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

June 26, 2015 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

983

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia
        • 1276.10.61002 Boehringer Ingelheim Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia
        • 1276.10.61001 Boehringer Ingelheim Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1276.10.20008 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada
        • 1276.10.20005 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1276.10.20010 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Bathurst, New Brunswick, Canada
        • 1276.10.20002 Boehringer Ingelheim Investigational Site
    • Ontario
      • Brampton, Ontario, Canada
        • 1276.10.20001 Boehringer Ingelheim Investigational Site
      • Corunna, Ontario, Canada
        • 1276.10.20007 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1276.10.20006 Boehringer Ingelheim Investigational Site
    • Quebec
      • Drummondville, Quebec, Canada
        • 1276.10.20004 Boehringer Ingelheim Investigational Site
      • Point Claire, Quebec, Canada
        • 1276.10.20003 Boehringer Ingelheim Investigational Site
      • Victoriaville, Quebec, Canada
        • 1276.10.20009 Boehringer Ingelheim Investigational Site
  • Estonia
      • Pärnu, Estonia
        • 1276.10.37203 Boehringer Ingelheim Investigational Site
      • Tallinn, Estonia
        • 1276.10.37201 Boehringer Ingelheim Investigational Site
      • Tallinn, Estonia
        • 1276.10.37202 Boehringer Ingelheim Investigational Site
      • Viljandi County, Estonia
        • 1276.10.37204 Boehringer Ingelheim Investigational Site
  • France
      • Aire sur l'Adour, France
        • 1276.10.33002 Boehringer Ingelheim Investigational Site
      • Bischheim, France
        • 1276.10.33003 Boehringer Ingelheim Investigational Site
      • Bourg des Comptes, France
        • 1276.10.33009 Boehringer Ingelheim Investigational Site
      • Bourges, France
        • 1276.10.33014 Boehringer Ingelheim Investigational Site
      • Broglie, France
        • 1276.10.33007 Boehringer Ingelheim Investigational Site
      • Mont de Marsan, France
        • 1276.10.33001 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1276.10.33008 Boehringer Ingelheim Investigational Site
      • Saint Vinecnt de Tyrosse, France
        • 1276.10.33006 Boehringer Ingelheim Investigational Site
      • Segre, France
        • 1276.10.33011 Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1276.10.33004 Boehringer Ingelheim Investigational Site
  • Georgia
      • Tbilisi, Georgia
        • 1276.10.99501 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1276.10.99502 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1276.10.99503 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1276.10.99504 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1276.10.99505 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1276.10.99506 Boehringer Ingelheim Investigational Site
  • Germany
      • Aschaffenburg, Germany
        • 1276.10.49001 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1276.10.49006 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1276.10.49007 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1276.10.49005 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 1276.10.49004 Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • 1276.10.49002 Boehringer Ingelheim Investigational Site
      • Rehlingen-Siersburg, Germany
        • 1276.10.49003 Boehringer Ingelheim Investigational Site
  • Guatemala
      • Guatemala Ciudad, Guatemala
        • 1276.10.50201 Boehringer Ingelheim Investigational Site
      • Guatemala Ciudad, Guatemala
        • 1276.10.50203 Boehringer Ingelheim Investigational Site
      • Guatemala Ciudad, Guatemala
        • 1276.10.50204 Boehringer Ingelheim Investigational Site
      • Guatemala Ciudad, Guatemala
        • 1276.10.50205 Boehringer Ingelheim Investigational Site
      • Quetzaltenango Ciudad, Guatemala
        • 1276.10.50202 Boehringer Ingelheim Investigational Site
  • Italy
      • Arenzano (GE), Italy
        • 1276.10.39004 Boehringer Ingelheim Investigational Site
      • Bologna, Italy
        • 1276.10.39003 Boehringer Ingelheim Investigational Site
      • Catanzaro, Italy
        • 1276.10.39007 Boehringer Ingelheim Investigational Site
      • Catanzaro, Italy
        • 1276.10.39009 Boehringer Ingelheim Investigational Site
      • Napoli, Italy
        • 1276.10.39002 Boehringer Ingelheim Investigational Site
      • Palermo, Italy
        • 1276.10.39006 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1276.10.39001 Boehringer Ingelheim Investigational Site
      • Roma, Italy
        • 1276.10.39008 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 1276.10.39005 Boehringer Ingelheim Investigational Site
  • Latvia
      • Daugavpils, Latvia
        • 1276.10.37102 Boehringer Ingelheim Investigational Site
      • Ogre, Latvia
        • 1276.10.37104 Boehringer Ingelheim Investigational Site
      • Riga, Latvia
        • 1276.10.37101 Boehringer Ingelheim Investigational Site
      • Tukums, Latvia
        • 1276.10.37103 Boehringer Ingelheim Investigational Site
  • Lithuania
      • Kaunas, Lithuania
        • 1276.10.37003 Boehringer Ingelheim Investigational Site
      • Kaunas, Lithuania
        • 1276.10.37004 Boehringer Ingelheim Investigational Site
      • Klaipeda, Lithuania
        • 1276.10.37002 Boehringer Ingelheim Investigational Site
      • Vilnius, Lithuania
        • 1276.10.37001 Boehringer Ingelheim Investigational Site
  • Mexico
      • Ciudad de Mexico, Mexico
        • 1276.10.52001 Boehringer Ingelheim Investigational Site
      • Ciudad de Mexico, Mexico
        • 1276.10.52002 Boehringer Ingelheim Investigational Site
      • Durango, Mexico
        • 1276.10.52003 Boehringer Ingelheim Investigational Site
      • Pachuca, Mexico
        • 1276.10.52005 Boehringer Ingelheim Investigational Site
      • Tijuana, Mexico
        • 1276.10.52004 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1276.10.64001 Boehringer Ingelheim Investigational Site
      • Greenlane East Auckland NZ, New Zealand
        • 1276.10.64002 Boehringer Ingelheim Investigational Site
  • Poland
      • Bialystok, Poland
        • 1276.10.48001 Boehringer Ingelheim Investigational Site
      • Bialystok, Poland
        • 1276.10.48002 Boehringer Ingelheim Investigational Site
      • Gizycko, Poland
        • 1276.10.48008 Boehringer Ingelheim Investigational Site
      • Katowice, Poland
        • 1276.10.48005 Boehringer Ingelheim Investigational Site
      • Katowice, Poland
        • 1276.10.48006 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 1276.10.48004 Boehringer Ingelheim Investigational Site
      • Warszawa, Poland
        • 1276.10.48003 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1276.10.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1276.10.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1276.10.70003 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1276.10.70004 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1276.10.70005 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1276.10.70007 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1276.10.70008 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1276.10.70009 Boehringer Ingelheim Investigational Site
  • South Africa
      • Paarl, South Africa
        • 1276.10.27004 Boehringer Ingelheim Investigational Site
      • Parow, South Africa
        • 1276.10.27003 Boehringer Ingelheim Investigational Site
      • Plumstead, Cape Town, South Africa
        • 1276.10.27006 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1276.10.27001 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1276.10.27005 Boehringer Ingelheim Investigational Site
      • Somerset West, South Africa
        • 1276.10.27002 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1276.10.34005 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spain
        • 1276.10.34001 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spain
        • 1276.10.34003 Boehringer Ingelheim Investigational Site
      • Les Borges del Camp, Spain
        • 1276.10.34002 Boehringer Ingelheim Investigational Site
      • Sant Adria del Besos, Spain
        • 1276.10.34004 Boehringer Ingelheim Investigational Site
      • Vic, Spain
        • 1276.10.34006 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkiv, Ukraine
        • 1276.10.38002 Boehringer Ingelheim Investigational Site
      • Kharkiv, Ukraine
        • 1276.10.38007 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1276.10.38001 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1276.10.38004 Boehringer Ingelheim Investigational Site
      • Kyiv, Ukraine
        • 1276.10.38005 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Florence, Alabama, United States
        • 1276.10.11036 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • 1276.10.11049 Boehringer Ingelheim Investigational Site
    • California
      • Lomita, California, United States
        • 1276.10.11040 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1276.10.11033 Boehringer Ingelheim Investigational Site
      • Rancho Cucamonga, California, United States
        • 1276.10.11002 Boehringer Ingelheim Investigational Site
      • Sacramento, California, United States
        • 1276.10.11050 Boehringer Ingelheim Investigational Site
      • West Hills, California, United States
        • 1276.10.11015 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States
        • 1276.10.11012 Boehringer Ingelheim Investigational Site
      • Waterbury, Connecticut, United States
        • 1276.10.11047 Boehringer Ingelheim Investigational Site
    • Florida
      • Bradenton, Florida, United States
        • 1276.10.11010 Boehringer Ingelheim Investigational Site
      • Davie, Florida, United States
        • 1276.10.11005 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, United States
        • 1276.10.11004 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1276.10.11051 Boehringer Ingelheim Investigational Site
      • Oakland Park, Florida, United States
        • 1276.10.11009 Boehringer Ingelheim Investigational Site
      • Palm Harbor, Florida, United States
        • 1276.10.11044 Boehringer Ingelheim Investigational Site
    • Georgia
      • Dunwoody, Georgia, United States
        • 1276.10.11030 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1276.10.11027 Boehringer Ingelheim Investigational Site
    • Indiana
      • Elwood, Indiana, United States
        • 1276.10.11020 Boehringer Ingelheim Investigational Site
    • Maine
      • Bangor, Maine, United States
        • 1276.10.11001 Boehringer Ingelheim Investigational Site
    • Michigan
      • Sterling Heights, Michigan, United States
        • 1276.10.11048 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States
        • 1276.10.11058 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Edison, New Jersey, United States
        • 1276.10.11055 Boehringer Ingelheim Investigational Site
    • New York
      • Brooklyn, New York, United States
        • 1276.10.11011 Boehringer Ingelheim Investigational Site
    • North Carolina
      • North Myrtle Beach, North Carolina, United States
        • 1276.10.11035 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 1276.10.11041 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1276.10.11018 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 1276.10.11043 Boehringer Ingelheim Investigational Site
      • Kettering, Ohio, United States
        • 1276.10.11017 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States
        • 1276.10.11022 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States
        • 1276.10.11003 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, United States
        • 1276.10.11042 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1276.10.11013 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1276.10.11026 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1276.10.11031 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1276.10.11034 Boehringer Ingelheim Investigational Site
      • Pearland, Texas, United States
        • 1276.10.11028 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1276.10.11029 Boehringer Ingelheim Investigational Site
    • Washington
      • Port Orchard, Washington, United States
        • 1276.10.11016 Boehringer Ingelheim Investigational Site
      • Spokane, Washington, United States
        • 1276.10.11024 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: empagliflozin (high dose qd)
Patients receive Empagliflozin high 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 qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
Experimental: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice 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 qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
Experimental: 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 qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
Experimental: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice 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 qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
Placebo Comparator: Placebo
Patients receive placebo matching Empagliflozin
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 bid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Time Frame: Baseline and 16 weeks

Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.

Means provided are the adjusted means.
Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Time Frame: Baseline and 16 weeks

Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.

Means provided are the adjusted means.
Baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1276.10
  • 2012-000905-53 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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