Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT01719003 |
Recruitment Status
:
Completed
First Posted
: November 1, 2012
Results First Posted
: February 19, 2016
Last Update Posted
: February 19, 2016
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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 | October 30, 2012 | |||
First Posted Date ICMJE | November 1, 2012 | |||
Results First Submitted Date | November 23, 2015 | |||
Results First Posted Date | February 19, 2016 | |||
Last Update Posted Date | February 19, 2016 | |||
Study Start Date ICMJE | October 2012 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 [ Time Frame: baseline and 24 weeks ] Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
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Original Primary Outcome Measures ICMJE |
Change from baseline in HbA1c [ Time Frame: 24 weeks ] | |||
Change History | Complete list of historical versions of study NCT01719003 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes | |||
Official Title ICMJE | A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus | |||
Brief Summary | This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment. | |||
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 |
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Intervention ICMJE |
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Study Arms |
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Publications * | Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4. | |||
* 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 |
1413 | |||
Original Estimated Enrollment ICMJE |
1424 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | November 2014 (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 | 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 | Brazil, Canada, Czech Republic, Egypt, France, Germany, Guatemala, Korea, Republic of, Lebanon, Malaysia, Mexico, Peru, Philippines, Russian Federation, Serbia, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States | |||
Removed Location Countries | India, Indonesia, United Arab Emirates | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01719003 | |||
Other Study ID Numbers ICMJE | 1276.1 2010-021375-92 ( EudraCT Number: EudraCT ) |
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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 | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |