A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.
Overview
- Phase
- Phase 3
- Intervention
- Linagliptin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 607
- Locations
- 90
- Primary Endpoint
- HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Linagliptin
5 mg once daily
Intervention: Linagliptin
Linagliptin
5 mg once daily
Intervention: Empagliflozin placebo + Linagliptin placebo
Empagliflozin + Linagliptin low dose
1 tablet once daily
Intervention: Empagliflozin + Linagliptin
Empagliflozin + Linagliptin high dose
1 tablet once daily
Intervention: Empagliflozin + Linagliptin
Outcomes
Primary Outcomes
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Time Frame: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
Secondary Outcomes
- Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment(Baseline and 24 weeks)
- Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.(Baseline and 24 weeks)