Incretin-based therapy in preclinical type 1 diabetes in adults.
- Conditions
- Type 1 diabetesMedDRA version: 18.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2014-003667-37-FI
- Lead Sponsor
- Riitta Veijola
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
The subjects are 18-30 years of age, positive for at least 2 islet autoantibodies, have normal glucose tolerance in OGTT and are not pregnant.
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 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Principal exclusion criteria are:
• type 1 diabetes
• previous treatment in the last three months with any antidiabetic medication
• impaired liver or kidney function
• past or current history of pancreatitis
• serum calcitonin value above normal (>50 ng/l)
• presence of any chronic metabolic, hematologic or malignant disease
• obesity BMI =30
• pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method