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Status unknownNCT02611232Updated Jan 25, 2022

Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

A Phase 2 interventional study of Victoza® and Placebo in Type 1 Diabetes, sponsored by University of Oulu. Status unknown at 3 sites in Finland. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by University of Oulu · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Diabetes Type 1
  • Diabetes, Insulin-Dependent
  • Liraglutide
  • Preclinical Type 1 Diabetes
  • GLP-1 Analogue
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 42 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    Victoza®

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

    Drug: Victoza®

  • Placebo comparator
    Placebo

    Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo

    Drug: Placebo

Interventions

  • DrugVictoza®

    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

  • DrugPlacebo

    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

06

What researchers measure

Primary outcomes

  1. FPIR (first phase insulin response)

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

    Time frame: From baseline to 26 and 104 weeks

Secondary outcomes

  1. Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia

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

    Time frame: From baseline to 26 and 104 weeks

  2. Tolerability

    Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms

    Time frame: From baseline to 26 and 104 weeks

  3. Serum C-peptide AUC

    Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)

    Time frame: From baseline to 26 and 104 weeks

07

Study locations

3 sites
  • University of Oulu and Oulu University Hospital
    Oulu, 90029, Finland
  • University of Tampere and Tampere University Hospital
    Tampere, 33521, Finland
  • University of Turku and Turku University Hospital
    Turku, 20520, Finland
08

References and documents

Publications

  • 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. PubMed 35797241 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02611232
Lead sponsor
University of Oulu
Collaborators
Oulu University Hospital, Tampere University Hospital, Turku University Hospital
Responsible party
Riitta Veijola (Professor, University of Oulu) — Principal investigator
First posted
Nov 20, 2015
Start date
Dec 2015
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Jan 25, 2022

Study contacts

Riitta Veijola, MD
principal investigator · University of Oulu

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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