A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,413
- Locations
- 190
- Primary Endpoint
- HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Study Overview
Brief Summary
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.
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
Empagliflozin low dose qd
Empagliflozin low dose once daily
Intervention: Empagliflozin low dose qd (Drug)
Empagliflozin high dose qd
Empagliflozin high dose once daily
Intervention: Empagliflozin high dose qd (Drug)
OL empa high dose + met 1000 mg bid
Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
Intervention: Metformin 1000 mg bid (Drug)
OL empa high dose + met 1000 mg bid
Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
Intervention: Empagliflozin high dose bid (Drug)
Empagliflozin low dose + met 500 mg bid
Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Intervention: Metformin 500 mg bid (Drug)
Empagliflozin low dose + met 500 mg bid
Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Intervention: Empagliflozin low dose bid (Drug)
Empagliflozin low dose + met 1000 mg bid
Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
Intervention: Empagliflozin low dose bid (Drug)
Empagliflozin low dose + met 1000 mg bid
Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
Intervention: Metformin 1000 mg bid (Drug)
Empagliflozin high dose + met 500 mg bid
Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Intervention: Metformin 500 mg bid (Drug)
Empagliflozin high dose + met 500 mg bid
Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Intervention: Empagliflozin high dose bid (Drug)
Empagliflozin high dose + met 1000mg bid
Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Intervention: Metformin 1000 mg bid (Drug)
Empagliflozin high dose + met 1000mg bid
Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Intervention: Empagliflozin high dose bid (Drug)
Metformin 500 mg bid
Metformin 500 mg twice daily
Intervention: Metformin 500 mg bid (Drug)
Metformin 1000 mg bid
Metformin 1000 mg twice daily
Intervention: Metformin 1000 mg bid (Drug)
Outcomes
Primary Outcomes
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Time Frame: baseline and 24 weeks
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
Secondary Outcomes
- FPG (Fasting Plasma Glucose) Change From Baseline at Week 24(baseline and 24 weeks)
- Body Weight Change From Baseline at Week 24(baseline and 24 weeks)