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Variation in Sulphonylurea Response in Type 2 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by NHS Tayside.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738088
First Posted: August 20, 2008
Last Update Posted: August 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NHS Tayside
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology

Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • HbA1c reduction [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • insulin secretory response to glucose and tolbutamide [ Time Frame: acute ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ewan Pearson, Ninewells Hospital & Medical School
ClinicalTrials.gov Identifier: NCT00738088     History of Changes
Other Study ID Numbers: 2007DM02
EudraCT 2007-000594-29
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: August 20, 2008
Last Verified: August 2008

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