Variation in Sulphonylurea Response in Type 2 Diabetes

May 1, 2018 updated by: Ewan Pearson, NHS Tayside

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c
Drug: gliclazide
Gliclazide 80mg bd for 6 weeks
Other Names:
  • Diamicron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c reduction
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
insulin secretory response to glucose and tolbutamide
Time Frame: acute
acute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Tayside

Investigators

  • Principal Investigator: Ewan R Pearson, NHS Tayside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2007

Primary Completion (Actual)

March 3, 2011

Study Completion (Actual)

March 3, 2011

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007DM02
  • EudraCT 2007-000594-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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