A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Summary

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Conditions

• Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

empagliflozin (low dose qd)

Patients receive Empagliflozin low dose once daily

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

DRUG

Empagliflozin (high dose qd)

Patients receive Empagliflozin high dose once daily

DRUG

empagliflozin (high dose bid)

Patients receive Empagliflozin high dose split twice daily

DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

DRUG

empagliflozin (low dose bid)

Patients receive Empagliflozin low dose split twice daily

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• Boehringer Ingelheim

  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

2013-12-31

Completion

2013-12-31

Countries

• United States
• Australia
• Canada
• Estonia
• France
• Georgia
• Germany
• Guatemala
• Italy
• Latvia
• Lithuania
• Mexico
• New Zealand
• Poland
• Russia
• South Africa
• Spain
• Ukraine

Study Locations