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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
343
1.8 mg administered subcutaneously (s.c., under the skin) once daily
Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
Subjects will continue on their pre-trial SU tablet treatment, doses unchanged
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).
Time frame: Day -1, day 29
Fructosamine at End of Ramadan
The fructosamine values at the end of Ramadan (visit 12) were presented
Time frame: Day 29
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.
Time frame: Day -1, day 29
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.
Time frame: Baseline, day 29
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.
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)
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Novo Nordisk Investigational Site
Algiers, Algeria
Novo Nordisk Investigational Site
Constantine, Algeria
Novo Nordisk Investigational Site
Oran, Algeria
Novo Nordisk Investigational Site
Sétif, Algeria
Novo Nordisk Investigational Site
Sidi Bel Abbes, Algeria
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India
Novo Nordisk Investigational Site
Mysore, Karnataka, India
Novo Nordisk Investigational Site
Mysore, Karnataka, India
...and 31 more locations
Subjects who at end of treatment (Visit 14, 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 (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)
Time frame: Visit 14 (4 weeks post Ramadan)
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.
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
Time frame: Day -1 to day 29