A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 241
- Locations
- 52
- Primary Endpoint
- HbA1c Change From Baseline to Week 12
- Status
- Completed
- Last Updated
- 11 years ago
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 given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin
52 weeks treatment
Intervention: Placebo
Linagliptin
52 weeks treatment
Intervention: Linagliptin
Placebo
First 12 weeks of treatment
Intervention: Placebo
Glimepiride
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Intervention: Glimepiride
Glimepiride
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Intervention: Placebo
Outcomes
Primary Outcomes
HbA1c Change From Baseline to Week 12
Time Frame: Baseline and week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
Secondary Outcomes
- HbA1c Change From Baseline Over Time(Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52)
- Fasting Plasma Glucose (FPG) Change From Baseline to Week 12(Baseline and week 12)
- Fasting Plasma Glucose (FPG) Change From Baseline Over Time(Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52)
- Percentage of Patients With HbA1c <7.0%(Baseline, week 12 and week 52)
- Percentage of Patients With HbA1c <6.5%(Baseline, week 12 and week 52)
- Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%(Baseline, week 12 and week 52)
- Plasma Concentration of Linagliptin at Trough(Week 12, 24 and 52)