Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes

Launched by PER-OLA CARLSSON · Nov 25, 2015

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent for participation of the study, given before undergoing any study-specific procedures.
• • 2. 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
• • 3. Clinical diagnose of T1D
• • 4. Five or more years duration of disease
• • 5. HbA1C between 45 and 75 mmol/mol
• • 6. Fasting plasma C-peptide concentration \>1.5 pmol/l.
• Exclusion Criteria:
• • 1. Inability to provide informed consent
• • 2. Mental incapacity
• • 3. Unwillingness or language barrier precluding adequate understanding or cooperation
• • 4. Ongoing or planned pregnancy within the next 12 months
• • 5. Inadequate or no use of contraceptives
• • 6. Ongoing breast feeding
• • 7. Known sight-threatening retinopathy
• • 8. Creatinine clearance \<60 ml/min
• • 9. Life-threatening cardiovascular disease
• • 10. History of drug/alcohol abuse
• • 11. Known or suspected allergy to trial product or related product
• • 12. Recurrent assisted hypoglycemias
• • 13. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
• • 14. Uncontrolled hypertension (180/105 mmHg or above)
• • 15. History of acute or chronic pancreatitis
• • 16. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
• • 17. Personal history of non-familial medullary thyroid carcinoma.
• • 18. Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results