The effect of insulin therapy on beta-cell survival in patients with Maturity Onset Diabetes of the Young ( MODY) 3. A 2 year, single-centre, open-label, randomised, parallel-group trial comparing insulin therapy to conventional oral sulphonyurea on beta-cell survival.

Conditions: The effect of insulin therapy on beta-cell survival in patients with Maturity Onset Diabetes of the Young ( MODY ) 3.
MedDRA version: 9.1Level: PTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent

Registration Number: EUCTR2008-005263-34-IE

Lead Sponsor: The Mater Foundation/HRB Grant

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Subjects with Maturity Onset Diabetes Of The Young (MODY) type 3.
2.Informed consent obtained before any trial-related activities. Trial-related activities are any procedues that would not have been performed during normal management of the subject.
3.Able and willing to use insulin injections for the entire trial period.
4.Males and females >/= 18 years of age or 5.BMI6.Able and willing to perform self-monitoring.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects taking beta blockers or thaizide diuretics.
2. Subjects with systemic illnesses including renal, heart, liver or malignant disease.
3. Pregnant women will be excluded.
4. Pregnant or planning to become pregnant within the next 3 years, breast-feeding, or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device ( IUD) , oral contraceptive or consistent use of barrier methods.
5. Inadequate capability to communicate or to cooperate.
6. Legal Incompetence
7. Alcohol/drug abuse
8. Known or suspected allergy to trial products or related products.
9. Any condition that the Investigator and/ or the Sponsor feel would interfere with trial participation or the evaluation of results.
10. Mental incapacity , unwillingness or language barrier precluding adequate understanding or co-operation.
11.Receipt of any investigational trial drug within 3 months prior to participation in this trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The pathways that control insulin secretion and regulate pancreatic beta-cell mass are crucial in the development and progression of diabetes mellitus. The objective of this study is to evaluate beta-cell function at baseline in subjects with MODY3 and to determine if insulin therapy will delay beta-cell failure in comparison to MODY3 subjects treated with the sulphonylurea gliclazide. As beta-cell mass cannot be evaluated in humans due to the unavailability of pancreatic biopsies we will use the pattern of insulin secretion as an indirect marker of beta-cell mass. ;Secondary Objective: HBA1C<br>Lipid Profile<br>Weight Change <br>Blood Pressure <br>;Primary end point(s): The primary end point is to asses beta-cell survival in MODY 3 patients treated with insulin vs oral sulphonylurea Gliclizide by measuring insulin secretion rates in response to oral and iv glucose.

Secondary Outcome Measures