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: March 27, 2014
Last verified: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: 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: March 27, 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

ClinicalTrials.gov processed this record on October 01, 2014