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Completed

NCT Number: NCT02908087

Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

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 in OGTT), and treated with insulin.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Disease Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

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
  • early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
  • not pregnant.

Exclusion criteria

  • allergic to liraglutide or other ingredients of Victoza®
  • diabetic ketoacidosis
  • previous treatment in the last three months with any antidiabetic medication other than insulin
  • 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

Treatment and study plan

Victoza® (liraglutide)

Drug

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Placebo

Drug

Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.

Primary outcomes

  1. Serum C-peptide AUC

    Time frame: From baseline to 26 and 52 weeks

    Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)

Secondary outcomes

  1. Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored

    Time frame: From baseline to 26 and 52 weeks

    Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period

  2. Number of hypoglycemia episodes

    Time frame: From baseline to 26 and 52 weeks

    Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period

  3. Frequency of gastrointestinal side effects

    Time frame: 12 months

    Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period

  4. Insulin dose

    Time frame: From baseline to 26 and 52 weeks

    Insulin dose IU/kg/day

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 20, 2016
Registry last updated
Jan 11, 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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