Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Phase 2

Completed

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

• Registration Number: NCT02908087
• Lead Sponsor: University of Oulu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Victoza® (liraglutide)	Victoza® (liraglutide)	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®
Placebo	Placebo	Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo

Primary Outcome Measures

Name	Time	Method
Serum C-peptide AUC	From baseline to 26 and 52 weeks	Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)

Secondary Outcome Measures

Name	Time	Method
Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored	From baseline to 26 and 52 weeks	Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period
Number of hypoglycemia episodes	From baseline to 26 and 52 weeks	Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period
Frequency of gastrointestinal side effects	12 months	Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period
Insulin dose	From baseline to 26 and 52 weeks	Insulin dose IU/kg/day

Trial Locations

Locations (4)

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

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

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

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