A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
This study is currently recruiting participants.
Verified June 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: June 13, 2013
Last verified: June 2013
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Purpose
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to demonstrate that a twice daily dose regimen of empagliflozin does not result in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Placebo Drug: empagliflozin (low dose qd) Drug: Empagliflozin (high dose qd) Drug: empagliflozin (high dose bid) Drug: empagliflozin (low dose bid) |
Phase 2 |
| 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 Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Change in glycated hemoglobin from baseline [ Time Frame: week 1 and week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in fasting plasma glucose from baseline [ Time Frame: week 1 and week 16 ] [ Designated as safety issue: No ]
- Change in fasting plasma glucose by visit over time [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
- Change in glycated hemoglobin by visit over time [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 936 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
|
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
|
|
Experimental: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
|
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
|
|
Experimental: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
|
Drug: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
|
|
Experimental: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
|
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
|
|
Placebo Comparator: Placebo
Patients receive placebo matching Empagliflozin
|
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- confirmed diagnosis of T2DM
- Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
- Metformin therapy (at least 1500 mg/day, BID)
- age>=18 at Visit 1
- body mass index <=45 kg/m2
Exclusion criteria:
- estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
- a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649297
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Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Ukraine | |
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| Kharkiv, Ukraine | |
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| Kyiv, Ukraine | |
Sponsors 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: | NCT01649297 History of Changes |
| Other Study ID Numbers: | 1276.10, 2012-000905-53 |
| Study First Received: | July 23, 2012 |
| Last Updated: | June 13, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee Canada: Health Canada Estonia: The State Agency of Medicine France: Agence Nationale sécurité médicament et des produits santé Georgia: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Guatemala: Ministry of Public Health and Social Assistance Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Mexico: Federal Commission for Sanitary Risks Protection New Zealand: Health and Disability Ethics Committees Poland: Registration Medicinal Product Medical Device Biocidal Product Russia: Pharmacological Committee, Ministry of Health South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Ukraine: State Pharmacological Center - Ministry of Health United States: Federal Government United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013