Variation in Sulphonylurea Response in Type 2 Diabetes

• Sponsor: NHS Tayside (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00738088
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 45
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Mar 3, 2011
• Actual Study Completion Date: Mar 3, 2011

Arms and Interventions

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 Names: Diamicron

Outcome Measures

Primary Outcome Measures

1. HbA1c reduction [6 weeks]

Secondary Outcome Measures

1. insulin secretory response to glucose and tolbutamide [acute]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHS Tayside	Dundee		United Kingdom	DD1 9SY

Sponsors and Collaborators

• NHS Tayside

Investigators

• Principal Investigator: Ewan R Pearson, NHS Tayside

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ewan Pearson, Professor of Diabetic Medicine, NHS Tayside
• ClinicalTrials.gov Identifier: NCT00738088
• Other Study ID Numbers: 2007DM02; EudraCT 2007-000594-29
• First Posted: Aug 20, 2008
• Last Update Posted: May 3, 2018
• Last Verified: May 1, 2018

• Keywords provided by Ewan Pearson, Professor of Diabetic Medicine, NHS Tayside: Sulphonylurea; Pharmacogenetics
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Gliclazide

Study Results

No Results Posted as of May 3, 2018