A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Overview
- Phase
- Phase 3
- Intervention
- voglibose
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 561
- Locations
- 47
- Primary Endpoint
- Change From Baseline in HbA1c at Week 12
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
voglibose 0.2 mg three times a day (TID)
patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
Intervention: voglibose
BI 1356 low dose
patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
Intervention: BI 1356
BI 1356 high dose
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
Intervention: BI 1356
placebo
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
Intervention: voglibose placebo
placebo
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
Intervention: BI 1356 placebo
Outcomes
Primary Outcomes
Change From Baseline in HbA1c at Week 12
Time Frame: 12 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in HbA1c at Week 26
Time Frame: 26 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Time Frame: 52 weeks
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12(12 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26(26 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52(52 weeks)
- Relative Efficacy Response of HbA1c at Week 12(12 weeks)
- Relative Efficacy Response of HbA1c at Week 26(26 weeks)
- Relative Efficacy Response of HbA1c at Week 52(52 weeks)