A Phase III, Randomised, Double-blind, Parallel Group, 52 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin and Linagliptin Fixed Dose Combination Compared With Linagliptin Plus Placebo in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control After 16 Weeks Treatment With Once Daily Linagliptin 5 mg.
Overview
- Phase
- Phase 3
- Intervention
- Linagliptin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 275
- Locations
- 40
- Primary Endpoint
- Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin
patient to receive 5 mg linagliptin once daily
Intervention: Linagliptin
Linagliptin
patient to receive 5 mg linagliptin once daily
Intervention: Empagliflozin placebo + linagliptin placebo low dose
Linagliptin
patient to receive 5 mg linagliptin once daily
Intervention: Empa + lina highdose placebo
Empagliflozin + linagliptin low dose
patient to receive one tablet once daily
Intervention: Empagliflozin + linagliptin low dose
Empagliflozin + linagliptin low dose
patient to receive one tablet once daily
Intervention: Linagliptin placebo
Empagliflozin + linagliptin high dose
patient to receive one tablet once daily
Intervention: Linagliptin placebo
Empagliflozin + linagliptin high dose
patient to receive one tablet once daily
Intervention: Empagliflozin + linagliptin high dose
Linagliptin placebo
Intervention: Empagliflozin + linagliptin low dose
Linagliptin placebo
Intervention: Linagliptin placebo
Linagliptin placebo
Intervention: Empagliflozin + linagliptin high dose
Empagliflozin + linagliptin high dose placebo
Intervention: Linagliptin
Empagliflozin + linagliptin high dose placebo
Intervention: Empa + lina highdose placebo
Empagliflozin + linagliptin low dose placebo
Intervention: Linagliptin
Empagliflozin + linagliptin low dose placebo
Intervention: Empagliflozin placebo + linagliptin placebo low dose
Outcomes
Primary Outcomes
Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
Time Frame: Baseline and 24 week
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Secondary Outcomes
- Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only)(28 Week (pre up-titration) and 52 Week)
- Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo)(Baseline and 52 week)
- Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg)(Baseline and 52 week)
- Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo)(Baseline and 52 week)