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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

NCT01649297•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. confirmed diagnosis of T2DM
•2. Glycated hemoglobin (HbA1c) \>=7.0 and \<=10/0% at Visit 1
•3. Metformin therapy (at least 1500 mg/day, BID)
•4. age\>=18 at Visit 1
•5. body mass index \<=45 kg/m2

Exclusion Criteria

•1. estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) screening and/or run-in
•2. a confirmed glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in

Locations (139)

1276.10.11036 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

1276.10.11049 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

1276.10.11040 Boehringer Ingelheim Investigational Site

Lomita, California, United States

1276.10.11033 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1276.10.11002 Boehringer Ingelheim Investigational Site

Rancho Cucamonga, California, United States

1276.10.11050 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

1276.10.11015 Boehringer Ingelheim Investigational Site

West Hills, California, United States

1276.10.11012 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

1276.10.11047 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

1276.10.11010 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Key Dates

Start Date

October 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

July 23, 2015

Enrollment

983

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

empagliflozin (low dose qd)

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Empagliflozin (high dose qd)

DRUG

empagliflozin (high dose bid)

DRUG

Placebo

DRUG

empagliflozin (low dose bid)

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)