This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: June 26, 2015
Last verified: June 2015
July 23, 2012
June 26, 2015
October 2012
December 2013   (Final data collection date for primary outcome measure)
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.

Change in glycated hemoglobin from baseline [ Time Frame: week 1 and week 16 ]
Complete list of historical versions of study NCT01649297 on ClinicalTrials.gov Archive Site
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.

  • 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 ]
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
983
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion criteria:

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

Exclusion criteria:

  1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
  2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Estonia,   France,   Georgia,   Germany,   Guatemala,   Italy,   Latvia,   Lithuania,   Mexico,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Turkey
 
NCT01649297
1276.10
2012-000905-53 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2015

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