A clinical trial to study the effects of two drugs, Metformin and Sitagliptin as adjunct to insulin therapy on glycemic control in non obese adolescent patients with type 1 diabetes mellitus

INTERVENTION: Intervention1: Insulin Therapy Continued in all three groups Group 1‐ Metformin 500 mg OD orally for three months: Insulin Therapy Continued in all three groups Group 1‐ Metformin 500 mg OD orally for three months Intervention2: Tab Sitagliptin 50 mg OD for 3 months: Insulin as advised for treatment and intervention as Tab sitagliptin for 3 months OD Control Intervention1: Control group ‐ No intervention will continue as per standard insulin therapy only: Control group ‐ No intervention No intervention will continue with standard insulin thearapy For 3 months CONDITION: Health Condition 1: E108‐ Type 1 diabetes mellitus with unspecified complications PRIMARY OUTCOME: PRIMARY OBJECTIVES: ; 1. To determine change in HbA1c levels from baseline to study endpoint ; 2. To determine change in daily insulin requirements from baseline to the endpoint ; ; Timepoint: 6 months ‐Reruitment ; 3 months intervention ; 3 months data analysis ; SECONDARY OUTCOME: 1.The change in fasting and mean blood glucose levels from study entry to endpoint ; 2.The change in HOMA‐IR from baseline to endpoint ; 3.The change in C‐peptide levels from baseline to endpoint ; 4.The change in glycemic variability from baseline to endpoint ; 5.The change in the number of hypoglycemic events from baseline to study endpoint ; Timepoint: 6 months ‐Reruitment ; 3 months intervention ; 3 months data analysis INCLUSION CRITERIA: 1 Age:10‐16 years 2 Diagnosis of T1D based on revised ISPAD (The 3 International Society for Pediatric and Adolescent Diabetes) criteria 4 At least one pancreatic autoantibody positivity and low C‐peptide levels 5 Children on basal‐bolus insulin regimen (glargine as long‐acting and either lispro or aspart as short acting insulins) HbA1c â?Â¥7.5%