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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01649297

First Posted: July 25, 2012

Last Update Posted: July 23, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim

Tracking Information

First Submitted Date ^ICMJE

July 23, 2012

First Posted Date ^ICMJE

July 25, 2012

Results First Submitted Date

June 26, 2015

Results First Posted Date

July 23, 2015

Last Update Posted Date

July 23, 2015

Start Date ^ICMJE

October 2012

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Change in glycated hemoglobin from baseline [ Time Frame: week 1 and week 16 ]

Change History

Complete list of historical versions of study NCT01649297 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Change in fasting plasma glucose from baseline [ Time Frame: week 1 and week 16 ]
Change in fasting plasma glucose by visit over time [ Time Frame: up to 16 weeks ]
Change in glycated hemoglobin by visit over time [ Time Frame: up to 16 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Drug: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Drug: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
Drug: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
Drug: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily

Study Arms

Experimental: empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
Interventions:
- Drug: Placebo
- Drug: Placebo
- Drug: Placebo
- Drug: Empagliflozin (high dose qd)
Experimental: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
Interventions:
- Drug: Placebo
- Drug: Placebo
- Drug: Placebo
- Drug: empagliflozin (high dose bid)
Experimental: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
Interventions:
- Drug: empagliflozin (low dose qd)
- Drug: Placebo
- Drug: Placebo
- Drug: Placebo
Experimental: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
Interventions:
- Drug: Placebo
- Drug: Placebo
- Drug: Placebo
- Drug: empagliflozin (low dose bid)
Placebo Comparator: Placebo
Patients receive placebo matching Empagliflozin
Interventions:
- Drug: Placebo
- Drug: Placebo
- Drug: Placebo
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

983

Completion Date

December 2013

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Canada, Estonia, France, Georgia, Germany, Guatemala, Italy, Latvia, Lithuania, Mexico, New Zealand, Poland, Russian Federation, South Africa, Spain, Ukraine, United States

Removed Location Countries

Turkey

Administrative Information

NCT Number ^ICMJE

NCT01649297

Other Study ID Numbers ^ICMJE

1276.10
2012-000905-53 ( EudraCT Number: EudraCT )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

PRS Account

Boehringer Ingelheim

Verification Date

June 2015

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

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