Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Tracking Information
First Submitted Date ICMJE	May 19, 2011
First Posted Date ICMJE	June 7, 2011
Results First Submitted Date	May 16, 2014
Results First Posted Date	June 17, 2014
Last Update Posted Date	June 17, 2014
Study Start Date ICMJE	May 2011
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 16, 2014)	Number of Patients With Drug Related Adverse Events [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ]; Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Original Primary Outcome Measures ICMJE; (submitted: June 6, 2011)	Frequency of number of adverse events [ Time Frame: 52 weeks ]; Frequency of hypoglycaemic events [ Time Frame: 52 weeks ]; Frequency of protocol specified significant adverse events (decreased renal function and hepatic injury) [ Time Frame: 52 weeks ]; Frequency of cardiovascular events (defined based on adjudication results of clinical event committee) [ Time Frame: 52 weeks ]; Change from baseline in vital signs (blood pressure and pulse rate) [ Time Frame: Baseline and 52 weeks at the maximum ]; Change from baseline in laboratory values [ Time Frame: Baseline and 52 weeks at the maximum ]
Change History	Complete list of historical versions of study NCT01368081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 16, 2014)	Change From Baseline in HbA1c [ Time Frame: Baseline and 52 weeks ]; Change from baseline in HbA1c after 52 weeks of treatment
Original Secondary Outcome Measures ICMJE; (submitted: June 6, 2011)	Change from baseline in HbA1c after 52 weeks of treatment [ Time Frame: Baseline and 52 weeks ]
Current Other Outcome Measures ICMJE; (submitted: May 16, 2014)	Confirmed Hypoglycaemic Adverse Events [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ]; Number of patients with confirmed hypoglycaemic adverse events
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Official Title ICMJE	A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Brief Summary	The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus, Type 2
Intervention ICMJE	Drug: Metformin Metformin tablets 500-2250 mg a day (twice or three times per day); Drug: BI 10773 BI 10773 low dose tablet once daily; Drug: Placebo (low dose) Placebo tablets once daily; Drug: BI 10773 BI 10773 high dose tablet once daily; Drug: Placebo (high dose) Placebo tablets once daily
Study Arms	Experimental: BI 10773 low dose BI 10773 low dose tablet once daily Interventions: Drug: BI 10773 Drug: Placebo (high dose); Experimental: BI 10773 high dose BI 10773 high dose tablet once daily Interventions: Drug: Placebo (low dose) Drug: BI 10773; Active Comparator: Metformin Metformin tablets 500-2250 mg a day (twice or three times per day) Intervention: Drug: Metformin
Publications *	Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.; Araki E, Tanizawa Y, Tanaka Y, Taniguchi A, Koiwai K, Kim G, Salsali A, Woerle HJ, Broedl UC. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665-74. doi: 10.1111/dom.12464. Epub 2015 Apr 15.
* 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: April 30, 2013)	1162
Original Estimated Enrollment ICMJE; (submitted: June 6, 2011)	1071
Actual Study Completion Date	April 2013
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion criteria: .Diagnosis of type 2 diabetes mellitus prior to informed consent; Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione; glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program) Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L); Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent; Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Sex/Gender	Sexes Eligible for Study: All
Ages	20 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	Japan
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01368081
Other Study ID Numbers ICMJE	1245.52
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	May 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP