Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

January 22, 2016 updated by: Boehringer Ingelheim

A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1413

Phase

  • Phase 3

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

  • Brazil
      • Belém, Brazil
        • 1276.1.55008 Boehringer Ingelheim Investigational Site
      • Brasilia, Brazil
        • 1276.1.55003 Boehringer Ingelheim Investigational Site
      • Fortaleza, Brazil
        • 1276.1.55006 Boehringer Ingelheim Investigational Site
      • Fortaleza, Brazil
        • 1276.1.55007 Boehringer Ingelheim Investigational Site
      • Fortaleza, Brazil
        • 1276.1.55009 Boehringer Ingelheim Investigational Site
      • Goiania, Brazil
        • 1276.1.55004 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 1276.1.55002 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1276.1.55001 Boehringer Ingelheim Investigational Site
  • Canada
      • Quebec, Canada
        • 1276.1.20002 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • 1276.1.20003 Boehringer Ingelheim Investigational Site
      • Coquitlam, British Columbia, Canada
        • 1276.1.20012 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 1276.1.20008 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Antigonish, Nova Scotia, Canada
        • 1276.1.20004 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada
        • 1276.1.20005 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1276.1.20013 Boehringer Ingelheim Investigational Site
      • Strathroy, Ontario, Canada
        • 1276.1.20010 Boehringer Ingelheim Investigational Site
      • Thornhill, Ontario, Canada
        • 1276.1.20006 Boehringer Ingelheim Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada
        • 1276.1.20007 Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 1276.1.20001 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Benatky nad Jizerou, Czech Republic
        • 1276.1.42002 Boehringer Ingelheim Investigational Site
      • Olomouc, Czech Republic
        • 1276.1.42008 Boehringer Ingelheim Investigational Site
      • Ostrava, Czech Republic
        • 1276.1.42007 Boehringer Ingelheim Investigational Site
      • Plzen, Czech Republic
        • 1276.1.42009 Boehringer Ingelheim Investigational Site
      • Praha 1, Czech Republic
        • 1276.1.42010 Boehringer Ingelheim Investigational Site
      • Praha 10, Czech Republic
        • 1276.1.42004 Boehringer Ingelheim Investigational Site
      • Praha 3, Czech Republic
        • 1276.1.42003 Boehringer Ingelheim Investigational Site
  • Egypt
      • Abbasia Cairo, Egypt, Egypt
        • 1276.1.95001 Boehringer Ingelheim Investigational Site
      • Al Manial, Cairo, Egypt, Egypt
        • 1276.1.95003 Boehringer Ingelheim Investigational Site
      • Alexandria, Egypt
        • 1276.1.95004 Boehringer Ingelheim Investigational Site
      • El Darasa Cairo Egypt, Egypt
        • 1276.1.95002 Boehringer Ingelheim Investigational Site
  • France
      • Behren Les Forbach, France
        • 1276.1.33004 Boehringer Ingelheim Investigational Site
      • Bersée, France
        • 1276.1.33012 Boehringer Ingelheim Investigational Site
      • Cournonterral, France
        • 1276.1.33005 Boehringer Ingelheim Investigational Site
      • Hautmont, France
        • 1276.1.33007 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1276.1.33013 Boehringer Ingelheim Investigational Site
      • Poitiers, France
        • 1276.1.33001 Boehringer Ingelheim Investigational Site
      • Savonnières, France
        • 1276.1.33003 Boehringer Ingelheim Investigational Site
      • St Genis des Fontaines, France
        • 1276.1.33006 Boehringer Ingelheim Investigational Site
      • Thouars, France
        • 1276.1.33002 Boehringer Ingelheim Investigational Site
      • Thun St amand, France
        • 1276.1.33011 Boehringer Ingelheim Investigational Site
      • Tours, France
        • 1276.1.33010 Boehringer Ingelheim Investigational Site
      • Vandome, France
        • 1276.1.33009 Boehringer Ingelheim Investigational Site
      • Vieux Condé, France
        • 1276.1.33008 Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1276.1.49005 Boehringer Ingelheim Investigational Site
      • Celle, Germany
        • 1276.1.49008 Boehringer Ingelheim Investigational Site
      • Dortmund, Germany
        • 1276.1.49006 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1276.1.49011 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1276.1.49003 Boehringer Ingelheim Investigational Site
      • Ingelheim, Germany
        • 1276.1.49007 Boehringer Ingelheim Investigational Site
      • Neuwied, Germany
        • 1276.1.49014 Boehringer Ingelheim Investigational Site
      • Offenbach, Germany
        • 1276.1.49004 Boehringer Ingelheim Investigational Site
      • Stuhr-Brinkum, Germany
        • 1276.1.49002 Boehringer Ingelheim Investigational Site
      • Teuchern, Germany
        • 1276.1.49012 Boehringer Ingelheim Investigational Site
  • Guatemala
      • Barbena Santa Rosa, Guatemala
        • 1276.1.50002 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1276.1.50003 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1276.1.50005 Boehringer Ingelheim Investigational Site
      • Guatemala, Guatemala
        • 1276.1.50006 Boehringer Ingelheim Investigational Site
      • Quetzaltenango, Guatemala
        • 1276.1.50001 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Deagu, Korea, Republic of
        • 1276.1.82006 Boehringer Ingelheim Investigational Site
      • Goyang, Korea, Republic of
        • 1276.1.82010 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republic of
        • 1276.1.82001 Boehringer Ingelheim Investigational Site
      • Pusan, Korea, Republic of
        • 1276.1.82009 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1276.1.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1276.1.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1276.1.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1276.1.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1276.1.82008 Boehringer Ingelheim Investigational Site
      • Wonju, Korea, Republic of
        • 1276.1.82003 Boehringer Ingelheim Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • 1276.1.96001 Boehringer Ingelheim Investigational Site
      • El Chouf, Lebanon
        • 1276.1.96002 Boehringer Ingelheim Investigational Site
      • Saida, Lebanon
        • 1276.1.96003 Boehringer Ingelheim Investigational Site
      • Saida, Lebanon
        • 1276.1.96004 Boehringer Ingelheim Investigational Site
  • Malaysia
      • Ipoh, Perak, Malaysia
        • 1276.1.60002 Boehringer Ingelheim Investigational Site
      • Johor Bahru, Malaysia
        • 1276.1.60001 Boehringer Ingelheim Investigational Site
      • Kubang Kerian, Malaysia
        • 1276.1.60003 Boehringer Ingelheim Investigational Site
  • Mexico
      • Aguascalientes, Mexico
        • 1276.1.52004 Boehringer Ingelheim Investigational Site
      • Aguascalientes, Mexico
        • 1276.1.52007 Boehringer Ingelheim Investigational Site
      • Ciudad de Mexico, Mexico
        • 1276.1.52002 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1276.1.52003 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1276.1.52001 Boehringer Ingelheim Investigational Site
      • San Lucas tepetlcalco, Mexico
        • 1276.1.52006 Boehringer Ingelheim Investigational Site
      • Zapopan, Mexico
        • 1276.1.52005 Boehringer Ingelheim Investigational Site
  • Peru
      • Lima, Peru
        • 1276.1.51001 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1276.1.51002 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1276.1.51003 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1276.1.51004 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1276.1.51005 Boehringer Ingelheim Investigational Site
  • Philippines
      • Cebu City, Cebu, Philippines
        • 1276.1.63009 Boehringer Ingelheim Investigational Site
      • Cebu City, Philippines, Philippines
        • 1276.1.63002 Boehringer Ingelheim Investigational Site
      • Davao City, Philippines
        • 1276.1.63004 Boehringer Ingelheim Investigational Site
      • Iloilo City, Philippines
        • 1276.1.63003 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1276.1.63006 Boehringer Ingelheim Investigational Site
      • Marikina City, Philippines
        • 1276.1.63001 Boehringer Ingelheim Investigational Site
      • Maybunga, Pasig City, Philippines
        • 1276.1.63005 Boehringer Ingelheim Investigational Site
      • San Juan City, Philippines
        • 1276.1.63007 Boehringer Ingelheim Investigational Site
      • Tarlac, Philippines
        • 1276.1.63008 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation
        • 1276.1.70012 Boehringer Ingelheim Investigational Site
      • Kemerovo, Russian Federation
        • 1276.1.70011 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • 1276.1.70015 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • 1276.1.70016 Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • 1276.1.70018 Boehringer Ingelheim Investigational Site
      • Petrozavodsk, Russian Federation
        • 1276.1.70007 Boehringer Ingelheim Investigational Site
      • Saratov, Russian Federation
        • 1276.1.70009 Boehringer Ingelheim Investigational Site
      • Smolensk, Russian Federation
        • 1276.1.70010 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1276.1.70005 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1276.1.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1276.1.70017 Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • 1276.1.70013 Boehringer Ingelheim Investigational Site
  • Serbia
      • Belgrade, Serbia
        • 1276.1.38104 Boehringer Ingelheim Investigational Site
      • Belgrade, Serbia
        • 1276.1.38105 Boehringer Ingelheim Investigational Site
      • Belgrade, Serbia
        • 1276.1.38106 Boehringer Ingelheim Investigational Site
      • Belgrade, Serbia
        • 1276.1.38107 Boehringer Ingelheim Investigational Site
      • Kragujevac, Serbia
        • 1276.1.38103 Boehringer Ingelheim Investigational Site
      • Nis, Serbia
        • 1276.1.38101 Boehringer Ingelheim Investigational Site
      • Novi Sad, Serbia
        • 1276.1.38108 Boehringer Ingelheim Investigational Site
      • Zajecar, Serbia
        • 1276.1.38102 Boehringer Ingelheim Investigational Site
  • Spain
      • Alicante, Spain
        • 1276.1.34048 Boehringer Ingelheim Investigational Site
      • Alzira, Spain
        • 1276.1.34050 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1276.1.34028 Boehringer Ingelheim Investigational Site
      • Sabadell (Barcelona), Spain
        • 1276.1.34034 Boehringer Ingelheim Investigational Site
      • Salamanca, Spain
        • 1276.1.34027 Boehringer Ingelheim Investigational Site
      • Tarragona, Spain
        • 1276.1.34052 Boehringer Ingelheim Investigational Site
      • Zaragoza, Spain
        • 1276.1.34051 Boehringer Ingelheim Investigational Site
      • pozuelo de Alarcon, Spain
        • 1276.1.34045 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung City,, Taiwan
        • 1276.1.88005 Boehringer Ingelheim Investigational Site
      • New Taipei City, Taiwan
        • 1276.1.88002 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1276.1.88001 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1276.1.88003 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1276.1.88004 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1276.1.88006 Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand, Thailand
        • 1276.1.66001 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand, Thailand
        • 1276.1.66003 Boehringer Ingelheim Investigational Site
      • Nakhon Ratchasima, Thailand
        • 1276.1.66002 Boehringer Ingelheim Investigational Site
  • Turkey
      • Ankara, Turkey
        • 1276.1.90003 Boehringer Ingelheim Investigational Site
      • Antalya, Turkey
        • 1276.1.90004 Boehringer Ingelheim Investigational Site
      • Denizli, Turkey
        • 1276.1.90006 Boehringer Ingelheim Investigational Site
      • Erzurum, Turkey
        • 1276.1.90002 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1276.1.90005 Boehringer Ingelheim Investigational Site
      • Izmir, Turkey
        • 1276.1.90001 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Bolton, United Kingdom
        • 1276.1.44002 Boehringer Ingelheim Investigational Site
      • Bradford on Avon, United Kingdom
        • 1276.1.44001 Boehringer Ingelheim Investigational Site
      • Chippenham, United Kingdom
        • 1276.1.44005 Boehringer Ingelheim Investigational Site
      • Dagenham, United Kingdom
        • 1276.1.44006 Boehringer Ingelheim Investigational Site
      • Doncaster, United Kingdom
        • 1276.1.44004 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 1276.1.44008 Boehringer Ingelheim Investigational Site
      • Leeds, United Kingdom
        • 1276.1.44003 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1276.1.44007 Boehringer Ingelheim Investigational Site
      • Mortimer, United Kingdom
        • 1276.1.44011 Boehringer Ingelheim Investigational Site
      • Sandbach, United Kingdom
        • 1276.1.44009 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1276.1.10014 Boehringer Ingelheim Investigational Site
      • Birmingham, Alabama, United States
        • 1276.1.10019 Boehringer Ingelheim Investigational Site
    • Alaska
      • Hot Springs, Alaska, United States
        • 1276.1.10044 Boehringer Ingelheim Investigational Site
    • Arizona
      • Glendale, Arizona, United States
        • 1276.1.10010 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Searcy, Arkansas, United States
        • 1276.1.10035 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, United States
        • 1276.1.10046 Boehringer Ingelheim Investigational Site
      • Huntington Beach, California, United States
        • 1276.1.10006 Boehringer Ingelheim Investigational Site
      • La Mesa, California, United States
        • 1276.1.10043 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1276.1.10009 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1276.1.10040 Boehringer Ingelheim Investigational Site
      • Oceanside, California, United States
        • 1276.1.10045 Boehringer Ingelheim Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • 1276.1.10042 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 1276.1.10001 Boehringer Ingelheim Investigational Site
      • Northglenn, Colorado, United States
        • 1276.1.10003 Boehringer Ingelheim Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • 1276.1.10026 Boehringer Ingelheim Investigational Site
      • Oldsmar, Florida, United States
        • 1276.1.10024 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, United States
        • 1276.1.10027 Boehringer Ingelheim Investigational Site
    • Georgia
      • Marietta, Georgia, United States
        • 1276.1.10023 Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • 1276.1.10034 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Fall River, Massachusetts, United States
        • 1276.1.10032 Boehringer Ingelheim Investigational Site
    • Michigan
      • Bridgman, Michigan, United States
        • 1276.1.10036 Boehringer Ingelheim Investigational Site
    • Missouri
      • Hazelwood, Missouri, United States
        • 1276.1.10037 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1276.1.10007 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Union, New Jersey, United States
        • 1276.1.10015 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States
        • 1276.1.10033 Boehringer Ingelheim Investigational Site
      • Burlington, North Carolina, United States
        • 1276.1.10022 Boehringer Ingelheim Investigational Site
      • Lenoir, North Carolina, United States
        • 1276.1.10002 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1276.1.10005 Boehringer Ingelheim Investigational Site
      • Gallipolis, Ohio, United States
        • 1276.1.10011 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States
        • 1276.1.10030 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, United States
        • 1276.1.10008 Boehringer Ingelheim Investigational Site
      • Hodges, South Carolina, United States
        • 1276.1.10013 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Humboldt, Tennessee, United States
        • 1276.1.10017 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • 1276.1.10018 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1276.1.10025 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1276.1.10028 Boehringer Ingelheim Investigational Site
      • Kingwood, Texas, United States
        • 1276.1.10016 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1276.1.10021 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1276.1.10041 Boehringer Ingelheim Investigational Site
    • Virginia
      • Manassas, Virginia, United States
        • 1276.1.10004 Boehringer Ingelheim Investigational Site
    • Washington
      • Wenatchee, Washington, United States
        • 1276.1.10012 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
  3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
  4. Body Mass Index (BMI) <= 45 kg/m2 at screening

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
  2. Any antidiabetic drug within 12 weeks prior to randomization
  3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
  4. Contraindications to metformin according to the local label

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Empagliflozin low dose qd
Empagliflozin low dose once daily
Drug: Empagliflozin low dose qd
Empagliflozin low dose once daily
EXPERIMENTAL: Empagliflozin high dose qd
Empagliflozin high dose once daily
Drug: Empagliflozin high dose qd
Empagliflozin high dose once daily
EXPERIMENTAL: OL empa high dose + met 1000 mg bid
Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
Drug: Metformin 1000 mg bid
Metformin 1000 mg twice daily
Drug: Empagliflozin high dose bid
Empagliflozin high dose split twice daily
EXPERIMENTAL: Empagliflozin low dose + met 500 mg bid
Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Drug: Metformin 500 mg bid
Metformin 500 mg twice daily
Drug: Empagliflozin low dose bid
Empagliflozin low dose split twice daily
EXPERIMENTAL: Empagliflozin low dose + met 1000 mg bid
Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
Drug: Metformin 1000 mg bid
Metformin 1000 mg twice daily
Drug: Empagliflozin low dose bid
Empagliflozin low dose split twice daily
EXPERIMENTAL: Empagliflozin high dose + met 500 mg bid
Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Drug: Empagliflozin high dose bid
Empagliflozin high dose split twice daily
Drug: Metformin 500 mg bid
Metformin 500 mg twice daily
EXPERIMENTAL: Empagliflozin high dose + met 1000mg bid
Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Drug: Metformin 1000 mg bid
Metformin 1000 mg twice daily
Drug: Empagliflozin high dose bid
Empagliflozin high dose split twice daily
EXPERIMENTAL: Metformin 500 mg bid
Metformin 500 mg twice daily
Drug: Metformin 500 mg bid
Metformin 500 mg twice daily
EXPERIMENTAL: Metformin 1000 mg bid
Metformin 1000 mg twice daily
Drug: Metformin 1000 mg bid
Metformin 1000 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Time Frame: baseline and 24 weeks
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
Time Frame: baseline and 24 weeks
Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
baseline and 24 weeks
Body Weight Change From Baseline at Week 24
Time Frame: baseline and 24 weeks
Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.
baseline and 24 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)

November 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (ESTIMATE)

November 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1276.1
  • 2010-021375-92 (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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