Incretin-based therapy in preclinical type 1 diabetes in adults.

Incretin-based therapy in preclinical type 1 diabetes in adults. - LiraAAB18-30

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003667-37-FI

Enrollment

Registered

2015-11-05

Start date

2015-11-19

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes MedDRA version: 18.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Victoza Product Name: Victoza Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Pharmaceutical form of the placebo: Sol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects are 18-30 years of age, positive for at least 2 islet autoantibodies, have normal glucose tolerance in OGTT and are not pregnant. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Principal exclusion criteria are: • type 1 diabetes • previous treatment in the last three months with any antidiabetic medication • impaired liver or kidney function • past or current history of pancreatitis • serum calcitonin value above normal (>50 ng/l) • presence of any chronic metabolic, hematologic or malignant disease • obesity BMI =30 • pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is 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. ;Secondary Objective: In addition, the effect of daily liraglutide treatment on immunological variables will be studied. The rate of progression to dysglycaemia and overt diabetes will also be closely monitored. ;Primary end point(s): Primary end points (1-3) are: 1) serum C-peptide area under the curve (AUC) during 2-hour OGTT 2) first phase insulin response (FPIR = 1 + 3 min serum insulin) during 10-min IVGTT 3) serum insulin AUC during 10-min IVGTT ;Timepoint(s) of evaluation of this end point: Timepoints for evaluation of primary end points (1-3) are: 1) 2 weeks before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 months after start of treatment 2) At the start of treatment and 2 mo, 6 mo + 2 wk, 12 mo + 2 wk and 24 mo + 2 wk after start of treatment 3) At the start of treatment and 2 mo, 6 mo + 2 wk, 12 mo + 2 wk and 24 mo + 2 wk after start of treatment	—

Measure

Time frame

Main Objective: The main objective of the trial is 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. ;Secondary Objective: In addition, the effect of daily liraglutide treatment on immunological variables will be studied. The rate of progression to dysglycaemia and overt diabetes will also be closely monitored. ;Primary end point(s): Primary end points (1-3) are: 1) serum C-peptide area under the curve (AUC) during 2-hour OGTT 2) first phase insulin response (FPIR = 1 + 3 min serum insulin) during 10-min IVGTT 3) serum insulin AUC during 10-min IVGTT ;Timepoint(s) of evaluation of this end point: Timepoints for evaluation of primary end points (1-3) are: 1) 2 weeks before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 months after start of treatment 2) At the start of treatment and 2 mo, 6 mo + 2 wk, 12 mo + 2 wk and 24 mo + 2 wk after start of treatment 3) At the start of treatment and 2 mo, 6 mo + 2 wk, 12 mo + 2 wk and 24 mo + 2 wk after start of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points (1-6) are: 1) safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia 2) tolerability: frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) 3) plasma glucose variability during continuous glucose monitoring (CGM) 4) HbA1c 5) proportion of subjects diagnosed with dysglycemia or type 1 diabetes 6) time to the development of dysglycemia or type 1 diabetes from the start of the trial drug ;Timepoint(s) of evaluation of this end point: Timepoints for evaluation of secondary end points (1-6) are: 1) 2 weeks before start of treatment, at the start of treatment, 4 wk, 2 months, 4 mo, 6 mo + 2 wk, 9 mo, 12 mo, 18 mo and 24 mo + 2 wk after start of treatment 2) 1, 2, 3, 4 wk and 2, 4, 6, 9, 12, 18, 24 mo after start of treatment 3) 2 wk before start of treatment and 6, 12 and 24 mo after start of treatment 4) 2 wk before start of treatment and 4 wk, and 2, 4, 6, 9, 12, 18 and 24 mo after start of treatment 5) 2 wk before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 mo after start of treatment 6) 2 wk before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 mo after start of treatment	—

Measure

Time frame

Secondary end point(s): Secondary end points (1-6) are: 1) safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia 2) tolerability: frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) 3) plasma glucose variability during continuous glucose monitoring (CGM) 4) HbA1c 5) proportion of subjects diagnosed with dysglycemia or type 1 diabetes 6) time to the development of dysglycemia or type 1 diabetes from the start of the trial drug ;Timepoint(s) of evaluation of this end point: Timepoints for evaluation of secondary end points (1-6) are: 1) 2 weeks before start of treatment, at the start of treatment, 4 wk, 2 months, 4 mo, 6 mo + 2 wk, 9 mo, 12 mo, 18 mo and 24 mo + 2 wk after start of treatment 2) 1, 2, 3, 4 wk and 2, 4, 6, 9, 12, 18, 24 mo after start of treatment 3) 2 wk before start of treatment and 6, 12 and 24 mo after start of treatment 4) 2 wk before start of treatment and 4 wk, and 2, 4, 6, 9, 12, 18 and 24 mo after start of treatment 5) 2 wk before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 mo after start of treatment 6) 2 wk before start of treatment and 4 wk, and 4, 6, 9, 12, 18 and 24 mo after start of treatment

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Countries

Finland

Contacts

Public ContactDept of Children and Adolescents

University of Oulu

riitta.veijola@oulu.fi+35883155129

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026