Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
NCT01719003 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1413
Last updated 2016-02-19
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.
Conditions
- Diabetes Mellitus, Type 2
- Hyperglycemia
Interventions
- DRUG
-
Metformin 500 mg bid
Metformin 500 mg twice daily
- DRUG
-
Metformin 1000 mg bid
Metformin 1000 mg twice daily
- DRUG
-
Empagliflozin low dose qd
Empagliflozin low dose once daily
- DRUG
-
Empagliflozin high dose qd
Empagliflozin high dose once daily
- DRUG
-
Empagliflozin low dose bid
Empagliflozin low dose split twice daily
- DRUG
-
Metformin 500 mg bid
Metformin 500 mg twice daily
- DRUG
-
Empagliflozin high dose bid
Empagliflozin high dose split twice daily
- DRUG
-
Empagliflozin low dose bid
Empagliflozin low dose split twice daily
- DRUG
-
Metformin 1000 mg bid
Metformin 1000 mg twice daily
- DRUG
-
Metformin 500 mg bid
Metformin 500 mg twice daily
- DRUG
-
Metformin 1000 mg bid
Metformin 1000 mg twice daily
- DRUG
-
Empagliflozin high dose bid
Empagliflozin high dose split twice daily
- DRUG
-
Metformin 1000 mg bid
Metformin 1000 mg twice daily
- DRUG
-
Empagliflozin high dose bid
Empagliflozin high dose split twice daily
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2014-11-30
- Completion
- 2014-12-31
Countries
- United States
- Brazil
- Canada
- Czechia
- Egypt
- France
- Germany
- Guatemala
- Lebanon
- Malaysia
- Mexico
- Peru
- Philippines
- Russia
- Serbia
- South Korea
- Spain
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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