Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— LIRA-Ramadan™  

Official title:

Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917656
• Other study ID #: NN2211-3987
• Secondary ID: U1111-1132-9716
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2013
• Last updated: November 10, 2015
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Algeria: Ministry of HealthIndia: Drugs Controller General of IndiaIsrael: Ministry of HealthLebanon: Ministry of Public HealthMalaysia: Ministry of HealthSouth Africa: Medicines Control CouncilUnited Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
1.8 mg administered subcutaneously (s.c., under the skin) once daily
• metformin
Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
• sulfonylurea
Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fructosamine From Start of Ramadan to End of Ramadan	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).	Day -1, day 29	No
Secondary	Fructosamine at End of Ramadan	The fructosamine values at the end of Ramadan (visit 12) were presented	Day 29	No
Secondary	Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)	The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.	Day -1, day 29	No
Secondary	Change From Baseline to End of Ramadan in Fasting Plasma Glucose	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.	Baseline, day 29	No
Secondary	Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)	The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.	Baseline, day 29	No
Secondary	Change From Baseline to End of Ramadan in Body Weight		Baseline, day 29	No
Secondary	Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)	Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)	Visit 14 (4 weeks post Ramadan)	No
Secondary	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	Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)	Visit 14 (4 weeks post Ramadan)	No
Secondary	Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.		Day -1 to day 29	No
Secondary	Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.	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	Day -1 to day 29	No

External Links

•   Clinical Trials at Novo Nordisk