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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: empagliflozin (low dose qd)
Drug: Empagliflozin (high dose qd)
Drug: empagliflozin (high dose bid)
Drug: empagliflozin (low dose bid)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in glycated hemoglobin from baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose from baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 983
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (high dose bid)
Drug: Placebo
Patients receive placebo matching empagliflozin (low 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 (high dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low 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: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
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 qd)
Experimental: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low 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 bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649297

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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01649297     History of Changes
Other Study ID Numbers: 1276.10, 2012-000905-53
Study First Received: July 23, 2012
Last Updated: March 27, 2014
Health Authority: Australia: Human Research Ethics Committee
Canada: Health Canada
Estonia: The State Agency of Medicine
France: Agence Nationale sécurité médicament et des produits santé
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Public Health and Social Assistance
Italy: Ethics Committee
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
New Zealand: Health and Disability Ethics Committees
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014