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

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01719003
First received: October 30, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Hyperglycemia
Drug: Empagliflozin low dose qd
Drug: Metformin 500 mg bid
Drug: Metformin 1000 mg bid
Drug: Empagliflozin high dose qd
Drug: Empagliflozin low dose bid
Drug: Empagliflozin high dose bid
Phase 3

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 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1397
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Empagliflozin low dose bid
Empagliflozin low dose split twice daily
Drug: Metformin 1000 mg bid
Metformin 1000 mg twice daily
Experimental: Empagliflozin high dose + met 500 mg bid
Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Drug: Metformin 500 mg bid
Metformin 500 mg twice daily
Drug: Empagliflozin high dose bid
Empagliflozin high dose split 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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719003

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Alabama
1276.1.10014 Boehringer Ingelheim Investigational Site Recruiting
Birmingham, Alabama, United States
1276.1.10019 Boehringer Ingelheim Investigational Site Recruiting
Birmingham, Alabama, United States
United States, Alaska
1276.1.10044 Boehringer Ingelheim Investigational Site Recruiting
Hot Springs, Alaska, United States
United States, Arizona
1276.1.10010 Boehringer Ingelheim Investigational Site Recruiting
Glendale, Arizona, United States
United States, Arkansas
1276.1.10035 Boehringer Ingelheim Investigational Site Recruiting
Searcy, Arkansas, United States
United States, California
1276.1.10046 Boehringer Ingelheim Investigational Site Recruiting
Chula Vista, California, United States
1276.1.10006 Boehringer Ingelheim Investigational Site Recruiting
Huntington Beach, California, United States
1276.1.10043 Boehringer Ingelheim Investigational Site Recruiting
La Mesa, California, United States
1276.1.10040 Boehringer Ingelheim Investigational Site Recruiting
Los Angeles, California, United States
1276.1.10009 Boehringer Ingelheim Investigational Site Recruiting
Los Angeles, California, United States
1276.1.10045 Boehringer Ingelheim Investigational Site Recruiting
Oceanside, California, United States
United States, Colorado
1276.1.10042 Boehringer Ingelheim Investigational Site Recruiting
Colorado Springs, Colorado, United States
1276.1.10001 Boehringer Ingelheim Investigational Site Recruiting
Denver, Colorado, United States
1276.1.10003 Boehringer Ingelheim Investigational Site Recruiting
Northglenn, Colorado, United States
United States, Florida
1276.1.10039 Boehringer Ingelheim Investigational Site Recruiting
Fort Lauderdale, Florida, United States
1276.1.10026 Boehringer Ingelheim Investigational Site Recruiting
Fort Lauderdale, Florida, United States
1276.1.10024 Boehringer Ingelheim Investigational Site Recruiting
Oldsmar, Florida, United States
1276.1.10027 Boehringer Ingelheim Investigational Site Recruiting
Port Orange, Florida, United States
United States, Georgia
1276.1.10023 Boehringer Ingelheim Investigational Site Recruiting
Marietta, Georgia, United States
United States, Indiana
1276.1.10034 Boehringer Ingelheim Investigational Site Recruiting
Evansville, Indiana, United States
United States, Massachusetts
1276.1.10032 Boehringer Ingelheim Investigational Site Recruiting
Fall River, Massachusetts, United States
United States, Michigan
1276.1.10036 Boehringer Ingelheim Investigational Site Recruiting
Bridgman, Michigan, United States
United States, Missouri
1276.1.10037 Boehringer Ingelheim Investigational Site Recruiting
Hazelwood, Missouri, United States
United States, Nevada
1276.1.10007 Boehringer Ingelheim Investigational Site Recruiting
Las Vegas, Nevada, United States
United States, New Jersey
1276.1.10015 Boehringer Ingelheim Investigational Site Recruiting
Union, New Jersey, United States
United States, North Carolina
1276.1.10033 Boehringer Ingelheim Investigational Site Recruiting
Asheboro, North Carolina, United States
1276.1.10022 Boehringer Ingelheim Investigational Site Recruiting
Burlington, North Carolina, United States
1276.1.10002 Boehringer Ingelheim Investigational Site Recruiting
Lenoir, North Carolina, United States
United States, Ohio
1276.1.10005 Boehringer Ingelheim Investigational Site Recruiting
Cincinnati, Ohio, United States
1276.1.10011 Boehringer Ingelheim Investigational Site Recruiting
Gallipolis, Ohio, United States
United States, South Carolina
1276.1.10030 Boehringer Ingelheim Investigational Site Recruiting
Columbia, South Carolina, United States
1276.1.10008 Boehringer Ingelheim Investigational Site Recruiting
Greer, South Carolina, United States
1276.1.10013 Boehringer Ingelheim Investigational Site Recruiting
Hodges, South Carolina, United States
United States, Tennessee
1276.1.10017 Boehringer Ingelheim Investigational Site Recruiting
Humboldt, Tennessee, United States
United States, Texas
1276.1.10018 Boehringer Ingelheim Investigational Site Recruiting
Houston, Texas, United States
1276.1.10025 Boehringer Ingelheim Investigational Site Recruiting
Houston, Texas, United States
1276.1.10028 Boehringer Ingelheim Investigational Site Recruiting
Houston, Texas, United States
1276.1.10016 Boehringer Ingelheim Investigational Site Completed
Kingwood, Texas, United States
1276.1.10021 Boehringer Ingelheim Investigational Site Recruiting
San Antonio, Texas, United States
1276.1.10041 Boehringer Ingelheim Investigational Site Recruiting
San Antonio, Texas, United States
United States, Virginia
1276.1.10004 Boehringer Ingelheim Investigational Site Recruiting
Manassas, Virginia, United States
United States, Washington
1276.1.10012 Boehringer Ingelheim Investigational Site Recruiting
Wenatchee, Washington, United States
Brazil
1276.1.55008 Boehringer Ingelheim Investigational Site Recruiting
Belém, Brazil
1276.1.55003 Boehringer Ingelheim Investigational Site Recruiting
Brasilia, Brazil
1276.1.55007 Boehringer Ingelheim Investigational Site Recruiting
Fortaleza, Brazil
1276.1.55006 Boehringer Ingelheim Investigational Site Recruiting
Fortaleza, Brazil
1276.1.55009 Boehringer Ingelheim Investigational Site Recruiting
Fortaleza, Brazil
1276.1.55004 Boehringer Ingelheim Investigational Site Recruiting
Goiania, Brazil
1276.1.55002 Boehringer Ingelheim Investigational Site Recruiting
Porto Alegre, Brazil
1276.1.55001 Boehringer Ingelheim Investigational Site Recruiting
Sao Paulo, Brazil
Canada, British Columbia
1276.1.20003 Boehringer Ingelheim Investigational Site Recruiting
Coquitlam, British Columbia, Canada
1276.1.20012 Boehringer Ingelheim Investigational Site Recruiting
Coquitlam, British Columbia, Canada
1276.1.20008 Boehringer Ingelheim Investigational Site Recruiting
Victoria, British Columbia, Canada
Canada, Nova Scotia
1276.1.20004 Boehringer Ingelheim Investigational Site Recruiting
Antigonish, Nova Scotia, Canada
Canada, Ontario
1276.1.20005 Boehringer Ingelheim Investigational Site Recruiting
Hawkesbury, Ontario, Canada
1276.1.20013 Boehringer Ingelheim Investigational Site Recruiting
Sarnia, Ontario, Canada
1276.1.20011 Boehringer Ingelheim Investigational Site Recruiting
Stayner, Ontario, Canada
1276.1.20010 Boehringer Ingelheim Investigational Site Recruiting
Strathroy, Ontario, Canada
1276.1.20006 Boehringer Ingelheim Investigational Site Recruiting
Thornhill, Ontario, Canada
1276.1.20009 Boehringer Ingelheim Investigational Site Recruiting
Toronto, Ontario, Canada
Canada, Quebec
1276.1.20007 Boehringer Ingelheim Investigational Site Recruiting
Mirabel, Quebec, Canada
Canada, Saskatchewan
1276.1.20001 Boehringer Ingelheim Investigational Site Recruiting
Saskatoon, Saskatchewan, Canada
Canada
1276.1.20002 Boehringer Ingelheim Investigational Site Recruiting
Quebec, Canada
Czech Republic
1276.1.42002 Boehringer Ingelheim Investigational Site Recruiting
Benatky nad Jizerou, Czech Republic
1276.1.42008 Boehringer Ingelheim Investigational Site Recruiting
Olomouc, Czech Republic
1276.1.42007 Boehringer Ingelheim Investigational Site Recruiting
Ostrava, Czech Republic
1276.1.42009 Boehringer Ingelheim Investigational Site Recruiting
Plzen, Czech Republic
1276.1.42010 Boehringer Ingelheim Investigational Site Recruiting
Praha 1, Czech Republic
1276.1.42004 Boehringer Ingelheim Investigational Site Recruiting
Praha 10, Czech Republic
1276.1.42003 Boehringer Ingelheim Investigational Site Recruiting
Praha 3, Czech Republic
Egypt
1276.1.95001 Boehringer Ingelheim Investigational Site Recruiting
Abbasia Cairo, Egypt, Egypt
1276.1.95003 Boehringer Ingelheim Investigational Site Recruiting
Al Manial, Cairo, Egypt, Egypt
1276.1.95004 Boehringer Ingelheim Investigational Site Recruiting
Alexandria, Egypt
1276.1.95005 Boehringer Ingelheim Investigational Site Recruiting
Alexandria, Egypt
1276.1.95002 Boehringer Ingelheim Investigational Site Recruiting
El Darasa Cairo Egypt, Egypt
France
1276.1.33004 Boehringer Ingelheim Investigational Site Completed
Behren Les Forbach, France
1276.1.33012 Boehringer Ingelheim Investigational Site Recruiting
Bersée, France
1276.1.33005 Boehringer Ingelheim Investigational Site Recruiting
Cournonterral, France
1276.1.33007 Boehringer Ingelheim Investigational Site Completed
Hautmont, France
1276.1.33013 Boehringer Ingelheim Investigational Site Recruiting
Paris, France
1276.1.33001 Boehringer Ingelheim Investigational Site Recruiting
Poitiers, France
1276.1.33003 Boehringer Ingelheim Investigational Site Recruiting
Savonnières, France
1276.1.33006 Boehringer Ingelheim Investigational Site Recruiting
St Genis des Fontaines, France
1276.1.33002 Boehringer Ingelheim Investigational Site Recruiting
Thouars, France
1276.1.33011 Boehringer Ingelheim Investigational Site Recruiting
Thun St amand, France
1276.1.33010 Boehringer Ingelheim Investigational Site Recruiting
Tours, France
1276.1.33009 Boehringer Ingelheim Investigational Site Recruiting
Vandome, France
1276.1.33008 Boehringer Ingelheim Investigational Site Recruiting
Vieux Condé, France
Germany
1276.1.49005 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1276.1.49008 Boehringer Ingelheim Investigational Site Recruiting
Celle, Germany
1276.1.49006 Boehringer Ingelheim Investigational Site Recruiting
Dortmund, Germany
1276.1.49011 Boehringer Ingelheim Investigational Site Recruiting
Dresden, Germany
1276.1.49003 Boehringer Ingelheim Investigational Site Recruiting
Essen, Germany
1276.1.49007 Boehringer Ingelheim Investigational Site Terminated
Ingelheim, Germany
1276.1.49014 Boehringer Ingelheim Investigational Site Recruiting
Neuwied, Germany
1276.1.49004 Boehringer Ingelheim Investigational Site Recruiting
Offenbach, Germany
1276.1.49002 Boehringer Ingelheim Investigational Site Recruiting
Stuhr-Brinkum, Germany
1276.1.49012 Boehringer Ingelheim Investigational Site Recruiting
Teuchern, Germany
Guatemala
1276.1.50002 Boehringer Ingelheim Investigational Site Recruiting
Barbena Santa Rosa, Guatemala
1276.1.50003 Boehringer Ingelheim Investigational Site Recruiting
Guatemala, Guatemala
1276.1.50005 Boehringer Ingelheim Investigational Site Recruiting
Guatemala, Guatemala
1276.1.50006 Boehringer Ingelheim Investigational Site Recruiting
Guatemala, Guatemala
1276.1.50001 Boehringer Ingelheim Investigational Site Recruiting
Quetzaltenango, Guatemala
Korea, Republic of
1276.1.82009 Boehringer Ingelheim Investigational Site Recruiting
Busan, Korea, Republic of
1276.1.82006 Boehringer Ingelheim Investigational Site Recruiting
Deagu, Korea, Republic of
1276.1.82010 Boehringer Ingelheim Investigational Site Recruiting
Goyang, Korea, Republic of
1276.1.82001 Boehringer Ingelheim Investigational Site Recruiting
Incheon, Korea, Republic of
1276.1.82005 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1276.1.82008 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1276.1.82004 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1276.1.82002 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1276.1.82007 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1276.1.82003 Boehringer Ingelheim Investigational Site Recruiting
Wonju, Korea, Republic of
Lebanon
1276.1.96001 Boehringer Ingelheim Investigational Site Recruiting
Beirut, Lebanon
1276.1.96002 Boehringer Ingelheim Investigational Site Recruiting
Chouf, Lebanon
1276.1.96003 Boehringer Ingelheim Investigational Site Recruiting
Sidon, Lebanon
1276.1.96004 Boehringer Ingelheim Investigational Site Recruiting
Sidon, Lebanon
Malaysia
1276.1.60002 Boehringer Ingelheim Investigational Site Recruiting
Ipoh, Perak, Malaysia
1276.1.60001 Boehringer Ingelheim Investigational Site Recruiting
Johor Bahru, Malaysia
1276.1.60003 Boehringer Ingelheim Investigational Site Recruiting
Kubang Kerian, Malaysia
Mexico
1276.1.52004 Boehringer Ingelheim Investigational Site Recruiting
Aguascalientes, Mexico
1276.1.52007 Boehringer Ingelheim Investigational Site Recruiting
Aguascalientes, Mexico
1276.1.52002 Boehringer Ingelheim Investigational Site Recruiting
Ciudad de Mexico, Mexico
1276.1.52003 Boehringer Ingelheim Investigational Site Recruiting
Guadalajara, Mexico
1276.1.52001 Boehringer Ingelheim Investigational Site Recruiting
Monterrey, Mexico
1276.1.52006 Boehringer Ingelheim Investigational Site Recruiting
San Lucas tepetlcalco, Mexico
1276.1.52005 Boehringer Ingelheim Investigational Site Recruiting
Zapopan, Mexico
Peru
1276.1.51001 Boehringer Ingelheim Investigational Site Recruiting
Lima, Peru
1276.1.51002 Boehringer Ingelheim Investigational Site Recruiting
Lima, Peru
1276.1.51003 Boehringer Ingelheim Investigational Site Recruiting
Lima, Peru
1276.1.51004 Boehringer Ingelheim Investigational Site Recruiting
Lima, Peru
1276.1.51005 Boehringer Ingelheim Investigational Site Recruiting
Lima, Peru
Philippines
1276.1.63009 Boehringer Ingelheim Investigational Site Recruiting
Cebu City, Cebu, Philippines
1276.1.63002 Boehringer Ingelheim Investigational Site Recruiting
Cebu City, Philippines, Philippines
1276.1.63004 Boehringer Ingelheim Investigational Site Recruiting
Davao City, Philippines
1276.1.63003 Boehringer Ingelheim Investigational Site Recruiting
Iloilo City, Philippines
1276.1.63006 Boehringer Ingelheim Investigational Site Recruiting
Manila, Philippines
1276.1.63001 Boehringer Ingelheim Investigational Site Recruiting
Marikina City, Philippines
1276.1.63005 Boehringer Ingelheim Investigational Site Recruiting
Maybunga, Pasig City, Philippines
1276.1.63007 Boehringer Ingelheim Investigational Site Recruiting
San Juan City, Philippines
1276.1.63008 Boehringer Ingelheim Investigational Site Recruiting
Tarlac, Philippines
Russian Federation
1276.1.70012 Boehringer Ingelheim Investigational Site Recruiting
Barnaul, Russian Federation
1276.1.70011 Boehringer Ingelheim Investigational Site Recruiting
Kemerovo, Russian Federation
1276.1.70018 Boehringer Ingelheim Investigational Site Recruiting
Novosibirsk, Russian Federation
1276.1.70015 Boehringer Ingelheim Investigational Site Recruiting
Novosibirsk, Russian Federation
1276.1.70016 Boehringer Ingelheim Investigational Site Recruiting
Novosibirsk, Russian Federation
1276.1.70007 Boehringer Ingelheim Investigational Site Recruiting
Petrozavodsk, Russian Federation
1276.1.70009 Boehringer Ingelheim Investigational Site Recruiting
Saratov, Russian Federation
1276.1.70010 Boehringer Ingelheim Investigational Site Recruiting
Smolensk, Russian Federation
1276.1.70006 Boehringer Ingelheim Investigational Site Recruiting
St. Petersburg, Russian Federation
1276.1.70005 Boehringer Ingelheim Investigational Site Recruiting
St. Petersburg, Russian Federation
1276.1.70017 Boehringer Ingelheim Investigational Site Recruiting
St. Petersburg, Russian Federation
1276.1.70013 Boehringer Ingelheim Investigational Site Recruiting
Yaroslavl, Russian Federation
Serbia
1276.1.38105 Boehringer Ingelheim Investigational Site Recruiting
Belgrade, Serbia
1276.1.38107 Boehringer Ingelheim Investigational Site Recruiting
Belgrade, Serbia
1276.1.38106 Boehringer Ingelheim Investigational Site Recruiting
Belgrade, Serbia
1276.1.38104 Boehringer Ingelheim Investigational Site Recruiting
Belgrade, Serbia
1276.1.38103 Boehringer Ingelheim Investigational Site Recruiting
Kragujevac, Serbia
1276.1.38101 Boehringer Ingelheim Investigational Site Recruiting
Nis, Serbia
1276.1.38108 Boehringer Ingelheim Investigational Site Recruiting
Novi Sad, Serbia
1276.1.38102 Boehringer Ingelheim Investigational Site Recruiting
Zajecar, Serbia
Spain
1276.1.34048 Boehringer Ingelheim Investigational Site Recruiting
Alicante, Spain
1276.1.34050 Boehringer Ingelheim Investigational Site Recruiting
Alzira, Spain
1276.1.34028 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1276.1.34045 Boehringer Ingelheim Investigational Site Recruiting
pozuelo de Alarcon, Spain
1276.1.34034 Boehringer Ingelheim Investigational Site Recruiting
Sabadell (Barcelona), Spain
1276.1.34027 Boehringer Ingelheim Investigational Site Recruiting
Salamanca, Spain
1276.1.34052 Boehringer Ingelheim Investigational Site Recruiting
Tarragona, Spain
1276.1.34051 Boehringer Ingelheim Investigational Site Recruiting
Zaragoza, Spain
Taiwan
1276.1.88005 Boehringer Ingelheim Investigational Site Recruiting
Kaohsiung City,, Taiwan
1276.1.88002 Boehringer Ingelheim Investigational Site Recruiting
New Taipei City, Taiwan
1276.1.88004 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1276.1.88001 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1276.1.88003 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1276.1.88006 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
Thailand
1276.1.66001 Boehringer Ingelheim Investigational Site Recruiting
Bangkok, Thailand, Thailand
1276.1.66003 Boehringer Ingelheim Investigational Site Recruiting
Bangkok, Thailand, Thailand
1276.1.66002 Boehringer Ingelheim Investigational Site Recruiting
Nakhon Ratchasima, Thailand
Turkey
1276.1.90003 Boehringer Ingelheim Investigational Site Recruiting
Ankara, Turkey
1276.1.90004 Boehringer Ingelheim Investigational Site Recruiting
Antalya, Turkey
1276.1.90006 Boehringer Ingelheim Investigational Site Recruiting
Denizli, Turkey
1276.1.90002 Boehringer Ingelheim Investigational Site Recruiting
Erzurum, Turkey
1276.1.90005 Boehringer Ingelheim Investigational Site Recruiting
Istanbul, Turkey
1276.1.90001 Boehringer Ingelheim Investigational Site Recruiting
Izmir, Turkey
United Kingdom
1276.1.44002 Boehringer Ingelheim Investigational Site Recruiting
Bolton, United Kingdom
1276.1.44001 Boehringer Ingelheim Investigational Site Recruiting
Bradford on Avon, United Kingdom
1276.1.44005 Boehringer Ingelheim Investigational Site Recruiting
Chippenham, United Kingdom
1276.1.44006 Boehringer Ingelheim Investigational Site Recruiting
Dagenham, United Kingdom
1276.1.44004 Boehringer Ingelheim Investigational Site Recruiting
Doncaster, United Kingdom
1276.1.44008 Boehringer Ingelheim Investigational Site Recruiting
Glasgow, United Kingdom
1276.1.44003 Boehringer Ingelheim Investigational Site Recruiting
Leeds, United Kingdom
1276.1.44007 Boehringer Ingelheim Investigational Site Recruiting
Manchester, United Kingdom
1276.1.44011 Boehringer Ingelheim Investigational Site Recruiting
Mortimer, United Kingdom
1276.1.44009 Boehringer Ingelheim Investigational Site Recruiting
Sandbach, United Kingdom
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: NCT01719003     History of Changes
Other Study ID Numbers: 1276.1, 2010-021375-92
Study First Received: October 30, 2012
Last Updated: April 16, 2014
Health Authority: Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Egypt: Ministry of Health, Drug Policy and Planning Center
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Public Health and Social Assistance
Lebanon: Institutional Review Board
Malaysia: Ministry of Health
Mexico: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014