Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study
1 other identifier
interventional
8
1 country
1
Brief Summary
Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes
Started Aug 2014
Typical duration for phase_4 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 1, 2016
August 1, 2016
1.8 years
July 22, 2014
August 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean blood glucose level
6 days
Secondary Outcomes (1)
Glycemic variability
6 days
Study Arms (2)
Gliclazide
EXPERIMENTALGliclazide, 80 mg tablet, half to maximal dose, 3 weeks
Glibenclamide
ACTIVE COMPARATORGlibenclamide, 5 mg tablet, half to maximal dose, 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Age 21-65
- HbA1c \>8.0% on two consecutive visits
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Khoo Teck Puat Hospital
Singapore, Singapore, 768828, Singapore
Related Publications (2)
Gloyn AL, Weedon MN, Owen KR, Turner MJ, Knight BA, Hitman G, Walker M, Levy JC, Sampson M, Halford S, McCarthy MI, Hattersley AT, Frayling TM. Large-scale association studies of variants in genes encoding the pancreatic beta-cell KATP channel subunits Kir6.2 (KCNJ11) and SUR1 (ABCC8) confirm that the KCNJ11 E23K variant is associated with type 2 diabetes. Diabetes. 2003 Feb;52(2):568-72. doi: 10.2337/diabetes.52.2.568.
PMID: 12540637BACKGROUNDHamming KS, Soliman D, Matemisz LC, Niazi O, Lang Y, Gloyn AL, Light PE. Coexpression of the type 2 diabetes susceptibility gene variants KCNJ11 E23K and ABCC8 S1369A alter the ATP and sulfonylurea sensitivities of the ATP-sensitive K(+) channel. Diabetes. 2009 Oct;58(10):2419-24. doi: 10.2337/db09-0143. Epub 2009 Jul 8.
PMID: 19587354BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Su Chi Lim, MBBS, PhD
Khoo Teck Puat Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 28, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
September 1, 2016
Record last verified: 2016-08