Clinical trial NCT02908087: Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
Official title: Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Diabetes Type 1
Diabetes, Insulin-Dependent
Liraglutide
GLP-1 Analogue
Early diagnosis
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: 2016-09-20
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: TREATMENT

Brief summary: The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.


Eligibility criteria: Inclusion Criteria:

* 10-30 years of age
* early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
* not pregnant.

Exclusion Criteria:

* allergic to liraglutide or other ingredients of Victoza®
* diabetic ketoacidosis
* previous treatment in the last three months with any antidiabetic medication other than insulin
* 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

Primary outcomes:
measure: Serum C-peptide AUC
timeFrame: From baseline to 26 and 52 weeks
Secondary outcomes:
measure: Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored
timeFrame: From baseline to 26 and 52 weeks
measure: Number of hypoglycemia episodes
timeFrame: From baseline to 26 and 52 weeks
measure: Frequency of gastrointestinal side effects
timeFrame: 12 months
measure: Insulin dose
timeFrame: From baseline to 26 and 52 weeks
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.