Clinical trial NCT02898506: Incretin-based Therapy in Late Preclinical Type 1 Diabetes
Official title: Incretin-based Therapy in Late Preclinical Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Diabetes Type 1
Diabetes, Insulin-Dependent
Liraglutide
Preclinical Type 1 Diabetes
GLP-1 Analogue
Dysglycemia
Prevention
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Tampere University Hospital
name: Turku University Hospital
name: Skane University Hospital
First posted: 2016-09-13
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 10-30 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

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 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

Primary outcomes:
measure: FPIR (1+3min serum insulin level after iv glucose infusion)
timeFrame: 12 months
Secondary outcomes:
measure: Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
timeFrame: 12 months
measure: Tolerability
timeFrame: 12 months
measure: Serum C-peptide AUC
timeFrame: 12 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
city: Tampere
country: Finland
facility: University of Tampere and Tampere University Hospital
city: Turku
country: Finland
facility: University of Turku and Turku University Hospital
city: Malmö
country: Sweden
facility: Lund University and Skåne University Hospital
Study officials:
affiliation: University of Oulu
name: Riitta Veijola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.