drugset / Trial / NCT01238978
Phase 4 Study in the Elderly Patients With T2DM
RandomizedParallel-groupOpen-labelTreatment
Summary
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin
Timeline
- Start
- 2010-10
- Primary completion
- 2011-12
- Completion
- 2011-12
Outcome
Met primary endpoint
paper The incidence of hypoglycaemia/severe hypoglycaemia was significantly higher over 6months in the COAD cohort (20.1%/2.4% vs. 6.4%/0.1%; P<0.001) PMID 22996038 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vildagliptin | Other / unclassified | — | — |