Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: BI 10773; Drug: Placebo; Drug: Glimepiride

• Study Type: Interventional
• Enrollment (Actual): 1549
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • 1245.28.54010 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1245.28.54001 Boehringer Ingelheim Investigational Site
  • Córdoba, Argentina
    • 1245.28.54002 Boehringer Ingelheim Investigational Site
  • Córdoba, Argentina
    • 1245.28.54003 Boehringer Ingelheim Investigational Site
• Austria
  • Graz, Austria
    • 1245.28.43006 Boehringer Ingelheim Investigational Site
  • Salzburg, Austria
    • 1245.28.43005 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.28.43001 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.28.43002 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.28.43003 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1245.28.43004 Boehringer Ingelheim Investigational Site
• Canada
  • Quebec, Canada
    • 1245.28.20076 Boehringer Ingelheim Investigational Site
  • Alberta
    • Calgary, Alberta, Canada
      • 1245.28.20074 Boehringer Ingelheim Investigational Site
    • Calgary, Alberta, Canada
      • 1245.28.20077 Boehringer Ingelheim Investigational Site
    • Edmonton, Alberta, Canada
      • 1245.28.20075 Boehringer Ingelheim Investigational Site
  • British Columbia
    • Langley, British Columbia, Canada
      • 1245.28.20084 Boehringer Ingelheim Investigational Site
  • Newfoundland and Labrador
    • Grand Falls-Windsor, Newfoundland and Labrador, Canada
      • 1245.28.20082 Boehringer Ingelheim Investigational Site
    • Mount Pearl, Newfoundland and Labrador, Canada
      • 1245.28.20016 Boehringer Ingelheim Investigational Site
    • St. John's, Newfoundland and Labrador, Canada
      • 1245.28.20079 Boehringer Ingelheim Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • 1245.28.20071 Boehringer Ingelheim Investigational Site
  • Ontario
    • Collingwood, Ontario, Canada
      • 1245.28.20080 Boehringer Ingelheim Investigational Site
    • Stayner, Ontario, Canada
      • 1245.28.20078 Boehringer Ingelheim Investigational Site
    • Strathroy, Ontario, Canada
      • 1245.28.20005 Boehringer Ingelheim Investigational Site
    • Sudbury, Ontario, Canada
      • 1245.28.20083 Boehringer Ingelheim Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada
      • 1245.28.20072 Boehringer Ingelheim Investigational Site
    • Chicoutimi, Quebec, Canada
      • 1245.28.20081 Boehringer Ingelheim Investigational Site
    • Gatineau, Quebec, Canada
      • 1245.28.20085 Boehringer Ingelheim Investigational Site
    • Longueuil, Quebec, Canada
      • 1245.28.20043 Boehringer Ingelheim Investigational Site
    • Montreal, Quebec, Canada
      • 1245.28.20070 Boehringer Ingelheim Investigational Site
    • Sherbrooke, Quebec, Canada
      • 1245.28.20073 Boehringer Ingelheim Investigational Site
    • Trois Rivieres, Quebec, Canada
      • 1245.28.20021 Boehringer Ingelheim Investigational Site
• Colombia
  • Barranquilla, Colombia
    • 1245.28.57007 Boehringer Ingelheim Investigational Site
  • Bogota, Colombia
    • 1245.28.57005 Boehringer Ingelheim Investigational Site
  • Bogotá, Colombia
    • 1245.28.57003 Boehringer Ingelheim Investigational Site
  • Floridablanca, Colombia
    • 1245.28.57006 Boehringer Ingelheim Investigational Site
• Czech Republic
  • Brno, Czech Republic
    • 1245.28.42003 Boehringer Ingelheim Investigational Site
  • Holice, Czech Republic
    • 1245.28.42005 Boehringer Ingelheim Investigational Site
  • Mlada Boleslav, Czech Republic
    • 1245.28.42002 Boehringer Ingelheim Investigational Site
  • Praha 1, Czech Republic
    • 1245.28.42008 Boehringer Ingelheim Investigational Site
  • Slany, Czech Republic
    • 1245.28.42001 Boehringer Ingelheim Investigational Site
  • Slany, Czech Republic
    • 1245.28.42007 Boehringer Ingelheim Investigational Site
  • Uherske Hradiste, Czech Republic
    • 1245.28.42004 Boehringer Ingelheim Investigational Site
  • Zlin, Czech Republic
    • 1245.28.42006 Boehringer Ingelheim Investigational Site
• Finland
  • Helsinki, Finland
    • 1245.28.72001 Boehringer Ingelheim Investigational Site
  • Joensuu, Finland
    • 1245.28.72004 Boehringer Ingelheim Investigational Site
  • Oulu, Finland
    • 1245.28.72003 Boehringer Ingelheim Investigational Site
  • Pori, Finland
    • 1245.28.72002 Boehringer Ingelheim Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • 1245.28.85201 Boehringer Ingelheim Investigational Site
  • Hong Kong, Hong Kong
    • 1245.28.85207 Boehringer Ingelheim Investigational Site
  • Kowloon, Hong Kong
    • 1245.28.85202 Boehringer Ingelheim Investigational Site
• India
  • Ahmedabad, India
    • 1245.28.91206 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.28.91202 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.28.91204 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.28.91205 Boehringer Ingelheim Investigational Site
  • Bangalore, India
    • 1245.28.91208 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1245.28.91201 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1245.28.91213 Boehringer Ingelheim Investigational Site
  • Hyderabad, India
    • 1245.28.91203 Boehringer Ingelheim Investigational Site
  • Kolkata, India
    • 1245.28.91211 Boehringer Ingelheim Investigational Site
  • Mangalore, India
    • 1245.28.91210 Boehringer Ingelheim Investigational Site
  • New Delhi, India
    • 1245.28.91212 Boehringer Ingelheim Investigational Site
  • Pune, India
    • 1245.28.91207 Boehringer Ingelheim Investigational Site
  • Uttar Pradesh, India
    • 1245.28.91209 Boehringer Ingelheim Investigational Site
• Italy
  • Cagliari, Italy
    • 1245.28.39021 Boehringer Ingelheim Investigational Site
  • Chieri (to), Italy
    • 1245.28.39022 Boehringer Ingelheim Investigational Site
  • Lucca, Italy
    • 1245.28.39016 Boehringer Ingelheim Investigational Site
  • Milano, Italy
    • 1245.28.39018 Boehringer Ingelheim Investigational Site
  • Milano, Italy
    • 1245.28.39019 Boehringer Ingelheim Investigational Site
  • Monserrato (ca), Italy
    • 1245.28.39017 Boehringer Ingelheim Investigational Site
  • Rimini, Italy
    • 1245.28.39023 Boehringer Ingelheim Investigational Site
  • Salerno, Italy
    • 1245.28.39020 Boehringer Ingelheim Investigational Site
• Malaysia
  • Johor Bahru, Malaysia
    • 1245.28.60003 Boehringer Ingelheim Investigational Site
  • Kelantan, Malaysia
    • 1245.28.60006 Boehringer Ingelheim Investigational Site
  • Kuala Lumpur, Malaysia
    • 1245.28.60005 Boehringer Ingelheim Investigational Site
  • Kuala Lumpur, Malaysia
    • 1245.28.60009 Boehringer Ingelheim Investigational Site
  • Pahang, Malaysia
    • 1245.28.60004 Boehringer Ingelheim Investigational Site
  • Perak, Malaysia
    • 1245.28.60007 Boehringer Ingelheim Investigational Site
  • Pulau Pinang, Malaysia
    • 1245.28.60010 Boehringer Ingelheim Investigational Site
  • Selangor Darul Ehsan, Malaysia
    • 1245.28.60001 Boehringer Ingelheim Investigational Site
• Mexico
  • Aguascalientes, Mexico
    • 1245.28.52006 Boehringer Ingelheim Investigational Site
  • Cuautla, Mexico
    • 1245.28.52008 Boehringer Ingelheim Investigational Site
  • Guadalajara, Mexico
    • 1245.28.52009 Boehringer Ingelheim Investigational Site
  • Mexico, Mexico
    • 1245.28.52007 Boehringer Ingelheim Investigational Site
• Netherlands
  • 's HERTOGENBOSCH, Netherlands
    • 1245.28.31008 Boehringer Ingelheim Investigational Site
  • Losser, Netherlands
    • 1245.28.31020 Boehringer Ingelheim Investigational Site
  • Rotterdam, Netherlands
    • 1245.28.31014 Boehringer Ingelheim Investigational Site
• Norway
  • Hønefoss, Norway
    • 1245.28.47002 Boehringer Ingelheim Investigational Site
  • Oslo, Norway
    • 1245.28.47001 Boehringer Ingelheim Investigational Site
  • Sandefjord, Norway
    • 1245.28.47003 Boehringer Ingelheim Investigational Site
• Philippines
  • Cavite City, Philippines
    • 1245.28.63016 Boehringer Ingelheim Investigational Site
  • Cebu City, Philippines
    • 1245.28.63013 Boehringer Ingelheim Investigational Site
  • Jaro Iloilo City, Philippines
    • 1245.28.63020 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.28.63004 Boehringer Ingelheim Investigational Site
  • Manila, Philippines
    • 1245.28.63015 Boehringer Ingelheim Investigational Site
  • Pasig City, Philippines
    • 1245.28.63012 Boehringer Ingelheim Investigational Site
  • Quezon City, Philippines
    • 1245.28.63011 Boehringer Ingelheim Investigational Site
  • Tacloban, Philippines
    • 1245.28.63010 Boehringer Ingelheim Investigational Site
  • Tagbilaran City, Bohol, Philippines
    • 1245.28.63014 Boehringer Ingelheim Investigational Site
• Portugal
  • Amadora, Portugal
    • 1245.28.35006 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1245.28.35002 Boehringer Ingelheim Investigational Site
  • Porto, Portugal
    • 1245.28.35012 Boehringer Ingelheim Investigational Site
  • Vila Nova de Gaia, Portugal
    • 1245.28.35016 Boehringer Ingelheim Investigational Site
• South Africa
  • Boksburg North, South Africa
    • 1245.28.76019 Boehringer Ingelheim Investigational Site
  • Bryanston, South Africa
    • 1245.28.76018 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 1245.28.76016 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 1245.28.76017 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 1245.28.76012 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 1245.28.76015 Boehringer Ingelheim Investigational Site
  • Krugersdorp, South Africa
    • 1245.28.76013 Boehringer Ingelheim Investigational Site
  • Lenasia, South Africa
    • 1245.28.76024 Boehringer Ingelheim Investigational Site
  • Lenasia South, South Africa
    • 1245.28.76023 Boehringer Ingelheim Investigational Site
  • Pretoria, South Africa
    • 1245.28.76014 Boehringer Ingelheim Investigational Site
• Spain
  • Barcelona, Spain
    • 1245.28.34004 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1245.28.34011 Boehringer Ingelheim Investigational Site
  • Burjasot, Spain
    • 1245.28.34002 Boehringer Ingelheim Investigational Site
  • Centelles, Spain
    • 1245.28.34003 Boehringer Ingelheim Investigational Site
  • Granada, Spain
    • 1245.28.34009 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.28.34012 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1245.28.34013 Boehringer Ingelheim Investigational Site
  • Mataró, Spain
    • 1245.28.34005 Boehringer Ingelheim Investigational Site
  • Pineda de Mar, Spain
    • 1245.28.34001 Boehringer Ingelheim Investigational Site
  • San Sebastian de los Reyes, Spain
    • 1245.28.34010 Boehringer Ingelheim Investigational Site
  • Tarrega - Lleida, Spain
    • 1245.28.34006 Boehringer Ingelheim Investigational Site
• Sweden
  • Borås, Sweden
    • 1245.28.46009 Boehringer Ingelheim Investigational Site
  • Lund, Sweden
    • 1245.28.46008 Boehringer Ingelheim Investigational Site
  • Malmö, Sweden
    • 1245.28.46001 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1245.28.46002 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1245.28.46006 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1245.28.46007 Boehringer Ingelheim Investigational Site
  • Uppsala, Sweden
    • 1245.28.46004 Boehringer Ingelheim Investigational Site
  • Örebro, Sweden
    • 1245.28.46005 Boehringer Ingelheim Investigational Site
• Switzerland
  • Ascona, Switzerland
    • 1245.28.41015 Boehringer Ingelheim Investigational Site
  • Bern, Switzerland
    • 1245.28.41017 Inselspital Bern
• Taiwan
  • Changhua, Taiwan
    • 1245.28.88004 Boehringer Ingelheim Investigational Site
  • Taichung, Taiwan
    • 1245.28.88003 Boehringer Ingelheim Investigational Site
  • Tainan Hsien, Taiwan
    • 1245.28.88005 Boehringer Ingelheim Investigational Site
  • Taipei, Taiwan
    • 1245.28.88001 Boehringer Ingelheim Investigational Site
  • Taipei Hsien, Taiwan
    • 1245.28.88002 Boehringer Ingelheim Investigational Site
• Thailand
  • Bangkok, Thailand
    • 1245.28.66006 Boehringer Ingelheim Investigational Site
  • Bangkok, Thailand
    • 1245.28.66007 Boehringer Ingelheim Investigational Site
  • Muang District, Thailand
    • 1245.28.66004 Boehringer Ingelheim Investigational Site
  • Nakhonratchasima, Thailand
    • 1245.28.66008 Boehringer Ingelheim Investigational Site
• United Kingdom
  • Addlestone, United Kingdom
    • 1245.28.44006 Boehringer Ingelheim Investigational Site
  • Ashford, United Kingdom
    • 1245.28.44020 Boehringer Ingelheim Investigational Site
  • Balham, United Kingdom
    • 1245.28.44008 Boehringer Ingelheim Investigational Site
  • Barnstable, United Kingdom
    • 1245.28.44035 Boehringer Ingelheim Investigational Site
  • Blackpool, United Kingdom
    • 1245.28.44016 Boehringer Ingelheim Investigational Site
  • Bradford on Avon, United Kingdom
    • 1245.28.44021 Boehringer Ingelheim Investigational Site
  • Burbage, United Kingdom
    • 1245.28.44019 Boehringer Ingelheim Investigational Site
  • Chestfield, Whitstable, United Kingdom
    • 1245.28.44027 Boehringer Ingelheim Investigational Site
  • Chippenham, United Kingdom
    • 1245.28.44011 Boehringer Ingelheim Investigational Site
  • Chippenham, United Kingdom
    • 1245.28.44022 Boehringer Ingelheim Investigational Site
  • Coventry, United Kingdom
    • 1245.28.44043 Boehringer Ingelheim Investigational Site
  • Doncaster, United Kingdom
    • 1245.28.44025 Boehringer Ingelheim Investigational Site
  • Ely, United Kingdom
    • 1245.28.44030 Boehringer Ingelheim Investigational Site
  • Midsomer Norton, United Kingdom
    • 1245.28.44007 Boehringer Ingelheim Investigational Site
  • Nantwich, United Kingdom
    • 1245.28.44023 Boehringer Ingelheim Investigational Site
  • Whitstable, United Kingdom
    • 1245.28.44017 Boehringer Ingelheim Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States
      • 1245.28.10005 Boehringer Ingelheim Investigational Site
    • Phoenix, Arizona, United States
      • 1245.28.10012 Boehringer Ingelheim Investigational Site
  • Arkansas
    • Hot Springs, Arkansas, United States
      • 1245.28.10016 Boehringer Ingelheim Investigational Site
  • California
    • Sacramento, California, United States
      • 1245.28.10003 Boehringer Ingelheim Investigational Site
    • West Hills, California, United States
      • 1245.28.10021 Boehringer Ingelheim Investigational Site
  • Florida
    • Bradednton, Florida, United States
      • 1245.28.10009 Boehringer Ingelheim Investigational Site
    • Tampa, Florida, United States
      • 1245.28.10015 Boehringer Ingelheim Investigational Site
  • Georgia
    • Blue Ridge, Georgia, United States
      • 1245.28.10033 Boehringer Ingelheim Investigational Site
  • Idaho
    • Boise, Idaho, United States
      • 1245.28.10026 Boehringer Ingelheim Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States
      • 1245.28.10007 Boehringer Ingelheim Investigational Site
  • Nevada
    • Henderson, Nevada, United States
      • 1245.28.10027 Boehringer Ingelheim Investigational Site
  • New York
    • Rochester, New York, United States
      • 1245.28.10014 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Shelby, North Carolina, United States
      • 1245.28.10006 Boehringer Ingelheim Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States
      • 1245.28.10011 Boehringer Ingelheim Investigational Site
    • Cincinnati, Ohio, United States
      • 1245.28.10019 Boehringer Ingelheim Investigational Site
    • Columbus, Ohio, United States
      • 1245.28.10004 Boehringer Ingelheim Investigational Site
    • Perrysburg, Ohio, United States
      • 1245.28.10008 Boehringer Ingelheim Investigational Site
  • Oregon
    • Medford, Oregon, United States
      • 1245.28.10020 Boehringer Ingelheim Investigational Site
    • Portland, Oregon, United States
      • 1245.28.10017 Boehringer Ingelheim Investigational Site
  • Texas
    • Dallas, Texas, United States
      • 1245.28.10031 Boehringer Ingelheim Investigational Site
    • Longview, Texas, United States
      • 1245.28.10032 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 1245.28.10022 Boehringer Ingelheim Investigational Site
  • Utah
    • Draper, Utah, United States
      • 1245.28.10030 Boehringer Ingelheim Investigational Site
    • Salt Lake City, Utah, United States
      • 1245.28.10023 Boehringer Ingelheim Investigational Site
  • Wisconsin
    • Kenosha, Wisconsin, United States
      • 1245.28.10013 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Diagnosis typ 2 diabetes mellitus
• Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
• HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
• 18 years or more
• BMI equal or less than 45Kg/m2

Exclusion criteria:

• Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
• Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
• Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
• Indication of liver disease
• Moderate to severe renal impairment
• Bariatric surgery within past 2 years
• Medical history of cancer or treatment for cancer within last 5 years
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
• Contraindications hypersensitivity to concomitant drugs
• Treatment with anti-obesity drugs

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 10773 dose plus metformin; Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily	Drug: Placebo; Placebo matching Glimepiride; Drug: BI 10773; Medium dose once daily; Drug: Placebo; Placebo matching BI 10773
Active Comparator: Glimepiride 1-4 mg plus metformin; Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.	Drug: Placebo; Placebo matching Glimepiride; Drug: Placebo; Placebo matching BI 10773; Drug: Glimepiride; 1-4 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.	Baseline and 104 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The Change in Body Weight From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.	baseline and 104 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.	baseline and 104 weeks
The Change From Baseline in HbA1c After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Body Weight From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.	baseline and 52 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Eli Lilly and Company

Publications and helpful links

General Publications

• Salem A, Men P, Ramos M, Zhang YJ, Ustyugova A, Lamotte M. Cost-effectiveness analysis of empagliflozin compared with glimepiride in patients with Type 2 diabetes in China. J Comp Eff Res. 2021 Apr;10(6):469-480. doi: 10.2217/cer-2020-0284. Epub 2021 Feb 12.
• Ridderstrale M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):691-700. doi: 10.1016/S2213-8587(14)70120-2. Epub 2014 Jun 16. Erratum In: Lancet Diabetes Endocrinol. 2015 Sept;3(9):e7.
• Ridderstrale M, Svaerd R, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control. Cardiovasc Diabetol. 2013 Sep 5;12:129. doi: 10.1186/1475-2840-12-129.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin; Glimepiride
• Other Study ID Numbers: 1245.28; 2009-016244-39 (EudraCT Number: EudraCT)