NCT02898506

Brief Summary

The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

5.3 years

First QC Date

September 7, 2016

Last Update Submit

January 7, 2022

Conditions

Type 1 Diabetes

Keywords

Diabetes Type 1Diabetes, Insulin-DependentLiraglutidePreclinical Type 1 DiabetesGLP-1 AnalogueDysglycemiaPrevention

Outcome Measures

Primary Outcomes (1)

  • FPIR (1+3min serum insulin level after iv glucose infusion)

    First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)

    12 months

Secondary Outcomes (3)

  • Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia

    12 months

  • Tolerability

    12 months

  • Serum C-peptide AUC

    12 months

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®

Drug: Victoza®

Placebo

PLACEBO COMPARATOR

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo

Drug: Placebo

Interventions

Victoza®DRUG

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

Liraglutide
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • positive for at least 2 islet autoantibodies
  • glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT
  • not pregnant

You may not qualify if:

  • 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 at least 3.4pmol/l)
  • presence of any chronic metabolic, hematologic or malignant disease
  • obesity BMI at least 30
  • pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
  • breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Oulu and Oulu University Hospital, Dept of Children and Adolescents

Oulu, 90029, Finland

Location

University of Tampere and Tampere University Hospital

Tampere, 33520, Finland

Location

University of Turku and Turku University Hospital

Turku, 20520, Finland

Location

Lund University and Skåne University Hospital

Malmo, 205 02, Sweden

Location

Related Publications (1)

  • Kero J, Koskenniemi JJ, Karsikas S, Pokka T, Lou O, Toppari J, Veijola R. INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Diabet Med. 2022 Oct;39(10):e14913. doi: 10.1111/dme.14913. Epub 2022 Jul 22.

    PMID: 35797241DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Riitta Veijola, MD

    University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 13, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

SE(1)FI(3)