NCT01194830CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 234
- Locations
- 93
- Primary Endpoint
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Study Overview
Brief Summary
Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin
Active Comparator
1 Tablet PO QD
Intervention: Linagliptin (Drug)
Placebo
Placebo Comparator
1 Tablet PO QD
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Time Frame: baseline, 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Secondary Outcomes
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks(baseline, 6 weeks)
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks(baseline, 12 weeks)
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks(baseline, 18 weeks)
- Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks(24 weeks)
- Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks(24 weeks)
- Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks(24 weeks)
- 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)
Investigators
Study Sites (93)
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