Clinical Trial Details
| Trial ID: | L6593 |
| Source ID: | NCT04916093 |
| Associated Drug: | Vildagliptin 50 Mg |
| Title: | Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Vildagliptin 50 MG|DRUG: Sitagliptin 100mg|DRUG: MetFORMIN 1000 Mg Oral Tablet |
| Outcome Measures: | Primary: Changes in glycemic parameters, serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl), 3-months|Changes in Serum insulin (IU/l), using enzyme immunoassay (EIA) kits, 3-months|Insulin resistance, measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405, 3-months|Beta cell function (HOMA-B), measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63), 3-months|Changes in HbA1c (%), Changes in HbA1c (%), 3-months | Secondary: Changes in Lipid profile, (total cholesterol, TG, HDL, and LDL) (mg/dl), 3-months|Changes in liver enzymes, ALT and AST (U/l), 3-months|Changes in Renal function tests, creatinine and urea (mg/dl), 3-months |
| Sponsor/Collaborators: | Sponsor: Beni-Suef University | Collaborators: Minia University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 60 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT |
| Start Date: | 2019-12-20 |
| Completion Date: | 2020-12-15 |
| Results First Posted: | |
| Last Update Posted: | 2021-06-07 |
| Locations: | Minya University Hospital, Minya, 61118, Egypt |
| URL: | https://clinicaltrials.gov/show/NCT04916093 |
