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 - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 144 Study Locations

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:	May 15, 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 May 16, 2013