drugset / Trial / NCT03804411
Prognostic Predictors of Response to Hypoglycemic Therapy
Phase 4
Unknown
800 enrolled
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
RandomizedParallel-groupSingle-blindBasic science
Summary
This is a randomized controlled trial aimed to determine highly specific personified predictors of response to the therapy by different groups of hypoglycemic drugs (SGLT-2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, sulfonylureas) in patients with type 2 diabetes mellitus, develop an algorithm of personalized therapy based on them, design an organizational and methodological model for prevention of the cardiovascular complications, and create an automated decision-making system for therapy selection to reduce the incidence of cardiovascular events and related adverse outcomes compared to the traditional approach. This is an interventional, randomized controlled trial, open-label study.
Timeline
- Start
- 2017-08-01
- Primary completion
- 2020-03
- Completion
- 2020-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | — |
| Subject | Empagliflozin | Small molecule | 10 mg | — |
| Subject | Exenatide | Peptide | 20 ug | — |
| Subject | Gliclazide | Small molecule | — | — |
| Subject | Glimepiride | Small molecule | — | — |
| Subject | Liraglutide | Peptide | 1.2 mg | — |
| Subject | Liraglutide | Peptide | 1.8 mg | — |
| Subject | Sitagliptin | Small molecule | 100 mg | — |
| Subject | Vildagliptin | Other / unclassified | 100 mg | — |