Skip to main content
OpenTrials
Completed

NCT Number: NCT01649297

A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1276.10.61002 Boehringer Ingelheim Investigational Site, Wollongong, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of T2DM
  • Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
  • Metformin therapy (at least 1500 mg/day, BID)
  • age>=18 at Visit 1
  • body mass index <=45 kg/m2

Exclusion criteria

  • estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
  • a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

Treatment and study plan

Placebo

Drug

Patients receive placebo matching empagliflozin (low dose qd)

empagliflozin (low dose qd)

Drug

Patients receive Empagliflozin low dose once daily

Empagliflozin (high dose qd)

Drug

Patients receive Empagliflozin high dose once daily

empagliflozin (high dose bid)

Drug

Patients receive Empagliflozin high dose split twice daily

empagliflozin (low dose bid)

Drug

Patients receive Empagliflozin low dose split twice daily

Primary outcomes

  1. HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16

    Time frame: Baseline and 16 weeks

    Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.

    Means provided are the adjusted means.

Secondary outcomes

  1. Fasting Plasma Glucose (FPG) Change From Baseline at Week 16

    Time frame: Baseline and 16 weeks

    Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.

    Means provided are the adjusted means.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2012
Registry last updated
Jul 23, 2015

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.