Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-05-31

Brief Summary

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The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.

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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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Victoza® (liraglutide)

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®

Group Type ACTIVE_COMPARATOR

Victoza® (liraglutide)

Intervention Type DRUG

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Placebo

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Interventions

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Victoza® (liraglutide)

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Intervention Type DRUG

Placebo

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 10-30 years of age
* early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
* not pregnant.

Exclusion Criteria

* allergic to liraglutide or other ingredients of Victoza®
* diabetic ketoacidosis
* previous treatment in the last three months with any antidiabetic medication other than insulin
* impaired liver or kidney function or on dialysis
* severe heart failure
* severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
* past or current history of pancreatitis
* serum calcitonin value above normal (\>50 ng/l or ≥3.4pmol/l)
* presence of any chronic metabolic, hematologic or malignant disease
* obesity BMI ≥30
* pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
* breast-feeding

Minimum Eligible Age

10 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No