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Completed

NCT Number: NCT02617654

Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes

Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells.

The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.

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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

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Uppsala University Hospital

Uppsala, SE-75185, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent for participation of the study, given before undergoing any study-specific procedures.
  • 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
  • Clinical diagnose of T1D
  • Five or more years duration of disease
  • HbA1C between 45 and 75 mmol/mol
  • Fasting plasma C-peptide concentration >1.5 pmol/l.

Exclusion criteria

  • Inability to provide informed consent
  • Mental incapacity
  • Unwillingness or language barrier precluding adequate understanding or cooperation
  • Ongoing or planned pregnancy within the next 12 months
  • Inadequate or no use of contraceptives
  • Ongoing breast feeding
  • Known sight-threatening retinopathy
  • Creatinine clearance <60 ml/min
  • Life-threatening cardiovascular disease
  • History of drug/alcohol abuse
  • Known or suspected allergy to trial product or related product
  • Recurrent assisted hypoglycemias
  • Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
  • Uncontrolled hypertension (180/105 mmHg or above)
  • History of acute or chronic pancreatitis
  • Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
  • Personal history of non-familial medullary thyroid carcinoma.
  • Any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results

Treatment and study plan

liraglutide

Drug

Treatment with liraglutide for 52 weeks

Placebo for liraglutide

Drug

Placebo for liraglutide. Treatment once daily for 52 weeks

Primary outcomes

  1. The effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production

    Time frame: 52 weeks

    The Area Under the Curve (AUC) change in plasma C-peptide concentration in response to a standardized mixed meal tolerance test (MMTT) during one year of liraglutide treatment (1.8 mg/day)

Secondary outcomes

  1. Change in C-peptide between 6 and 52 weeks of study

    Time frame: 52 weeks

    ∆- change in C-peptide AUC between the MMTT after one year and that after 6 weeks of treatment

  2. Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg

    Time frame: 52 weeks

    ∆-change in C-peptide AUC between the MMTT three months after cessation of treatment and that after the run-in period

  3. Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment

    Time frame: 52 weeks

    ∆- change in HbA1c between after one year and after the run-in period.

  4. Change in HbA1c between 6 and 52 weeks of study

    Time frame: 52 weeks

    ∆- change in HbA1c between after one year and after 6 weeks of treatment

  5. Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg

    Time frame: 52 weeks

    ∆- change in HbA1c between three months after the cessation of treatment and after the run-in period.

  6. Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment

    Time frame: 52 weeks

    ∆- change in exogenous insulin doses between after one year and after the run-in period.

  7. Change in insulin doses between 6 and 52 weeks of study

    Time frame: 52 weeks

    ∆- change in exogenous insulin doses between after one year and after 6 weeks of treatment

  8. Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg

    Time frame: 52 weeks

    ∆- change in exogenous insulin doses between three months after the cessation of treatment and after the run-in period.

  9. Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment

    Time frame: 52 weeks

    ∆- change in glucose variability between after one year and after the run-in period.

  10. Change in glucose variability between 6 and 52 weeks of study

    Time frame: 52 weeks

    ∆- change in glucose variability between after one year and after 6 weeks of treatment

  11. Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg

    Time frame: 52 weeks

    ∆- change in glucose variability between three months after the cessation of treatment and after the run-in period.

  12. Change in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment

    Time frame: 52 weeks

    ∆- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) between one year and after the run-in period.

  13. Change in hypoglycemia frequency between 6 and 52 weeks of study

    Time frame: 52 weeks

    ∆- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) after one year and after 6 weeks of treatment

  14. Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg

    Time frame: 52 weeks

    ∆- change in hypoglycemia frequency (measured plasma glucose levels < 3 mmol/l or assisted hypoglycemia during a one week period) between three months after the cessation of treatment and after the run-in period.

  15. Change in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg)

    Time frame: 52 weeks

    ∆- change in assessment of QoL between after one year and after the run-in period.

  16. Change in QoL between 6 and 52 weeks of study

    Time frame: 52 weeks

    ∆- change in assessment of QoL between after one year and after 6 weeks of treatment

  17. Change in QoL between after and prior to treatment with liraglutide

    Time frame: 52 weeks

    ∆- change in assessment of QoL between three months after the cessation of treatment and after the run-in period.

Sponsors and collaborators

Lead sponsor

Per-Ola Carlsson

Other

Registry information

Official study title

A Randomized, Double-blinded Placebo-controlled, Paralleled Designed, Investigator Sponsored Study of the Effect of the GLP-1 Receptor Agonist Liraglutide on Beta-cell Function in C-peptide Positive Type 1 Diabetic Patients

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2015
Registry last updated
Nov 5, 2020

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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