Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

January 7, 2022 updated by: Riitta Veijola, University of Oulu
The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90029
        • University of Oulu and Oulu University Hospital
      • Tampere, Finland, 33521
        • University of Tampere and Tampere University Hospital
      • Turku, Finland, 20520
        • University of Turku and Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-30 years of age
  • positive for at least 2 biochemical islet autoantibodies
  • have normal glucose tolerance in OGTT
  • are not pregnant

Exclusion Criteria:

  • allergic to liraglutide or other ingredients of Victoza®
  • Type 1 diabetes
  • diabetic ketoacidosis
  • previous treatment in the last three months with any antidiabetic medication
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Victoza®
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)
Drug: Victoza®
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.
Placebo Comparator: Placebo
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo
Drug: Placebo
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FPIR (first phase insulin response)
Time Frame: From baseline to 26 and 104 weeks
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )
From baseline to 26 and 104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Time Frame: From baseline to 26 and 104 weeks
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
From baseline to 26 and 104 weeks
Tolerability
Time Frame: From baseline to 26 and 104 weeks
Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms
From baseline to 26 and 104 weeks
Serum C-peptide AUC
Time Frame: From baseline to 26 and 104 weeks
Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)
From baseline to 26 and 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Turku University Hospital
Oulu University Hospital
Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiraAAB18-30
  • 3-SRA-2014-301-M-R (Other Grant/Funding Number: Juvenile Diabetes Research Foundation International)
  • 2014-003667-37 (EudraCT Number)
  • U1111-1176-6062 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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