Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes (LIRA-Ramadan™)
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ClinicalTrials.gov Identifier: NCT01917656 |
Recruitment Status
:
Completed
First Posted
: August 7, 2013
Results First Posted
: October 7, 2015
Last Update Posted
: August 24, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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Tracking Information | ||||
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First Submitted Date ICMJE | July 29, 2013 | |||
First Posted Date ICMJE | August 7, 2013 | |||
Results First Submitted Date | September 2, 2015 | |||
Results First Posted Date | October 7, 2015 | |||
Last Update Posted Date | August 24, 2017 | |||
Actual Study Start Date ICMJE | January 9, 2014 | |||
Actual Primary Completion Date | September 1, 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in Fructosamine From Start of Ramadan to End of Ramadan [ Time Frame: Day -1, day 29 ] The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).
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Original Primary Outcome Measures ICMJE |
Change in Fructosamine From Start of Ramadan to End of Ramadan [ Time Frame: Day -1, day 29 ] | |||
Change History | Complete list of historical versions of study NCT01917656 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 | Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes | |||
Official Title ICMJE | Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes | |||
Brief Summary | This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) 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 * | Azar ST, Echtay A, Wan Bebakar WM, Al Araj S, Berrah A, Omar M, Mutha A, Tornøe K, Kaltoft MS, Shehadeh N. Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial. Diabetes Obes Metab. 2016 Oct;18(10):1025-33. doi: 10.1111/dom.12733. Epub 2016 Aug 18. | |||
* 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 |
343 | |||
Original Estimated Enrollment ICMJE |
320 | |||
Actual Study Completion Date | September 4, 2014 | |||
Actual Primary Completion Date | September 1, 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 | Algeria, India, Israel, Lebanon, Malaysia, South Africa, United Arab Emirates | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01917656 | |||
Other Study ID Numbers ICMJE | NN2211-3987 U1111-1132-9716 ( Other Identifier: WHO ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novo Nordisk A/S | |||
Study Sponsor ICMJE | Novo Nordisk A/S | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novo Nordisk A/S | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |