Variation in Sulphonylurea Response in Type 2 Diabetes

Phase 4TerminatedNCT00738088

NHS Tayside14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

HbA1c reduction

Time frame: 6 weeks

Secondary Outcomes

insulin secretory response to glucose and tolbutamide

Time frame: acute