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

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ClinicalTrials.gov Identifier: NCT02617654
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Liraglutide Drug: Placebo for liraglutide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide treatment
Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks
Drug: Liraglutide
Treatment with liraglutide for 52 weeks

Placebo Comparator: Placebo treatment
Treatment with placebo once daily for 52 weeks
Drug: Placebo for liraglutide
Placebo for liraglutide. Treatment once daily for 52 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent for participation of the study, given before undergoing any study-specific procedures.
  2. 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
  3. Clinical diagnose of T1D
  4. Five or more years duration of disease
  5. HbA1C between 45 and 75 mmol/mol
  6. Fasting plasma C-peptide concentration >1.5 pmol/l.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617654


Contacts
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Contact: Tomas Skommevik, MD +46 18 611 00 00 tomas.skommevik@akademiska.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-75185
Contact: Tomas Skommevik, MD    +46 18 611 0000    tomas.skommevik@akademiska.se   
Sponsors and Collaborators
Per-Ola Carlsson
Investigators
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Principal Investigator: Per-Ola Carlsson, MD, PhD Uppsala University Hospital

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Responsible Party: Per-Ola Carlsson, Professor, senior consultant, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT02617654     History of Changes
Other Study ID Numbers: U1111-1166-6923
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists