| Outcome Measures: |
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 | Secondary: Fructosamine at End of Ramadan, The fructosamine values at the end of Ramadan (visit 12) were presented, 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., 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., 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., Baseline, day 29|Change From Baseline to End of Ramadan in Body Weight, 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), 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)|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)|Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period., 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, Day -1 to day 29
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| Locations: |
Novo Nordisk Investigational Site, Algiers, 16000, Algeria|Novo Nordisk Investigational Site, Constantine, 25000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Setif, 19000, Algeria|Novo Nordisk Investigational Site, Sidi Bel Abbes, 22000, Algeria|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500034, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380007, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560002, India|Novo Nordisk Investigational Site, Mysore, Karnataka, 570001, India|Novo Nordisk Investigational Site, Mysore, Karnataka, 570004, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400058, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411001, India|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Haifa, 35152, Israel|Novo Nordisk Investigational Site, Jerusalem, 93106, Israel|Novo Nordisk Investigational Site, Beirut, Lebanon|Novo Nordisk Investigational Site, Lebanon - Beirut, 9611, Lebanon|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Ipoh, Perak, 30990, Malaysia|Novo Nordisk Investigational Site, Klang, Selangor, 41200, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Putrajaya, 62250, Malaysia|Novo Nordisk Investigational Site, Selangor Darul Ehsan, 68000, Malaysia|Novo Nordisk Investigational Site, Seremban, Negeri Sembilan, 70400, Malaysia|Novo Nordisk Investigational Site, Benoni, Gauteng, 1501, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1812, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Lenasia, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0181, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4091, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4092, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4450, South Africa|Novo Nordisk Investigational Site, Ajman, 21499, United Arab Emirates|Novo Nordisk Investigational Site, Dubai, 4545, United Arab Emirates|Novo Nordisk Investigational Site, Dubai, 9115, United Arab Emirates|Novo Nordisk Investigational Site, Ras Al Khaimah, 4727, United Arab Emirates|Novo Nordisk Investigational Site, Sharjah, 3500, United Arab Emirates|Novo Nordisk Investigational Site, Umm Al Quwain, 24, United Arab Emirates
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