NCT02611232

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

8.5 years

First QC Date

November 18, 2015

Last Update Submit

January 7, 2022

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • FPIR (first phase insulin response)

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

    From baseline to 26 and 104 weeks

Secondary Outcomes (3)

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

    From baseline to 26 and 104 weeks

  • Tolerability

    From baseline to 26 and 104 weeks

  • Serum C-peptide AUC

    From baseline to 26 and 104 weeks

Study Arms (2)

Victoza®

ACTIVE COMPARATOR

Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)

Drug: Victoza®

Placebo

PLACEBO COMPARATOR

Subjects with preclinical type 1 diabetes aged 18-30 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. Duration of follow-up 24 months.

Victoza®
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • positive for at least 2 biochemical islet autoantibodies
  • have normal glucose tolerance in OGTT
  • are 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 ≥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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Oulu and Oulu University Hospital

Oulu, 90029, Finland

Location

University of Tampere and Tampere University Hospital

Tampere, 33521, Finland

Location

University of Turku and Turku University Hospital

Turku, 20520, Finland

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

November 18, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

FI(3)