Oral insulin for prevention of diabetes in relatives at risk for type 1 diabetes mellitus - ND

Phase 1

• Conditions: prevention of type 1 diabetes mellitus in subjects at risk for T1DM; MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2006-006550-96-IT
• Lead Sponsor: IDDK TYPE 1 DIABETES TRIALNET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-23
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. have a proband with T1Dm 2. if the proband is a first degree relative the partecipant must be 3-45 years of age. If the proband is a second or third degree relative the partecipant must be 3-20 years of age. 3. OGTT performed within 7 weeks prior to randomization with: fasting plasma glucose <110 mg/dl 2 hour plasma glucose <140 mg/dl 4. mIAA confirmed positive within the previous six months. 5. two samples with at least one autoantibody other than mIAA positive within the previous six months. 6. willing to sign Informed Consent Form.
Are the trial subjects under 18? yes
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. does not satisfy the above inclusion criteria. 2. has severe active disease. 3. prior partecipation in a trial for prevention of T1DM. 4. ongoing use of medications known to influence glucose. 5. Pregnant women or lactating. 6. OGTT that reveals diabetes, Impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) 7. sunject has HLADQA1*0102,HLADQB1*0602.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: determine whether intervention with repeated oral administration of recombinant human insulin will prevent or delay the development of clinical type 1 Diabetes Mellitus (T1DM) in non diabetic relatives of patients with T1DM who are positive for insulin autoantibodies but who do not have a metabolic defect. This intervention wil be compared with placebo given in a double-masked fashion.;Secondary Objective: Description of the effects of treatment with oral insulin versus placebo in other catgories of subjects defined using different combinations of autoantibodies and metabolic status (The Secondary Analysis Strata)and an assesment of the consistency of treatment effect among strata. Assesment of the effects of treatment on immunologic and metabolic markers.;Primary end point(s): elapsed time from random treatment assignment to the development of diabetes among those enrolled in the primary analysis cohort consisting of subjects with insulin autoimmunity and absence of metabolic abnormality.