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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01719003
First received: October 30, 2012
Last updated: September 3, 2014
Last verified: September 2014
  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: Metformin 500 mg bid
Drug: Metformin 1000 mg bid
Drug: Empagliflozin low dose qd
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:


Further study details as provided by Boehringer Ingelheim:

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: 1397
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. 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
  3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
  4. Body Mass Index (BMI) <= 45 kg/m2 at screening

Exclusion criteria:

  1. 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)
  2. Any antidiabetic drug within 12 weeks prior to randomization
  3. 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
  4. Contraindications to metformin according to the local label
  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: NCT01719003

  Show 193 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: NCT01719003     History of Changes
Other Study ID Numbers: 1276.1, 2010-021375-92
Study First Received: October 30, 2012
Last Updated: September 3, 2014
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
Lebanon: Institutional Review Board
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 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 September 15, 2014