Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2016
• Main ID: NCT02201602
• Date of registration: 22/07/2014
• Prospective Registration: Yes
• Primary sponsor: Khoo Teck Puat Hospital
• Public title: Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study
• Scientific title: Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study
• Date of first enrolment: August 2014
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02201602
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Singapore

Contacts

• Name: Su Chi Lim, MBBS, PhD
• Affiliation: Khoo Teck Puat Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 2 diabetes

- Age 21-65

- HbA1c >8.0% on two consecutive visits

Exclusion Criteria:

- Currently taking insulin at a regime more complex than basal insulin

- Not willing to perform self-blood glucose monitoring (SBGM)

- Renal impairment i.e. eGFR<50mls/min

- Pregnancy or unwilling to practice adequate contraception

- Taking other medications that may affect blood glucose e.g. systemic glucocorticoids.



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Drug: Glibenclamide

Drug: Gliclazide

Primary Outcome(s)

Mean blood glucose level [Time Frame: 6 days]

Secondary Outcome(s)

Glycemic variability [Time Frame: 6 days]

Secondary ID(s)

Gliclazide

Source(s) of Monetary Support

Please refer to primary and secondary sponsors