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 has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: January 14, 2014
Last verified: January 2014
  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 evaluate whether a twice daily dose regimen of empagliflozin results 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:

Primary Outcome Measures:
  • Change in glycated hemoglobin from baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose from baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 983
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 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:

  1. confirmed diagnosis of T2DM
  2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
  3. Metformin therapy (at least 1500 mg/day, BID)
  4. age>=18 at Visit 1
  5. body mass index <=45 kg/m2

Exclusion criteria:

  1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
  2. 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

  Show 139 Study Locations
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: NCT01649297     History of Changes
Other Study ID Numbers: 1276.10, 2012-000905-53
Study First Received: July 23, 2012
Last Updated: January 14, 2014
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 April 16, 2014