Texas, United States
1218.75.102 Boehringer Ingelheim Investigational Site
Tomball, Texas, United States
1218.75.094 Boehringer Ingelheim Investigational Site
Waco, Texas, United States
1218.75.092 Boehringer Ingelheim Investigational Site
Whitney, Texas, United States
1218.75.019 Boehringer Ingelheim Investigational Site
Virgnia Beach, Virginia, United States
Countries
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References
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Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.
Thrasher J, Daniels K, Patel S, Whetteckey J. Black/African American patients with type 2 diabetes mellitus: study design and baseline patient characteristics from a randomized clinical trial of linagliptin. Expert Opin Pharmacother. 2012 Dec;13(17):2443-52. doi: 10.1517/14656566.2012.740459. Epub 2012 Nov 8.
Other Identifiers
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1218.75
Identifier Type: -
Identifier Source: org_study_id
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