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

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ClinicalTrials.gov Identifier: NCT01719003
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 [ Time Frame: baseline and 24 weeks ]
    Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means


Secondary Outcome Measures :
  1. FPG (Fasting Plasma Glucose) Change From Baseline at Week 24 [ Time Frame: baseline and 24 weeks ]
    Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.

  2. Body Weight Change From Baseline at Week 24 [ Time Frame: baseline and 24 weeks ]
    Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719003


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01719003    
Other Study ID Numbers: 1276.1
2010-021375-92 ( EudraCT Number: EudraCT )
First Posted: November 1, 2012    Key Record Dates
Results First Posted: February 19, 2016
Last Update Posted: February 19, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Metformin
Empagliflozin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action