Incretin-based therapy in late preclinical type 1 diabetes

• Conditions: Type 1 diabetes; MedDRA version: 18.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-004761-25-FI
• Lead Sponsor: Riitta Veijola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-23
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

The subjects are 10-30 years of age, positive for at least 2 betacell specific autoantibodies, have dysglycemia in OGTT (e.g. impaired glucose tolerance or impaired fasting glucose) or increasing HbA1c (at least 10% increase between two HbA1c measurements or HbA1c at least 5.9% in two measurements), and are not pregnant.
Are the trial subjects under 18? yes
Number of subjects for this age range: 41
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 or ISO-BMI =30 (Cole et al. 2000)
• pregnancy

Study & Design

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