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 个研究点开始时间: 2008年11月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

The Mater Foundation/HRB Grant