Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes (LIRA-Ramadan™)

Tracking Information
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; (submitted: November 10, 2015)	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).
Original Primary Outcome Measures ICMJE; (submitted: August 6, 2013)	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; (submitted: November 10, 2015)	Fructosamine at End of Ramadan [ Time Frame: Day 29 ]The fructosamine values at the end of Ramadan (visit 12) were presented; Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG) [ Time Frame: Day -1, day 29 ]The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.; Change From Baseline to End of Ramadan in Fasting Plasma Glucose [ Time Frame: Baseline, day 29 ]The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.; Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Baseline, day 29 ]The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.; Change From Baseline to End of Ramadan in Body Weight [ Time Frame: Baseline, day 29 ]; Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target) [ Time Frame: Visit 14 (4 weeks post Ramadan) ]Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target); Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes [ Time Frame: Visit 14 (4 weeks post Ramadan) ]Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target); Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period. [ Time Frame: Day -1 to day 29 ]; Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period. [ Time Frame: Day -1 to day 29 ]A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events. Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable
Original Secondary Outcome Measures ICMJE; (submitted: August 6, 2013)	Fructosamine at End of Ramadan [ Time Frame: Day 29 ]; Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG) [ Time Frame: Day -1, day 29 ]; Change from baseline to end of Ramadan in FPG [ Time Frame: Baseline, day 29 ]; Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Baseline, day 29 ]; Change From Baseline to End of Ramadan in Body Weight [ Time Frame: Baseline, day 29 ]; Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target) [ Time Frame: Day 29 ]; Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes [ Time Frame: Day 29 ]; Number of confirmed hypoglycaemic episodes [ Time Frame: Day -1 to day 29 ]; Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day -1 to day 29 ]
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
Condition ICMJE	Diabetes; Diabetes Mellitus, Type 2
Intervention ICMJE	Drug: liraglutide 1.8 mg administered subcutaneously (s.c., under the skin) once daily; Drug: metformin Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged; Drug: sulphonylurea Subjects will continue on their pre-trial SU tablet treatment, doses unchanged
Study Arms	Experimental: Liraglutide+Metformin Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. Interventions: Drug: liraglutide Drug: metformin; Active Comparator: Sulphonylurea and Metformin Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose. Interventions: Drug: metformin Drug: sulphonylurea
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 5, 2014)	343
Original Estimated Enrollment ICMJE; (submitted: August 6, 2013)	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: - Subjects diagnosed with T2DM and treated with metformin equal to or above 1000 mg/day and SU (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose; - HbA1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive); - Body Mass Index (BMI) equal to or above 20 kg/m^2; - Subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting Exclusion Criteria: - Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour); - Any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol; - History of chronic pancreatitis or idiopathic acute pancreatitis; - Screening calcitonin value equal to or above 50 ng/L; - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2); - Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL); - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula); - Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening; - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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 )
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	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
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