| Outcome Measures: |
Primary: Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L), Approximately 30 days (from start to end of Ramadan holy month) | Secondary: Mean change in HbA1c, Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan|Mean change in body weight, Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan|Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L), Last 14 days of Ramadan month|Percentage of patients with HbA1C <7%, At 0-4 weeks pre- and 0-4 weeks post-Ramadan|Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L), At pre-Ramadan visit|Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L), At 0-4 weeks pre- and 0-4 weeks post-Ramadan
|
| Locations: |
Investigational Site Number 356005, Ahmedabad, 380007, India|Investigational Site Number 356002, Bangalore, 560043, India|Investigational Site Number 356015, Bangalore, 560055, India|Investigational Site Number 356008, Bangalore, 560060, India|Investigational Site Number 356009, Hyderabad, 500001, India|Investigational Site Number 356018, Hyderabad, 500004, India|Investigational Site Number 356010, Hyderabad, 500072, India|Investigational Site Number 356003, Hyderabad, 500095, India|Investigational Site Number 356007, Jaipur, India|Investigational Site Number 356019, Madurai, 625020, India|Investigational Site Number 356014, Mumbai, 400007, India|Investigational Site Number 356022, Nagpur, 440010, India|Investigational Site Number 376001, Haifa, 31096, Israel|Investigational Site Number 376002, Safed, 13100, Israel|Investigational Site Number 414001, Kuwait, Kuwait|Investigational Site Number 792002, Zonguldak, Turkey
|