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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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: gliclazide
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • HbA1c reduction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin secretory response to glucose and tolbutamide [ Time Frame: acute ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Diamicron

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738088

Locations
United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
NHS Tayside
Investigators
Principal Investigator: Ewan R Pearson NHS Tayside
  More Information

No publications provided

Responsible Party: Ewan Pearson, Ninewells Hospital & Medical School
ClinicalTrials.gov Identifier: NCT00738088     History of Changes
Other Study ID Numbers: 2007DM02, EudraCT 2007-000594-29
Study First Received: August 18, 2008
Last Updated: August 18, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Tayside:
Sulphonylurea
Pharmacogenetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013