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TerminatedNCT00738088Updated May 3, 2018

Variation in Sulphonylurea Response in Type 2 Diabetes

A Phase 4 interventional study of gliclazide in Diabetes Mellitus, Type 2, sponsored by NHS Tayside. Terminated at 1 site in United Kingdom. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by NHS Tayside · Phase 4, Interventional, and Treatment

Why this study was terminated
Following Regulator inspection in 2009, study terminated as inadequate approvals were in place

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2007, registered Aug 2008).
Phase
Phase 4
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
35 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Sulphonylurea
  • Pharmacogenetics
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

NHS Tayside is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    1

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

    Drug: gliclazide

Interventions

  • Druggliclazide

    Gliclazide 80mg bd for 6 weeks

    Also known as: Diamicron

06

What researchers measure

Primary outcomes

  1. HbA1c reduction

    Time frame: 6 weeks

Secondary outcomes

  1. insulin secretory response to glucose and tolbutamide

    Time frame: acute

07

Study locations

1 site
  • NHS Tayside
    Dundee, DD1 9SY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00738088
Lead sponsor
NHS Tayside
Responsible party
Ewan Pearson (Professor of Diabetic Medicine, NHS Tayside) — Principal investigator
First posted
Aug 20, 2008
Start date
Jun 2007
Primary completion
Mar 3, 2011
Completion
Mar 3, 2011
Last update
May 3, 2018

Study contacts

Ewan R Pearson
principal investigator · NHS Tayside

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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