Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

Type 1 Diabetes Clinical Trial

Official title:

Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02611232
• Other study ID #: LiraAAB18-30
• Secondary ID: 2014-003667-373-
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: June 2024

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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Victoza®
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.
• Placebo
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

Locations

Country	Name	City	State
Finland	University of Oulu and Oulu University Hospital	Oulu
Finland	University of Tampere and Tampere University Hospital	Tampere
Finland	University of Turku and Turku University Hospital	Turku

Sponsors (4)

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

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FPIR (first phase insulin response)	First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )	From baseline to 26 and 104 weeks
Secondary	Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia	Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia	From baseline to 26 and 104 weeks
Secondary	Tolerability	Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms	From baseline to 26 and 104 weeks
Secondary	Serum C-peptide AUC	Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)	From baseline to 26 and 104 weeks