Clinical Trial Details
| Trial ID: | L1986 |
| Source ID: | NCT04654676 |
| Associated Drug: | Vildagliptin |
| Title: | DPP4 Inhibitor on Glycemic Variability |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Vildagliptin |
| Outcome Measures: | Primary: Changes in mean amplitude of glycemic excursions in mmol/L, Standard deviation of the mean glucose levels in mmol/L, M value in mmol/L, Mean absolute glucose in mmol/L, Continuous overlapping net glycemic action in mmol/L, Lability index in mmol/L, Glycemic variability, 12 months | Secondary: Estimated HbA1c in %, % time in range (TIR) in %, % time above range (TAR) in %, % time below range (TBR) in %, % time below 3.0 mmol/L in %, Glycemic control, 12 months|Low blood glucose index (LBGI) in mmol/L, High blood glucose index (HBGI) in mmol/L, Glycemic control, 12 months|Area under curve above 10.0mmol/day, area under curve below 3.9mmol/day, Glycemic control, 12 months |
| Sponsor/Collaborators: | Sponsor: University Malaysia Sarawak | Collaborators: Sarawak General Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 12 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2018-09-15 |
| Completion Date: | 2019-08-31 |
| Results First Posted: | |
| Last Update Posted: | 2020-12-19 |
| Locations: | Sarawak General Hospital, Kuching, Malaysia |
| URL: | https://clinicaltrials.gov/show/NCT04654676 |
