Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908087
• Other study ID #: LiraT1D10-30
• Secondary ID: 2014-004760-373-
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: May 2021

Study information

• Verified date: January 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Victoza® (liraglutide)
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
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Locations

Country	Name	City	State
Finland	University of Oulu and Oulu University Hospital, Dept of Children and Adolescents	Oulu
Finland	University of Tampere and Tampere University Hospital	Tampere
Finland	University of Turku and Turku University Hospital	Turku
Sweden	Lund University and Skåne University Hospital	Malmö

Sponsors (5)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital, Skane University Hospital, Tampere University Hospital, Turku University Hospital

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

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