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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Linagliptin; Drug: Placebo

• Registration Number: NCT01194830
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-09-26
• Results First Submitted QC: 2012-09-26
• Results First Posted: 2012-10-26
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin	Linagliptin	1 Tablet PO QD
Placebo	Placebo	1 Tablet PO QD

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks	baseline, 24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks	baseline, 6 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks	baseline, 12 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks	baseline, 18 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks	24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks	24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks	24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks	baseline, 24 weeks
Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks	baseline, 24 weeks

Trial Locations

Locations (93)

1218.75.053 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1218.75.102 Boehringer Ingelheim Investigational Site; 🇺🇸 Tomball, Texas, United States

1218.75.037 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

1218.75.033 Boehringer Ingelheim Investigational Site; 🇺🇸 Tomball, Texas, United States

1218.75.049 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

1218.75.055 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

1218.75.090 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, 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

1218.75.029 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.75.084 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.75.022 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1218.75.035 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

1218.75.054 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

1218.75.001 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

1218.75.051 Boehringer Ingelheim Investigational Site; 🇺🇸 Detroit, Michigan, United States

1218.75.059 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1218.75.101 Boehringer Ingelheim Investigational Site; 🇺🇸 Toney, Alabama, United States

1218.75.047 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1218.75.075 Boehringer Ingelheim Investigational Site; 🇺🇸 Tallahassee, 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

1218.75.071 Boehringer Ingelheim Investigational Site; 🇺🇸 Anaheim, 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

1218.75.018 Boehringer Ingelheim Investigational Site; 🇺🇸 Chino, California, United States

1218.75.040 Boehringer Ingelheim Investigational Site; 🇺🇸 Colorado Springs, 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

1218.75.080 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, Florida, United States

1218.75.002 Boehringer Ingelheim Investigational Site; 🇺🇸 Hialeah, Florida, United States

1218.75.083 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Myers, 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

1218.75.045 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

1218.75.100 Boehringer Ingelheim Investigational Site; 🇺🇸 Tamarac, Florida, United States

1218.75.003 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Petersburg, 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

1218.75.067 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

1218.75.034 Boehringer Ingelheim Investigational Site; 🇺🇸 Snellville, 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

1218.75.069 Boehringer Ingelheim Investigational Site; 🇺🇸 Owensboro, Kentucky, United States

1218.75.086 Boehringer Ingelheim Investigational Site; 🇺🇸 Brockton, Massachusetts, United States

1218.75.108 Boehringer Ingelheim Investigational Site; 🇺🇸 Essex, Maryland, United States

1218.75.006 Boehringer Ingelheim Investigational Site; 🇺🇸 Atco, New Jersey, United States

1218.75.099 Boehringer Ingelheim Investigational Site; 🇺🇸 Biloxi, Mississippi, United States

1218.75.004 Boehringer Ingelheim Investigational Site; 🇺🇸 Camden, New Jersey, United States

1218.75.095 Boehringer Ingelheim Investigational Site; 🇺🇸 Brooklyn, New York, United States

1218.75.009 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

1218.75.038 Boehringer Ingelheim Investigational Site; 🇺🇸 Asheboro, North Carolina, United States

1218.75.023 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

1218.75.107 Boehringer Ingelheim Investigational Site; 🇺🇸 High Point, 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

1218.75.020 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

1218.75.078 Boehringer Ingelheim Investigational Site; 🇺🇸 Dayton, Ohio, United States

1218.75.082 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

1218.75.010 Boehringer Ingelheim Investigational Site; 🇺🇸 Uniontown, Pennsylvania, United States

1218.75.091 Boehringer Ingelheim Investigational Site; 🇺🇸 Anderson, South Carolina, United States

1218.75.097 Boehringer Ingelheim Investigational Site; 🇺🇸 Greer, South Carolina, United States

1218.75.068 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenwood, South Carolina, United States

1218.75.025 Boehringer Ingelheim Investigational Site; 🇺🇸 Collierville, 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

1218.75.043 Boehringer Ingelheim Investigational Site; 🇺🇸 Houton, Texas, United States

1218.75.058 Boehringer Ingelheim Investigational Site; 🇺🇸 Sugar Land, Texas, United States

1218.75.094 Boehringer Ingelheim Investigational Site; 🇺🇸 Waco, Texas, United States

1218.75.019 Boehringer Ingelheim Investigational Site; 🇺🇸 Virgnia Beach, Virginia, United States

1218.75.092 Boehringer Ingelheim Investigational Site; 🇺🇸 Whitney, Texas, United States

1218.75.088 Boehringer Ingelheim Investigational Site; 🇺🇸 Flint, Michigan, United States

1218.75.039 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Petersburg, Florida, United States

1218.75.087 Boehringer Ingelheim Investigational Site; 🇺🇸 Watertown, Massachusetts, United States

1218.75.031 Boehringer Ingelheim Investigational Site; 🇺🇸 Brooklyn, New York, United States

1218.75.028 Boehringer Ingelheim Investigational Site; 🇺🇸 Uniontown, Pennsylvania, United States

1218.75.008 Boehringer Ingelheim Investigational Site; 🇺🇸 Pell City, Alaska, United States

1218.75.072 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbia, South Carolina, United States

1218.75.066 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Alaska, United States

1218.75.044 Boehringer Ingelheim Investigational Site; 🇺🇸 Baton Rouge, Louisiana, United States

1218.75.024 Boehringer Ingelheim Investigational Site; 🇺🇸 Brentwood, Tennessee, United States

1218.75.011 Boehringer Ingelheim Investigational Site; 🇺🇸 Germantown, Tennessee, United States