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

NCT ID: NCT02617654

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-09-30

Brief Summary

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Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations \>0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells.

The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Liraglutide treatment

Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Treatment with liraglutide for 52 weeks

Placebo treatment

Treatment with placebo once daily for 52 weeks

Group Type PLACEBO_COMPARATOR

Placebo for liraglutide

Intervention Type DRUG

Placebo for liraglutide. Treatment once daily for 52 weeks

Interventions

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Liraglutide

Treatment with liraglutide for 52 weeks

Intervention Type DRUG

Placebo for liraglutide

Placebo for liraglutide. Treatment once daily for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Per-Ola Carlsson

OTHER

Sponsor Role lead

Responsible Party

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Per-Ola Carlsson

Professor, senior consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per-Ola Carlsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

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Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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U1111-1166-6923

Identifier Type: -

Identifier Source: org_study_id