Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes - Full Text View

Purpose

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Hyperglycemia	Drug: Empagliflozin low dose qd Drug: Metformin 500 mg bid Drug: Metformin 1000 mg bid Drug: Empagliflozin high dose qd Drug: Empagliflozin low dose bid Drug: Empagliflozin high dose bid	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 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Hyperglycemia

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose (FPG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1364
Study Start Date:	October 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Empagliflozin low dose qd Empagliflozin low dose once daily	Drug: Empagliflozin low dose qd Empagliflozin low dose once daily
Experimental: Empagliflozin high dose qd Empagliflozin high dose once daily	Drug: Empagliflozin high dose qd Empagliflozin high dose once daily
Experimental: OL empa high dose + met 1000 mg bid Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.	Drug: Metformin 1000 mg bid Metformin 1000 mg twice daily Drug: Empagliflozin high dose bid Empagliflozin high dose split twice daily
Experimental: Empagliflozin low dose + met 500 mg bid Empagliflozin low dose split twice daily + metformin 500 mg twice daily	Drug: Metformin 500 mg bid Metformin 500 mg twice daily Drug: Empagliflozin low dose bid Empagliflozin low dose split twice daily
Experimental: Empagliflozin low dose + met 1000 mg bid Empagliflozin low dose split twice daily + metformin 1000 mg twice daily	Drug: Empagliflozin low dose bid Empagliflozin low dose split twice daily Drug: Metformin 1000 mg bid Metformin 1000 mg twice daily
Experimental: Empagliflozin high dose + met 500 mg bid Empagliflozin high dose split twice daily + metformin 500 mg twice daily	Drug: Metformin 500 mg bid Metformin 500 mg twice daily Drug: Empagliflozin high dose bid Empagliflozin high dose split twice daily
Experimental: Empagliflozin high dose + met 1000mg bid Empagliflozin high dose split twice daily + metformin 1000 mg twice daily	Drug: Metformin 1000 mg bid Metformin 1000 mg twice daily Drug: Empagliflozin high dose bid Empagliflozin high dose split twice daily
Experimental: Metformin 500 mg bid Metformin 500 mg twice daily	Drug: Metformin 500 mg bid Metformin 500 mg twice daily
Experimental: Metformin 1000 mg bid Metformin 1000 mg twice daily	Drug: Metformin 1000 mg bid Metformin 1000 mg twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
Body Mass Index (BMI) <= 45 kg/m2 at screening

Exclusion criteria:

Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
Any antidiabetic drug within 12 weeks prior to randomization
Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
Contraindications to metformin according to the local label

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719003

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 190 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:	NCT01719003 History of Changes
Other Study ID Numbers:	1276.1, 2010-021375-92
Study First Received:	October 30, 2012
Last Updated:	May 15, 2013
Health Authority:	Brazil: Ministry of Health Canada: Health Canada Czech Republic: State Institute for Drug Control Egypt: Ministry of Health, Drug Policy and Planning Center France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Guatemala: Ministry of Public Health and Social Assistance India: Drugs Controller General of India Indonesia: Lebanon: Ministry of Public Health Malaysia: Ministry of Health Mexico: Ministry of Health Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Russia: Pharmacological Committee, Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices South Korea: Ministry of Food and Drug Safety (MFDS) Spain: Spanish Agency of Medicines Taiwan: Department of Health Thailand: Food and Drug Administration Turkey: Ministry of Health United Arab. Emirates: United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013