Variation in Sulphonylurea Response in Type 2 Diabetes

NCT00738088 | Terminated Phase 4

• 2 other identifiers: 2007DM02EudraCT 2007-000594-29
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Sulphonylurea; Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• HbA1c reduction

  6 weeks

Secondary Outcomes (1)

• insulin secretory response to glucose and tolbutamide

  acute

Study Arms (1)

1

EXPERIMENTAL

Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c

Drug: gliclazide

Interventions

gliclazide DRUG

Gliclazide 80mg bd for 6 weeks

Also known as: Diamicron

1

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Tayside: lead

Study Sites (1)

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gliclazide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Ewan R Pearson

  NHS Tayside

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Diabetic Medicine

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: June 1, 2007
• Primary Completion: March 3, 2011
• Study Completion: March 3, 2011
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

GB (1)