We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Variation in Sulphonylurea Response in Type 2 Diabetes

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.
ClinicalTrials.gov Identifier: NCT00738088
Recruitment Status : Unknown
Verified August 2008 by NHS Tayside.
Recruitment status was:  Enrolling by invitation
First Posted : August 20, 2008
Last Update Posted : August 20, 2008
Information provided by:
NHS Tayside

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: gliclazide Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Study Start Date : June 2007
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Diamicron

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

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

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

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 Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 20, 2008
Last Verified: August 2008

Keywords provided by NHS Tayside:

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