Variation in Sulphonylurea Response in Type 2 Diabetes

NCT ID: NCT00738088

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-03-03

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c

Group Type: EXPERIMENTAL

gliclazide

Intervention Type: DRUG

Gliclazide 80mg bd for 6 weeks

Interventions

gliclazide

Gliclazide 80mg bd for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Diamicron

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Tayside

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ewan Pearson

Professor of Diabetic Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ewan R Pearson

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Locations

NHS Tayside

Dundee, , United Kingdom

Countries

United Kingdom

Other Identifiers

EudraCT 2007-000594-29

Identifier Type: -

Identifier Source: secondary_id

2007DM02

Identifier Type: -

Identifier Source: org_study_id