Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study
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ClinicalTrials.gov Identifier: NCT02201602 |
Recruitment Status :
Completed
First Posted : July 28, 2014
Last Update Posted : September 1, 2016
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Condition or disease | Intervention/treatment | Phase |
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Diabetes | Drug: Gliclazide Drug: Glibenclamide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
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Experimental: Gliclazide
Gliclazide, 80 mg tablet, half to maximal dose, 3 weeks
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Drug: Gliclazide
Other Names:
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Active Comparator: Glibenclamide
Glibenclamide, 5 mg tablet, half to maximal dose, 3 weeks
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Drug: Glibenclamide
Other Names:
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- Mean blood glucose level [ Time Frame: 6 days ]
- Glycemic variability [ Time Frame: 6 days ]Glycemic variability will be assessed using the EasyGV software (http://www.phc.ox.ac.uk/research/diabetes/software/easygv/) which is capable of calculating 10 different measures of glycemic variability from continuous glucose monitoring data, such as Standard Deviation (SD) and M-value, mean amplitude of glycemic excursions (MAGE).

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Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201602
Singapore | |
Khoo Teck Puat Hospital | |
Singapore, Singapore, 768828 |
Principal Investigator: | Su Chi Lim, MBBS, PhD | Khoo Teck Puat Hospital |
Responsible Party: | Su Chi Lim, Senior Consultant, Khoo Teck Puat Hospital |
ClinicalTrials.gov Identifier: | NCT02201602 |
Other Study ID Numbers: |
Gliclazide |
First Posted: | July 28, 2014 Key Record Dates |
Last Update Posted: | September 1, 2016 |
Last Verified: | August 2016 |
sulphonylureas gliclazide glibenclamide |
Gliclazide Glyburide Hypoglycemic Agents Physiological Effects of Drugs |