NCT00954447CompletedPhase 3
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
Boehringer Ingelheim169 sites in 2 countries1,263 target enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,263
- Locations
- 169
- Primary Endpoint
- Change From Baseline in HbA1c After 24 Weeks
Study Overview
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin
Experimental
patient receives a tablet with intended final marketed dose
Intervention: Linagliptin (Drug)
Placebo
Placebo Comparator
patient receives a tablet identical to those containing Linagliptin
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in HbA1c After 24 Weeks
Time Frame: Baseline and 24 weeks
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Secondary Outcomes
- Number of Patients With HbA1c < 7.0 Percent(24 and 52 weeks)
- Number of Patients Lowering HbA1c by at Least 0.5 Percent(24 and 52 weeks)
- Change From Baseline in HbA1c by Visit at Week 6(Baseline and 6 weeks)
- Change From Baseline in HbA1c by Visit at Week 12(Baseline and 12 weeks)
- Change From Baseline in HbA1c by Visit at Week 18(Baseline and 18 weeks)
- Change From Baseline in HbA1c by Visit at Week 32(Baseline and 32 weeks)
- Change From Baseline in HbA1c by Visit at Week 40(Baseline and 40 weeks)
- Change From Baseline in HbA1c by Visit at Week 52(Baseline and 52 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment(Baseline and 24 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment(Baseline and 52 weeks)
- Change From Baseline in FPG(Baseline, 6, 12, 18, 24, 32 and 40 weeks)
- Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment(Baseline and 52 weeks)
- Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment(Baseline, 24 and 52 weeks)
- Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment(Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner)
Investigators
Study Sites (169)
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