Variation in Sulphonylurea Response in Type 2 Diabetes - Full Text View

Sponsored by:	NHS Tayside
Information provided by:	NHS Tayside
ClinicalTrials.gov Identifier:	NCT00738088

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Gliclazide

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
1: Experimental 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

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

Keywords provided by NHS Tayside:

Sulphonylurea
Pharmacogenetics

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Gliclazide
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Gliclazide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009