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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 Intervention Model: Parallel Assignment Masking: Double 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 ]
Secondary Outcome Measures:
- The Change in Body Weight From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Change From Baseline in HbA1c After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Change in Body Weight From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
| 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) |
| Sexes Eligible for Study: | All |
| 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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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 ( EudraCT Number: EudraCT ) |
| Study First Received: | July 15, 2010 |
| Results First Received: | July 17, 2014 |
| Last Updated: | July 28, 2016 |
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 August 23, 2017