Incretin-based therapy in non-symptomatic, early diagnosed type 1 diabetics

Incretin-based therapy in non-symptomatic, early diagnosed type 1 diabetics - LiraT1D10-30

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004760-37-FI

Enrollment

Registered

2015-12-21

Start date

2015-12-23

Completion date

Unknown

Last updated

2015-12-28

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: Victoxa Product Code: A10BX07 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Pharmaceutical fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects are 10-30 years of age, have early diagnosis type 1 diabetes (no symptoms, diagnosis usually in OGTT), and are not pregnant. Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 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: • previous treatment in the last three months with any antidiabetic medication other than insulin • 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 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 usually in OGTT), and treated with insulin.;Secondary Objective: In addition, the effect of daily liraglutide treatment on immunological variables and blood glucose control will be studied. ;Primary end point(s): Primary end point (1) is: 1) serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed meal tolerance test);Timepoint(s) of evaluation of this end point: Timepoints for evaluation of primary end point (1) are: 1) 1 week before start of treatment and 3, 6, 9 and 12 months 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 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 usually in OGTT), and treated with insulin.;Secondary Objective: In addition, the effect of daily liraglutide treatment on immunological variables and blood glucose control will be studied. ;Primary end point(s): Primary end point (1) is: 1) serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed meal tolerance test);Timepoint(s) of evaluation of this end point: Timepoints for evaluation of primary end point (1) are: 1) 1 week before start of treatment and 3, 6, 9 and 12 months after start of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points (1-5) are: 1) insulin dose IU/kg/day 2) plasma glucose variability during continuous glucose monitoring (CGM) 3) HbA1c 4) safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia 5) tolerability: frequency of gastrointestinal side effects (diarrhea, nausea, vomiting);Timepoint(s) of evaluation of this end point: Timepoints for evaluation of secondary end points (1-5) are: 1) 1 wk before start of treatment, at the start of treatment, and then at 1, 2, 3, 4, 5, 6 wk and 3, 4, 5, 6 mo, 6 mo + 1 wk, 7, 8, 9, 10, 11, 12 mo and 12 mo + 1 wk after start of treatment 2) 1 wk before start of treatment, and 3, 6, 9 and 12 mo after start of treatment 3) 1 wk before start of treatment, and 6 wk, 3, 6, 9 and 12 mo after start of treatment 4) 1 wk before start of treatment, and 6 wk, 3 , 6 , 9 and 12 mo after start of treatment 5) 1, 2, 3, 4, 5, 6 wk and 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 mo after start of treatment	—

Measure

Time frame

Secondary end point(s): Secondary end points (1-5) are: 1) insulin dose IU/kg/day 2) plasma glucose variability during continuous glucose monitoring (CGM) 3) HbA1c 4) safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia 5) tolerability: frequency of gastrointestinal side effects (diarrhea, nausea, vomiting);Timepoint(s) of evaluation of this end point: Timepoints for evaluation of secondary end points (1-5) are: 1) 1 wk before start of treatment, at the start of treatment, and then at 1, 2, 3, 4, 5, 6 wk and 3, 4, 5, 6 mo, 6 mo + 1 wk, 7, 8, 9, 10, 11, 12 mo and 12 mo + 1 wk after start of treatment 2) 1 wk before start of treatment, and 3, 6, 9 and 12 mo after start of treatment 3) 1 wk before start of treatment, and 6 wk, 3, 6, 9 and 12 mo after start of treatment 4) 1 wk before start of treatment, and 6 wk, 3 , 6 , 9 and 12 mo after start of treatment 5) 1, 2, 3, 4, 5, 6 wk and 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 mo after start of treatment

—

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