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Variation in Sulphonylurea Response in Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
gliclazide
Sponsored by
NHS Tayside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Sulphonylurea, Pharmacogenetics

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHS Tayside

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

HbA1c reduction

Secondary Outcome Measures

insulin secretory response to glucose and tolbutamide

Full Information

First Posted
August 18, 2008
Last Updated
May 1, 2018
Sponsor
NHS Tayside
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1. Study Identification

Unique Protocol Identification Number
NCT00738088
Brief Title
Variation in Sulphonylurea Response in Type 2 Diabetes
Official Title
The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Following Regulator inspection in 2009, study terminated as inadequate approvals were in place
Study Start Date
June 2007 (Actual)
Primary Completion Date
March 3, 2011 (Actual)
Study Completion Date
March 3, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Tayside

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Sulphonylurea, Pharmacogenetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c
Intervention Type
Drug
Intervention Name(s)
gliclazide
Other Intervention Name(s)
Diamicron
Intervention Description
Gliclazide 80mg bd for 6 weeks
Primary Outcome Measure Information:
Title
HbA1c reduction
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
insulin secretory response to glucose and tolbutamide
Time Frame
acute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewan R Pearson
Organizational Affiliation
NHS Tayside
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Tayside
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

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Variation in Sulphonylurea Response in Type 2 Diabetes

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