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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Hyperglycemia
• Interventions: Drug: Metformin 500 mg bid; Drug: Empagliflozin low dose bid; Drug: Metformin 1000 mg bid; Drug: Empagliflozin low dose qd; Drug: Empagliflozin high dose qd; Drug: Empagliflozin high dose bid

• Registration Number: NCT01719003
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Results First Submitted: 2015-11-23
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Results First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1413

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin high dose + met 1000mg bid	Empagliflozin high dose bid	Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Empagliflozin high dose + met 500 mg bid	Metformin 500 mg bid	Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Empagliflozin low dose + met 1000 mg bid	Empagliflozin low dose bid	Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
OL empa high dose + met 1000 mg bid	Empagliflozin high dose 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.
OL empa high dose + met 1000 mg bid	Metformin 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.
Empagliflozin low dose + met 1000 mg bid	Metformin 1000 mg bid	Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
Empagliflozin low dose + met 500 mg bid	Metformin 500 mg bid	Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Empagliflozin high dose + met 1000mg bid	Metformin 1000 mg bid	Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Metformin 500 mg bid	Metformin 500 mg bid	Metformin 500 mg twice daily
Empagliflozin low dose qd	Empagliflozin low dose qd	Empagliflozin low dose once daily
Empagliflozin high dose qd	Empagliflozin high dose qd	Empagliflozin high dose once daily
Empagliflozin low dose + met 500 mg bid	Empagliflozin low dose bid	Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Empagliflozin high dose + met 500 mg bid	Empagliflozin high dose bid	Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Metformin 1000 mg bid	Metformin 1000 mg bid	Metformin 1000 mg twice daily

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24	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 Outcome Measures

Name	Time	Method
FPG (Fasting Plasma Glucose) Change From Baseline at Week 24	baseline and 24 weeks	Change from baseline in FPG (mg/dL) 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.
Body Weight Change From Baseline at Week 24	baseline and 24 weeks	Change from baseline in body weight (kg) 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.

Trial Locations

Locations (190)

1276.1.10014 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1276.1.10019 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1276.1.10044 Boehringer Ingelheim Investigational Site; 🇺🇸 Hot Springs, Alaska, United States

1276.1.10010 Boehringer Ingelheim Investigational Site; 🇺🇸 Glendale, Arizona, United States

1276.1.10035 Boehringer Ingelheim Investigational Site; 🇺🇸 Searcy, Arkansas, United States

1276.1.10046 Boehringer Ingelheim Investigational Site; 🇺🇸 Chula Vista, California, United States

1276.1.10006 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Beach, California, United States

1276.1.10043 Boehringer Ingelheim Investigational Site; 🇺🇸 La Mesa, California, United States

1276.1.10009 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1276.1.10040 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

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