Variation in Sulphonylurea Response in Type 2 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
NHS Tayside
ClinicalTrials.gov Identifier:
NCT00738088
First received: August 18, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

August 18, 2008
August 18, 2008
June 2007
January 2009   (final data collection date for primary outcome measure)
HbA1c reduction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
insulin secretory response to glucose and tolbutamide [ Time Frame: acute ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Variation in Sulphonylurea Response in Type 2 Diabetes
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: gliclazide
Gliclazide 80mg bd for 6 weeks
Other Name: Diamicron
Experimental: 1
Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c
Intervention: Drug: gliclazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
80
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00738088
2007DM02, EudraCT 2007-000594-29
No
Ewan Pearson, Ninewells Hospital & Medical School
NHS Tayside
Not Provided
Principal Investigator: Ewan R Pearson NHS Tayside
NHS Tayside
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP