drugset / Trial / NCT01758380
Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
Timeline
- Start
- 2013-01
- Primary completion
- 2013-09
- Completion
- 2013-09
Outcome
Met primary endpoint
paper confirmed (<3.9 mmol/L and/or severe) hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test) PMID 24920915 ↗
Publications
- Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
- Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gliclazide | Small molecule | 80 mg | — |
| Subject | Gliclazide | Small molecule | 320 mg | — |
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |
| Background | Metformin | Small molecule | 1500 mg | — |
| Background | Metformin | Small molecule | 2500 mg | — |