Variation in Sulphonylurea Response in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00738088
• Other study ID #: 2007DM02
• Secondary ID: EudraCT 2007-000
• Status: Terminated
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: March 3, 2011

Study information

• Verified date: May 2018
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 3, 2011
• Est. primary completion date: March 3, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• gliclazide
Gliclazide 80mg bd for 6 weeks

Locations

Country	Name	City	State
United Kingdom	NHS Tayside	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c reduction		6 weeks
Secondary	insulin secretory response to glucose and tolbutamide		acute