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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006550-96-IT

Enrollment

300

Registered

2008-04-23

Start date

2007-03-23

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prevention of type 1 diabetes mellitus in subjects at risk for T1DM MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus

Interventions

Trade Name: HUMULIN R Pharmaceutical Form: Capsule, hard INN or Proposed INN: Insulin (human) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Pharmaceutical fo

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Finland, Germany, Italy, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026