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Clinical Trial Details

Trial ID: L3565
Source ID: NCT02941367
Associated Drug: Lixisenatide (Ave0010)
Title: Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan
Acronym: LixiRam
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Lixisenatide (AVE0010)|DRUG: Sulfonylurea|DRUG: metformin|DRUG: basal insulin
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
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 184
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-02-23
Completion Date: 2017-08-04
Results First Posted:
Last Update Posted: 2022-04-25
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
URL: https://clinicaltrials.gov/show/NCT02941367