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Completed

NCT Number: NCT02898506

Incretin-based Therapy in Late Preclinical Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Oulu and Oulu University Hospital, Dept of Children and Adolescents, Oulu, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Victoza®

Drug

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

Drug

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.

Primary outcomes

  1. FPIR (1+3min serum insulin level after iv glucose infusion)

    Time frame: 12 months

    First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)

Secondary outcomes

  1. Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia

    Time frame: 12 months

    Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia

  2. Tolerability

    Time frame: 12 months

    Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular

  3. Serum C-peptide AUC

    Time frame: 12 months

    Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital
  • Skane University Hospital
  • Tampere University Hospital
  • Turku University Hospital

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2016
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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