Incretin-based Therapy in Late Preclinical Type 1 Diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Victoza®; Drug: Placebo

• Registration Number: NCT02898506
• Lead Sponsor: University of Oulu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide	Victoza®	Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®
Placebo	Placebo	Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo

Primary Outcome Measures

Name	Time	Method
FPIR (1+3min serum insulin level after iv glucose infusion)	12 months	First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)

Secondary Outcome Measures

Name	Time	Method
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia	12 months	Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Tolerability	12 months	Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular
Serum C-peptide AUC	12 months	Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)

Trial Locations

Locations (4)

University of Oulu and Oulu University Hospital, Dept of Children and Adolescents; 🇫🇮 Oulu, Finland

University of Turku and Turku University Hospital; 🇫🇮 Turku, Finland

Lund University and Skåne University Hospital; 🇸🇪 Malmö, Sweden

University of Tampere and Tampere University Hospital; 🇫🇮 Tampere, Finland