Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01167881
First received: July 15, 2010
Last updated: May 15, 2013
Last verified: May 2013
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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 Pharmaceuticals:
Primary Outcome Measures:
- The change from baseline in HbA1c after 52 weeks of treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The change from baseline in 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 52 weeks of treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The occurrence of hypoglycaemic events during 52 weeks of treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The change in blood pressure (SBP and DBP ) from baseline after 52 weeks of treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- The change in body weight from baseline after 104 weeks of treatment. [ Time Frame: baseline and 104weeks ] [ Designated as safety issue: No ]
- The occurrence of hypoglycaemic events during 104 weeks of treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
- The change in blood pressure (SBP and DBP ) from baseline after 104 weeks of treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
- Incidence of Adverse events [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: Yes ]
- Incidence of Adverse events [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: Yes ]
- Occurrence of adverse events of protocol specific significant AEs [ Time Frame: 52 ] [ Designated as safety issue: Yes ]
- Occurrence of adverse events of protocol specific significant AEs [ Time Frame: 104 ] [ Designated as safety issue: Yes ]
- Occurrence of Hypoglycaemic events [ Time Frame: 52 ] [ Designated as safety issue: Yes ]
- Occurrence of Hypoglycaemic events [ Time Frame: 104 ] [ Designated as safety issue: Yes ]
- Occurrence of Cardiovascular events (Clinical Event Committee adjudication results) [ Time Frame: 52 ] [ Designated as safety issue: Yes ]
- Occurrence of Cardiovascular events (Clinical Event Committee adjudication results) [ Time Frame: 104 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1549 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | July 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
1) Diagnosis typ 2 diabetes mellitus, 2) male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation, 3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1, 4) 18 years or more, 5) BMI equal or less than 45Kg/m2.
Exclusion criteria:
1) uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in, 2) any other antidiabetic drug within 12 weeks prior to randomisation except metformin,3) acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent,4) indication liver disease, 5) moderate to severe renal impairment, 6) bariatric surgery within past 2 years, 7) medical history of cancer or treatment for cancer within last 5 years, 8) blood dyscrasias or any disorders causing haemolysis or unstable red blood cell, 9) contraindications hypersensitivity to concomitant drugs,10) treatment with anti-obesity drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167881
Show 182 Study Locations
Show 182 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01167881 History of Changes |
| Other Study ID Numbers: | 1245.28, 2009-016244-39 |
| Study First Received: | July 15, 2010 |
| Last Updated: | May 15, 2013 |
| 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: 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 Metformin Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013