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 19, 2014
Last verified: September 2014

October 30, 2012
September 19, 2014
October 2012
November 2014   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01719003 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Hyperglycemia
  • Drug: Metformin 500 mg bid
    Metformin 500 mg twice daily
  • Drug: Metformin 1000 mg bid
    Metformin 1000 mg twice daily
  • Drug: Empagliflozin low dose qd
    Empagliflozin low dose once daily
  • Drug: Empagliflozin high dose qd
    Empagliflozin high dose once daily
  • Drug: Empagliflozin low dose bid
    Empagliflozin low dose split twice daily
  • Drug: Empagliflozin high dose bid
    Empagliflozin high dose split twice daily
  • Experimental: Empagliflozin low dose qd
    Empagliflozin low dose once daily
    Intervention: Drug: Empagliflozin low dose qd
  • Experimental: Empagliflozin high dose qd
    Empagliflozin high dose once daily
    Intervention: Drug: Empagliflozin high dose qd
  • 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.
    Interventions:
    • Drug: Metformin 1000 mg bid
    • Drug: Empagliflozin high dose bid
  • Experimental: Empagliflozin low dose + met 500 mg bid
    Empagliflozin low dose split twice daily + metformin 500 mg twice daily
    Interventions:
    • Drug: Metformin 500 mg bid
    • Drug: Empagliflozin low dose bid
  • Experimental: Empagliflozin low dose + met 1000 mg bid
    Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
    Interventions:
    • Drug: Empagliflozin low dose bid
    • Drug: Metformin 1000 mg bid
  • Experimental: Empagliflozin high dose + met 500 mg bid
    Empagliflozin high dose split twice daily + metformin 500 mg twice daily
    Interventions:
    • Drug: Metformin 500 mg bid
    • Drug: Empagliflozin high dose bid
  • Experimental: Empagliflozin high dose + met 1000mg bid
    Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
    Interventions:
    • Drug: Metformin 1000 mg bid
    • Drug: Empagliflozin high dose bid
  • Experimental: Metformin 500 mg bid
    Metformin 500 mg twice daily
    Intervention: Drug: Metformin 500 mg bid
  • Experimental: Metformin 1000 mg bid
    Metformin 1000 mg twice daily
    Intervention: Drug: Metformin 1000 mg bid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1397
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada,   Czech Republic,   Egypt,   France,   Germany,   Guatemala,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Peru,   Philippines,   Russian Federation,   Serbia,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01719003
1276.1, 2010-021375-92
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP