NCT01719003

Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,413 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2012-11-01
• Last updated: 2016-02-19
• Results posted: 2016-02-19

Locations

190 sites across 21 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