Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

Phase 2

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

• Registration Number: NCT02611232
• Lead Sponsor: University of Oulu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2015-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-25
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Victoza®	Victoza®	Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)
Placebo	Placebo	Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo

Primary Outcome Measures

Name	Time	Method
FPIR (first phase insulin response)	From baseline to 26 and 104 weeks	First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )

Secondary Outcome Measures

Name	Time	Method
Serum C-peptide AUC	From baseline to 26 and 104 weeks	Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia	From baseline to 26 and 104 weeks	Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Tolerability	From baseline to 26 and 104 weeks	Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms

Trial Locations

Locations (3)

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

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

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