Variation in Sulphonylurea Response in Type 2 Diabetes

The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00738088

Enrollment

Registered

2008-08-20

Start date

2007-06-30

Completion date

2011-03-03

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Sulphonylurea, Pharmacogenetics

Brief summary

The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. In one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. The second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how well they respond to sulphonylurea medication.

Interventions

DRUGgliclazide

Gliclazide 80mg bd for 6 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Age \>35 and \< 70 * Age of diabetes diagnosis \>35 and \<70 * White European * Pre-SU HbA1c \<=10% * HbA1c (on treatment) \<= 9% * No myocardial infarction or Acute coronary syndrome in previous year * No stroke or transient ischaemic attack in previous year * No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months) * eGFR \> 60mls/min * No Proteinuria \>30mg/dl on multistix 10SG * No active foot ulceration or infection * Liver ALT ≤ twice the upper limit of the reference range * Contactable by telephone

Exclusion criteria

* Type 1 diabetes * HbA1c \>10% prior to commencing SU * HbA1c\>9% on SU treatment * Recent MI or Stroke within last 12 months * Pre-proliferative or proliferative retinopathy * eGFR\<60 ml/min * Proteinuria \>30mg/dl on multistix 10SG * Active foot ulceration or infection * Liver ALT \> twice the upper limit of the reference range * Female planning to conceive within the study period * Any other significant medical reason for exclusion as determined by the investigator

Design outcomes

Primary

Measure	Time frame
HbA1c reduction	6 weeks

Secondary

Measure	Time frame
insulin secretory response to glucose and tolbutamide	acute

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026