EUCTR2008-005263-34-IE
Active, not recruiting
Not Applicable
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.
The Mater Foundation/HRB Grant0 sitesNovember 7, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The effect of insulin therapy on beta-cell survival in patients with Maturity Onset Diabetes of the Young ( MODY ) 3.
- Sponsor
- The Mater Foundation/HRB Grant
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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