drugset / Trial / NCT04027023
Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus
NaSingle-groupOpen-labelTreatment
Summary
This phase IV study is a prospective open-label multi-center study to investigate the effect of a temporary individualized poly-pharmaceutical De-escalation treatment with the target to regenerate ß-cell function over 12 weeks on the disease stage and glycemic control in patients with type 2 diabetes. This is an uncontrolled pilot study to collect data for later confirmatory trials.
Timeline
- Start
- 2019-10-30
- Primary completion
- 2021-04-30
- Completion
- 2021-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 100 mg | — |
| Subject | Dapagliflozin | Small molecule | 10 mg | — |
| Subject | Empagliflozin | Small molecule | 10 mg | — |
| Subject | Exenatide | Peptide | 15 ug | — |
| Subject | Liraglutide | Peptide | 0.6 mg | — |
| Subject | Metformin | Small molecule | 500 mg | — |
| Subject | Pioglitazone | Small molecule | 30 mg | — |
| Subject | insulin degludec | Protein / enzyme biologic | 5 unknown | — |
| Subject | insulin degludec | Protein / enzyme biologic | 15 unknown | — |
| Subject | insulin glargine | Protein / enzyme biologic | 6 unknown | — |
| Subject | insulin glargine | Protein / enzyme biologic | 20 unknown | — |