| Outcome Measures: |
Primary: Change in HbA1c (%) (Glycosylated Haemoglobin), Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan)., From week 0 to end of Ramadan (day 29 of Ramadan) | Secondary: Change in Fasting Plasma Glucose (FPG), Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan)., From week 0 to end of Ramadan (day 29 of Ramadan)|Change in Fructosamine, Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan)., From week 0 to end of Ramadan (day 29 of Ramadan)|Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target ), Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan)., End of Ramadan (day 29 of Ramadan)|Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target), Number of subjects who achieved FPG \<=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG., End of Ramadan (day 29 of Ramadan)|Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic, Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product. The above mentioned definitions (in endpoint title) should read as the following: Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL). Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure., From week 0 to 4 weeks post Ramadan|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes, Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive. Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration., From week 0 to 4 weeks post Ramadan
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| Locations: |
Novo Nordisk Investigational Site, Algiers, 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, 500 001, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500058, India|Novo Nordisk Investigational Site, Mysore, Karnataka, 570001, India|Novo Nordisk Investigational Site, Kozhikode, Kerala, 673017, 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, Kolkatta, West Bengal, 700073, India|Novo Nordisk Investigational Site, New Delhi, 110001, India|Novo Nordisk Investigational Site, Beirut, Lebanon|Novo Nordisk Investigational Site, Hazmieh, Lebanon|Novo Nordisk Investigational Site, Lebanon - Beirut, 9611, Lebanon|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, 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, Cape Town, Western Cape, 7925, South Africa|Novo Nordisk Investigational Site, Ajman, 21499, United Arab Emirates|Novo Nordisk Investigational Site, Ajman, 4184, United Arab Emirates|Novo Nordisk Investigational Site, Dubai, 7272, United Arab Emirates|Novo Nordisk Investigational Site, Umm Al Quwain, 24, United Arab Emirates
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