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

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
Study Start Date ICMJE	October 2012
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 26, 2015)	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; (submitted: July 23, 2012)	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; (submitted: June 26, 2015)	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; (submitted: July 23, 2012)	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
Actual Enrollment ICMJE; (submitted: August 7, 2013)	983
Original Estimated Enrollment ICMJE; (submitted: July 23, 2012)	936
Actual Study Completion Date	December 2013
Actual 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	No
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 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