Study of the possibility to increase remnant insulin production in patients with type 1 diabetes using the glucagon-like peptide 1 mimicking drug liraglutide

Phase 1

• Conditions: Beta-cell function in C-peptide positive type 1 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-005174-11-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Written informed consent for participation of the study, given before undergoing any study-specific procedures.
•18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
•Clinical diagnose of T1D
•5 or more years duration of disease
•HbA1C between 45 and 75 mmol/mol
•Fasting plasma C-peptide concentration >1.5 pmol/l.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Inability to provide informed consent
•Mental incapacity
•Unwillingness or language barrier precluding adequate understanding or cooperation
•Ongoing or planned pregnancy within the next 12 months
•Inadequate or no use of contraceptives
•Ongoing breast feeding
•Known sight-threatening retinopathy
•Creatinine clearance <60 ml/min
•Life-threatening cardiovascular disease
•History of drug/alcohol abuse
•Known or suspected allergy to trial product or related product
•Recurrent assisted hypoglycemias
•Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
•Uncontrolled hypertension (180/105 mmHg or above)
•History of acute or chronic pancreatitis
•Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
•Personal history of non-familial medullary thyroid carcinoma.
•Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results

Study & Design

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