Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

NCT02908087 | Completed Phase 2 DMC

• 4 other identifiers: LiraT1D10-302014-004760-373-SRA-2014-301-M-RU1111-1177-0661
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 4

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.

Conditions

Type 1 Diabetes

Keywords

Diabetes Type 1; Diabetes, Insulin-Dependent; Liraglutide; GLP-1 Analogue; Early diagnosis

Outcome Measures

Primary Outcomes (1)

• Serum C-peptide AUC

  Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)

  From baseline to 26 and 52 weeks

Secondary Outcomes (4)

• Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored

  From baseline to 26 and 52 weeks

• Number of hypoglycemia episodes

  From baseline to 26 and 52 weeks

• Frequency of gastrointestinal side effects

  12 months

• Insulin dose

  From baseline to 26 and 52 weeks

Study Arms (2)

Victoza® (liraglutide)

ACTIVE COMPARATOR

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®

Drug: Victoza® (liraglutide)

Placebo

PLACEBO COMPARATOR

Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo

Drug: Placebo

Interventions

Victoza® (liraglutide) DRUG

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

Victoza® (liraglutide)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
• not pregnant.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator
• Turku University Hospital: collaborator
• Skane University Hospital: collaborator

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: 35797241 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Disease

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 20, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

FI (3); SE (1)