Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
234
Active drug 1 tablet PO QD
1 Tablet PO QD
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 24 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 6 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 12 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 18 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: 24 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: 24 weeks
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: 24 weeks
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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
...and 83 more locations
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
Time frame: baseline, 24 weeks
Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks
Time frame: baseline, 24 weeks