Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01368081 |
Recruitment Status
:
Completed
First Posted
: June 7, 2011
Results First Posted
: June 17, 2014
Last Update Posted
: June 17, 2014
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Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
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Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01368081 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Change From Baseline in HbA1c [ Time Frame: Baseline and 52 weeks ] Change from baseline in HbA1c after 52 weeks of treatment
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Original Secondary Outcome Measures ICMJE |
Change from baseline in HbA1c after 52 weeks of treatment [ Time Frame: Baseline and 52 weeks ] | |||
Current Other Outcome Measures ICMJE |
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
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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 |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1162 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion criteria:
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Sex/Gender |
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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 |
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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 |