Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01167881
First received: July 15, 2010
Last updated: July 28, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: BI 10773 Drug: Glimepiride Drug: Placebo |
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 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. [ Time Frame: Baseline and 104 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The Change in Body Weight From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
- The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
- The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
- The Change From Baseline in HbA1c After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The Change in Body Weight From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1549 |
| Study Start Date: | August 2010 |
| Study Completion Date: | August 2015 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BI 10773 dose plus metformin
Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
|
Drug: BI 10773
Medium dose once daily
Drug: Placebo
Placebo matching Glimepiride
|
|
Active Comparator: Glimepiride 1-4 mg plus metformin
Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
|
Drug: Glimepiride
1-4 mg once daily
Drug: Placebo
Placebo matching BI 10773
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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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: NCT01167881
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01167881
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Locations
| United States, Arizona | |
| 1245.28.10005 Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| 1245.28.10012 Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| United States, Arkansas | |
| 1245.28.10016 Boehringer Ingelheim Investigational Site | |
| Hot Springs, Arkansas, United States | |
| United States, California | |
| 1245.28.10003 Boehringer Ingelheim Investigational Site | |
| Sacramento, California, United States | |
| 1245.28.10021 Boehringer Ingelheim Investigational Site | |
| West Hills, California, United States | |
| United States, Florida | |
| 1245.28.10009 Boehringer Ingelheim Investigational Site | |
| Bradednton, Florida, United States | |
| 1245.28.10015 Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| 1245.28.10033 Boehringer Ingelheim Investigational Site | |
| Blue Ridge, Georgia, United States | |
| United States, Idaho | |
| 1245.28.10026 Boehringer Ingelheim Investigational Site | |
| Boise, Idaho, United States | |
| United States, Nebraska | |
| 1245.28.10007 Boehringer Ingelheim Investigational Site | |
| Omaha, Nebraska, United States | |
| United States, Nevada | |
| 1245.28.10027 Boehringer Ingelheim Investigational Site | |
| Henderson, Nevada, United States | |
| United States, New York | |
| 1245.28.10014 Boehringer Ingelheim Investigational Site | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| 1245.28.10006 Boehringer Ingelheim Investigational Site | |
| Shelby, North Carolina, United States | |
| United States, Ohio | |
| 1245.28.10011 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 1245.28.10019 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| 1245.28.10004 Boehringer Ingelheim Investigational Site | |
| Columbus, Ohio, United States | |
| 1245.28.10008 Boehringer Ingelheim Investigational Site | |
| Perrysburg, Ohio, United States | |
| United States, Oregon | |
| 1245.28.10020 Boehringer Ingelheim Investigational Site | |
| Medford, Oregon, United States | |
| 1245.28.10017 Boehringer Ingelheim Investigational Site | |
| Portland, Oregon, United States | |
| United States, Texas | |
| 1245.28.10031 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 1245.28.10032 Boehringer Ingelheim Investigational Site | |
| Longview, Texas, United States | |
| 1245.28.10022 Boehringer Ingelheim Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| 1245.28.10030 Boehringer Ingelheim Investigational Site | |
| Draper, Utah, United States | |
| 1245.28.10023 Boehringer Ingelheim Investigational Site | |
| Salt Lake City, Utah, United States | |
| United States, Wisconsin | |
| 1245.28.10013 Boehringer Ingelheim Investigational Site | |
| Kenosha, Wisconsin, United States | |
| Argentina | |
| 1245.28.54010 Boehringer Ingelheim Investigational Site | |
| Buenos Aires, Argentina | |
| 1245.28.54001 Boehringer Ingelheim Investigational Site | |
| Capital Federal, Argentina | |
| 1245.28.54002 Boehringer Ingelheim Investigational Site | |
| Córdoba, Argentina | |
| 1245.28.54003 Boehringer Ingelheim Investigational Site | |
| Córdoba, Argentina | |
| Austria | |
| 1245.28.43006 Boehringer Ingelheim Investigational Site | |
| Graz, Austria | |
| 1245.28.43005 Boehringer Ingelheim Investigational Site | |
| Salzburg, 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 | |
| Wien, Austria | |
| Canada, Alberta | |
| 1245.28.20074 Boehringer Ingelheim Investigational Site | |
| Calgary, Alberta, Canada | |
| 1245.28.20077 Boehringer Ingelheim Investigational Site | |
| Calgary, Alberta, Canada | |
| 1245.28.20075 Boehringer Ingelheim Investigational Site | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| 1245.28.20084 Boehringer Ingelheim Investigational Site | |
| Langley, British Columbia, Canada | |
| Canada, Newfoundland and Labrador | |
| 1245.28.20082 Boehringer Ingelheim Investigational Site | |
| Grand Falls-Windsor, Newfoundland and Labrador, Canada | |
| 1245.28.20016 Boehringer Ingelheim Investigational Site | |
| Mount Pearl, Newfoundland and Labrador, Canada | |
| 1245.28.20079 Boehringer Ingelheim Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Nova Scotia | |
| 1245.28.20071 Boehringer Ingelheim Investigational Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| 1245.28.20080 Boehringer Ingelheim Investigational Site | |
| Collingwood, Ontario, Canada | |
| 1245.28.20078 Boehringer Ingelheim Investigational Site | |
| Stayner, Ontario, Canada | |
| 1245.28.20005 Boehringer Ingelheim Investigational Site | |
| Strathroy, Ontario, Canada | |
| 1245.28.20083 Boehringer Ingelheim Investigational Site | |
| Sudbury, Ontario, Canada | |
| Canada, Quebec | |
| 1245.28.20072 Boehringer Ingelheim Investigational Site | |
| Chicoutimi, Quebec, Canada | |
| 1245.28.20081 Boehringer Ingelheim Investigational Site | |
| Chicoutimi, Quebec, Canada | |
| 1245.28.20085 Boehringer Ingelheim Investigational Site | |
| Gatineau, Quebec, Canada | |
| 1245.28.20043 Boehringer Ingelheim Investigational Site | |
| Longueuil, Quebec, Canada | |
| 1245.28.20070 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| 1245.28.20073 Boehringer Ingelheim Investigational Site | |
| Sherbrooke, Quebec, Canada | |
| 1245.28.20021 Boehringer Ingelheim Investigational Site | |
| Trois Rivieres, Quebec, Canada | |
| Canada | |
| 1245.28.20076 Boehringer Ingelheim Investigational Site | |
| Quebec, Canada | |
| Colombia | |
| 1245.28.57007 Boehringer Ingelheim Investigational Site | |
| Barranquilla, Colombia | |
| 1245.28.57005 Boehringer Ingelheim Investigational Site | |
| Bogota, Colombia | |
| 1245.28.57003 Boehringer Ingelheim Investigational Site | |
| Bogotá, Colombia | |
| 1245.28.57006 Boehringer Ingelheim Investigational Site | |
| Floridablanca, Colombia | |
| Czech Republic | |
| 1245.28.42003 Boehringer Ingelheim Investigational Site | |
| Brno, Czech Republic | |
| 1245.28.42005 Boehringer Ingelheim Investigational Site | |
| Holice, Czech Republic | |
| 1245.28.42002 Boehringer Ingelheim Investigational Site | |
| Mlada Boleslav, Czech Republic | |
| 1245.28.42008 Boehringer Ingelheim Investigational Site | |
| Praha 1, Czech Republic | |
| 1245.28.42001 Boehringer Ingelheim Investigational Site | |
| Slany, Czech Republic | |
| 1245.28.42007 Boehringer Ingelheim Investigational Site | |
| Slany, Czech Republic | |
| 1245.28.42004 Boehringer Ingelheim Investigational Site | |
| Uherske Hradiste, Czech Republic | |
| 1245.28.42006 Boehringer Ingelheim Investigational Site | |
| Zlin, Czech Republic | |
| Finland | |
| 1245.28.72001 Boehringer Ingelheim Investigational Site | |
| Helsinki, Finland | |
| 1245.28.72004 Boehringer Ingelheim Investigational Site | |
| Joensuu, Finland | |
| 1245.28.72003 Boehringer Ingelheim Investigational Site | |
| Oulu, Finland | |
| 1245.28.72002 Boehringer Ingelheim Investigational Site | |
| Pori, Finland | |
| Hong Kong | |
| 1245.28.85201 Boehringer Ingelheim Investigational Site | |
| Hong Kong, Hong Kong | |
| 1245.28.85207 Boehringer Ingelheim Investigational Site | |
| Hong Kong, Hong Kong | |
| 1245.28.85202 Boehringer Ingelheim Investigational Site | |
| Kowloon, Hong Kong | |
| India | |
| 1245.28.91206 Boehringer Ingelheim Investigational Site | |
| Ahmedabad, 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 | |
| Bangalore, India | |
| 1245.28.91201 Boehringer Ingelheim Investigational Site | |
| Chennai, India | |
| 1245.28.91213 Boehringer Ingelheim Investigational Site | |
| Chennai, India | |
| 1245.28.91203 Boehringer Ingelheim Investigational Site | |
| Hyderabad, India | |
| 1245.28.91211 Boehringer Ingelheim Investigational Site | |
| Kolkata, India | |
| 1245.28.91210 Boehringer Ingelheim Investigational Site | |
| Mangalore, India | |
| 1245.28.91212 Boehringer Ingelheim Investigational Site | |
| New Delhi, India | |
| 1245.28.91207 Boehringer Ingelheim Investigational Site | |
| Pune, India | |
| 1245.28.91209 Boehringer Ingelheim Investigational Site | |
| Uttar Pradesh, India | |
| Italy | |
| 1245.28.39021 Boehringer Ingelheim Investigational Site | |
| Cagliari, Italy | |
| 1245.28.39022 Boehringer Ingelheim Investigational Site | |
| Chieri (to), Italy | |
| 1245.28.39016 Boehringer Ingelheim Investigational Site | |
| Lucca, Italy | |
| 1245.28.39018 Boehringer Ingelheim Investigational Site | |
| Milano, Italy | |
| 1245.28.39019 Boehringer Ingelheim Investigational Site | |
| Milano, Italy | |
| 1245.28.39017 Boehringer Ingelheim Investigational Site | |
| Monserrato (ca), Italy | |
| 1245.28.39023 Boehringer Ingelheim Investigational Site | |
| Rimini, Italy | |
| 1245.28.39020 Boehringer Ingelheim Investigational Site | |
| Salerno, Italy | |
| Malaysia | |
| 1245.28.60003 Boehringer Ingelheim Investigational Site | |
| Johor Bahru, Malaysia | |
| 1245.28.60006 Boehringer Ingelheim Investigational Site | |
| Kelantan, Malaysia | |
| 1245.28.60005 Boehringer Ingelheim Investigational Site | |
| Kuala Lumpur, Malaysia | |
| 1245.28.60009 Boehringer Ingelheim Investigational Site | |
| Kuala Lumpur, Malaysia | |
| 1245.28.60004 Boehringer Ingelheim Investigational Site | |
| Pahang, Malaysia | |
| 1245.28.60007 Boehringer Ingelheim Investigational Site | |
| Perak, Malaysia | |
| 1245.28.60010 Boehringer Ingelheim Investigational Site | |
| Pulau Pinang, Malaysia | |
| 1245.28.60001 Boehringer Ingelheim Investigational Site | |
| Selangor Darul Ehsan, Malaysia | |
| Mexico | |
| 1245.28.52006 Boehringer Ingelheim Investigational Site | |
| Aguascalientes, Mexico | |
| 1245.28.52008 Boehringer Ingelheim Investigational Site | |
| Cuautla, Mexico | |
| 1245.28.52009 Boehringer Ingelheim Investigational Site | |
| Guadalajara, Mexico | |
| 1245.28.52007 Boehringer Ingelheim Investigational Site | |
| Mexico, Mexico | |
| Netherlands | |
| 1245.28.31008 Boehringer Ingelheim Investigational Site | |
| 's HERTOGENBOSCH, Netherlands | |
| 1245.28.31020 Boehringer Ingelheim Investigational Site | |
| Losser, Netherlands | |
| 1245.28.31014 Boehringer Ingelheim Investigational Site | |
| Rotterdam, Netherlands | |
| Norway | |
| 1245.28.47002 Boehringer Ingelheim Investigational Site | |
| Hønefoss, Norway | |
| 1245.28.47001 Boehringer Ingelheim Investigational Site | |
| Oslo, Norway | |
| 1245.28.47003 Boehringer Ingelheim Investigational Site | |
| Sandefjord, Norway | |
| Philippines | |
| 1245.28.63016 Boehringer Ingelheim Investigational Site | |
| Cavite City, Philippines | |
| 1245.28.63013 Boehringer Ingelheim Investigational Site | |
| Cebu City, Philippines | |
| 1245.28.63020 Boehringer Ingelheim Investigational Site | |
| Jaro Iloilo City, Philippines | |
| 1245.28.63004 Boehringer Ingelheim Investigational Site | |
| Manila, Philippines | |
| 1245.28.63015 Boehringer Ingelheim Investigational Site | |
| Manila, Philippines | |
| 1245.28.63012 Boehringer Ingelheim Investigational Site | |
| Pasig City, Philippines | |
| 1245.28.63011 Boehringer Ingelheim Investigational Site | |
| Quezon City, Philippines | |
| 1245.28.63010 Boehringer Ingelheim Investigational Site | |
| Tacloban, Philippines | |
| 1245.28.63014 Boehringer Ingelheim Investigational Site | |
| Tagbilaran City, Bohol, Philippines | |
| Portugal | |
| 1245.28.35006 Boehringer Ingelheim Investigational Site | |
| Amadora, Portugal | |
| 1245.28.35002 Boehringer Ingelheim Investigational Site | |
| Lisboa, Portugal | |
| 1245.28.35012 Boehringer Ingelheim Investigational Site | |
| Porto, Portugal | |
| 1245.28.35016 Boehringer Ingelheim Investigational Site | |
| Vila Nova de Gaia, Portugal | |
| South Africa | |
| 1245.28.76019 Boehringer Ingelheim Investigational Site | |
| Boksburg North, South Africa | |
| 1245.28.76018 Boehringer Ingelheim Investigational Site | |
| Bryanston, South Africa | |
| 1245.28.76016 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1245.28.76017 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1245.28.76012 Boehringer Ingelheim Investigational Site | |
| Durban, South Africa | |
| 1245.28.76015 Boehringer Ingelheim Investigational Site | |
| Durban, South Africa | |
| 1245.28.76013 Boehringer Ingelheim Investigational Site | |
| Krugersdorp, South Africa | |
| 1245.28.76023 Boehringer Ingelheim Investigational Site | |
| Lenasia South, South Africa | |
| 1245.28.76024 Boehringer Ingelheim Investigational Site | |
| Lenasia, South Africa | |
| 1245.28.76014 Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa | |
| Spain | |
| 1245.28.34004 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1245.28.34011 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1245.28.34002 Boehringer Ingelheim Investigational Site | |
| Burjasot, Spain | |
| 1245.28.34003 Boehringer Ingelheim Investigational Site | |
| Centelles, Spain | |
| 1245.28.34009 Boehringer Ingelheim Investigational Site | |
| Granada, Spain | |
| 1245.28.34012 Boehringer Ingelheim Investigational Site | |
| Madrid, Spain | |
| 1245.28.34013 Boehringer Ingelheim Investigational Site | |
| Madrid, Spain | |
| 1245.28.34005 Boehringer Ingelheim Investigational Site | |
| Mataró, Spain | |
| 1245.28.34001 Boehringer Ingelheim Investigational Site | |
| Pineda de Mar, Spain | |
| 1245.28.34010 Boehringer Ingelheim Investigational Site | |
| San Sebastian de los Reyes, Spain | |
| 1245.28.34006 Boehringer Ingelheim Investigational Site | |
| Tarrega - Lleida, Spain | |
| Sweden | |
| 1245.28.46009 Boehringer Ingelheim Investigational Site | |
| Borås, Sweden | |
| 1245.28.46008 Boehringer Ingelheim Investigational Site | |
| Lund, Sweden | |
| 1245.28.46001 Boehringer Ingelheim Investigational Site | |
| Malmö, 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 | |
| Stockholm, Sweden | |
| 1245.28.46004 Boehringer Ingelheim Investigational Site | |
| Uppsala, Sweden | |
| 1245.28.46005 Boehringer Ingelheim Investigational Site | |
| Örebro, Sweden | |
| Switzerland | |
| 1245.28.41015 Boehringer Ingelheim Investigational Site | |
| Ascona, Switzerland | |
| 1245.28.41017 Inselspital Bern | |
| Bern, Switzerland | |
| Taiwan | |
| 1245.28.88004 Boehringer Ingelheim Investigational Site | |
| Changhua, Taiwan | |
| 1245.28.88003 Boehringer Ingelheim Investigational Site | |
| Taichung, Taiwan | |
| 1245.28.88005 Boehringer Ingelheim Investigational Site | |
| Tainan Hsien, Taiwan | |
| 1245.28.88002 Boehringer Ingelheim Investigational Site | |
| Taipei Hsien, Taiwan | |
| 1245.28.88001 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| Thailand | |
| 1245.28.66006 Boehringer Ingelheim Investigational Site | |
| Bangkok, Thailand | |
| 1245.28.66007 Boehringer Ingelheim Investigational Site | |
| Bangkok, Thailand | |
| 1245.28.66004 Boehringer Ingelheim Investigational Site | |
| Muang District, Thailand | |
| 1245.28.66008 Boehringer Ingelheim Investigational Site | |
| Nakhonratchasima, Thailand | |
| United Kingdom | |
| 1245.28.44006 Boehringer Ingelheim Investigational Site | |
| Addlestone, United Kingdom | |
| 1245.28.44020 Boehringer Ingelheim Investigational Site | |
| Ashford, United Kingdom | |
| 1245.28.44008 Boehringer Ingelheim Investigational Site | |
| Balham, United Kingdom | |
| 1245.28.44035 Boehringer Ingelheim Investigational Site | |
| Barnstable, United Kingdom | |
| 1245.28.44016 Boehringer Ingelheim Investigational Site | |
| Blackpool, United Kingdom | |
| 1245.28.44021 Boehringer Ingelheim Investigational Site | |
| Bradford on Avon, United Kingdom | |
| 1245.28.44019 Boehringer Ingelheim Investigational Site | |
| Burbage, United Kingdom | |
| 1245.28.44027 Boehringer Ingelheim Investigational Site | |
| Chestfield, Whitstable, United Kingdom | |
| 1245.28.44011 Boehringer Ingelheim Investigational Site | |
| Chippenham, United Kingdom | |
| 1245.28.44022 Boehringer Ingelheim Investigational Site | |
| Chippenham, United Kingdom | |
| 1245.28.44043 Boehringer Ingelheim Investigational Site | |
| Coventry, United Kingdom | |
| 1245.28.44025 Boehringer Ingelheim Investigational Site | |
| Doncaster, United Kingdom | |
| 1245.28.44030 Boehringer Ingelheim Investigational Site | |
| Ely, United Kingdom | |
| 1245.28.44007 Boehringer Ingelheim Investigational Site | |
| Midsomer Norton, United Kingdom | |
| 1245.28.44023 Boehringer Ingelheim Investigational Site | |
| Nantwich, United Kingdom | |
| 1245.28.44017 Boehringer Ingelheim Investigational Site | |
| Whitstable, United Kingdom | |
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01167881 History of Changes |
| Other Study ID Numbers: | 1245.28 2009-016244-39 |
| Study First Received: | July 15, 2010 |
| Results First Received: | July 17, 2014 |
| Last Updated: | July 28, 2016 |
| Health Authority: | Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Austria: Medicines and Medical Devices Agency Canada: Health Canada Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Hong Kong: Department of Health India: Drugs Controller General of India Italy: Ethics Committee Malaysia: Ministry of Health Mexico: Federal Commission for Protection Against Health Risks Netherlands: Central Committee Research Involving Human Subjects Norway: Norwegian Medicines Agency Philippines: Bureau of Food and Drugs Portugal: National Pharmacy and Medicines Institute South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Taiwan : Food and Drug Administration Thailand: Ministry of Public 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Empagliflozin |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on September 23, 2016