Clinical trial NCT01194830: Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-09-03
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
timeFrame: baseline, 6 weeks
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
timeFrame: baseline, 18 weeks
measure: Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
timeFrame: 24 weeks
measure: Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
timeFrame: 24 weeks
measure: Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
timeFrame: 24 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
timeFrame: baseline, 24 weeks
measure: Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks
timeFrame: baseline, 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1218.75.059 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 1218.75.054 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1218.75.035 Boehringer Ingelheim Investigational Site
state: Alabama
city: Toney
country: United States
facility: 1218.75.101 Boehringer Ingelheim Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: 1218.75.066 Boehringer Ingelheim Investigational Site
state: Alaska
city: Pell City
country: United States
facility: 1218.75.008 Boehringer Ingelheim Investigational Site
state: Alaska
city: Anaheim
country: United States
facility: 1218.75.071 Boehringer Ingelheim Investigational Site
state: California
city: Chino
country: United States
facility: 1218.75.018 Boehringer Ingelheim Investigational Site
state: California
city: Garden Grove
country: United States
facility: 1218.75.081 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1218.75.109 Boehringer Ingelheim Investigational Site
state: California
city: Colorado Springs
country: United States
facility: 1218.75.040 Boehringer Ingelheim Investigational Site
state: Colorado
city: Denver
country: United States
facility: 1218.75.047 Boehringer Ingelheim Investigational Site
state: Colorado
city: Bartow
country: United States
facility: 1218.75.106 Boehringer Ingelheim Investigational Site
state: Florida
city: Bradenton
country: United States
facility: 1218.75.098 Boehringer Ingelheim Investigational Site
state: Florida
city: Chiefland
country: United States
facility: 1218.75.036 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 1218.75.105 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: 1218.75.083 Boehringer Ingelheim Investigational Site
state: Florida
city: Hialeah
country: United States
facility: 1218.75.002 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1218.75.080 Boehringer Ingelheim Investigational Site
state: Florida
city: Jupiter
country: United States
facility: 1218.75.065 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1218.75.007 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1218.75.029 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1218.75.045 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1218.75.084 Boehringer Ingelheim Investigational Site
state: Florida
city: Ocala
country: United States
facility: 1218.75.017 Boehringer Ingelheim Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: 1218.75.012 Boehringer Ingelheim Investigational Site
state: Florida
city: Port Orange
country: United States
facility: 1218.75.074 Boehringer Ingelheim Investigational Site
state: Florida
city: South Miami
country: United States
facility: 1218.75.076 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 1218.75.003 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 1218.75.039 Boehringer Ingelheim Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: 1218.75.075 Boehringer Ingelheim Investigational Site
state: Florida
city: Tamarac
country: United States
facility: 1218.75.100 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1218.75.015 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 1218.75.103 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1218.75.049 Boehringer Ingelheim Investigational Site
state: Georgia
city: Calhoun
country: United States
facility: 1218.75.067 Boehringer Ingelheim Investigational Site
state: Georgia
city: Dunwoody
country: United States
facility: 1218.75.016 Boehringer Ingelheim Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: 1218.75.063 Boehringer Ingelheim Investigational Site
state: Georgia
city: Marietta
country: United States
facility: 1218.75.056 Boehringer Ingelheim Investigational Site
state: Georgia
city: Rosswell
country: United States
facility: 1218.75.026 Boehringer Ingelheim Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: 1218.75.079 Boehringer Ingelheim Investigational Site
state: Georgia
city: Snellville
country: United States
facility: 1218.75.034 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1218.75.001 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1218.75.055 Boehringer Ingelheim Investigational Site
state: Illinois
city: Owensboro
country: United States
facility: 1218.75.069 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: 1218.75.044 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Essex
country: United States
facility: 1218.75.108 Boehringer Ingelheim Investigational Site
state: Maryland
city: Brockton
country: United States
facility: 1218.75.086 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: 1218.75.087 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: 1218.75.051 Boehringer Ingelheim Investigational Site
state: Michigan
city: Flint
country: United States
facility: 1218.75.088 Boehringer Ingelheim Investigational Site
state: Michigan
city: Biloxi
country: United States
facility: 1218.75.099 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Atco
country: United States
facility: 1218.75.006 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Camden
country: United States
facility: 1218.75.004 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: 1218.75.031 Boehringer Ingelheim Investigational Site
state: New York
city: Brooklyn
country: United States
facility: 1218.75.095 Boehringer Ingelheim Investigational Site
state: New York
city: Asheboro
country: United States
facility: 1218.75.038 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 1218.75.009 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 1218.75.023 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 1218.75.060 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: 1218.75.005 Boehringer Ingelheim Investigational Site
state: North Carolina
city: High Point
country: United States
facility: 1218.75.107 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Jacksonville
country: United States
facility: 1218.75.020 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: 1218.75.027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: 1218.75.096 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1218.75.090 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 1218.75.078 Boehringer Ingelheim Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: 1218.75.037 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1218.75.082 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: 1218.75.010 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: 1218.75.028 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: 1218.75.091 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: 1218.75.072 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenwood
country: United States
facility: 1218.75.068 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greer
country: United States
facility: 1218.75.097 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Brentwood
country: United States
facility: 1218.75.024 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Collierville
country: United States
facility: 1218.75.025 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: 1218.75.011 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Humboldt
country: United States
facility: 1218.75.042 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 1218.75.030 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 1218.75.050 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: 1218.75.053 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.75.057 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.75.064 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.75.104 Boehringer Ingelheim Investigational Site
state: Texas
city: Houton
country: United States
facility: 1218.75.043 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1218.75.022 Boehringer Ingelheim Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: 1218.75.058 Boehringer Ingelheim Investigational Site
state: Texas
city: Tomball
country: United States
facility: 1218.75.033 Boehringer Ingelheim Investigational Site
state: Texas
city: Tomball
country: United States
facility: 1218.75.102 Boehringer Ingelheim Investigational Site
state: Texas
city: Waco
country: United States
facility: 1218.75.094 Boehringer Ingelheim Investigational Site
state: Texas
city: Whitney
country: United States
facility: 1218.75.092 Boehringer Ingelheim Investigational Site
state: Texas
city: Virgnia Beach
country: United States
facility: 1218.75.019 Boehringer Ingelheim Investigational Site
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.