Variation in Sulphonylurea Response in Type 2 Diabetes

Phase 4

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: gliclazide

• Registration Number: NCT00738088
• Lead Sponsor: NHS Tayside

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-20
• Primary Completion: 2011-03-03
• Study Completion: 2011-03-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	gliclazide	Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c

Primary Outcome Measures

Name	Time	Method
HbA1c reduction	6 weeks

Secondary Outcome Measures

Name	Time	Method
insulin secretory response to glucose and tolbutamide	acute

Trial Locations

Locations (1)

NHS Tayside; 🇬🇧 Dundee, United Kingdom