Skip to main content
OpenTrials
Completed

NCT Number: NCT01719003

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1276.1.55008 Boehringer Ingelheim Investigational Site, Belém, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin 500 mg bid

Drug

Metformin 500 mg twice daily

Metformin 1000 mg bid

Drug

Metformin 1000 mg twice daily

Empagliflozin low dose qd

Drug

Empagliflozin low dose once daily

Empagliflozin high dose qd

Drug

Empagliflozin high dose once daily

Empagliflozin low dose bid

Drug

Empagliflozin low dose split twice daily

Empagliflozin high dose bid

Drug

Empagliflozin high dose split twice daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.