Incretin-based Therapy in Late Preclinical Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Incretin-based Therapy in Late Preclinical Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898506
• Other study ID #: LiraAABDG10-30
• Secondary ID: 2014-004761-25U1
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: June 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 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.

Recruitment information / eligibility

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

Eligibility

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

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 and thereafter follow-up of 6 months.
• Placebo
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 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	FPIR (1+3min serum insulin level after iv glucose infusion)	First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)	12 months
Secondary	Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia	Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia	12 months
Secondary	Tolerability	Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular	12 months
Secondary	Serum C-peptide AUC	Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)	12 months