The effect of insulin therapy on beta-cell survival in patients with Maturity Onset Diabetes of the Young ( MODY ) 3. MedDRA version: 9.1 Level: PT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Trade Name: Diamicron
Product Name: Diamicron
Pharmaceutical Form: Capsule, hard
Trade Name: NovoRapid
Product Name: NovoRapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insu
Sponsors
The Mater Foundation/HRB Grant
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Lipid Profile Weight Change Blood Pressure ;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. | — |
Countries
Ireland
Outcome results
None listed