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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

Tracking Information
First Submitted Date  ICMJE November 20, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02617654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Drug: Liraglutide
    Treatment with liraglutide for 52 weeks
  • Drug: Placebo for liraglutide
    Placebo for liraglutide. Treatment once daily for 52 weeks
Study Arms  ICMJE
  • Active Comparator: Liraglutide treatment
    Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Placebo treatment
    Treatment with placebo once daily for 52 weeks
    Intervention: Drug: Placebo for liraglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tomas Skommevik, MD +46 18 611 00 00 tomas.skommevik@akademiska.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02617654
Other Study ID Numbers  ICMJE U1111-1166-6923
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per-Ola Carlsson, Uppsala University Hospital
Study Sponsor  ICMJE Per-Ola Carlsson
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Per-Ola Carlsson, MD, PhD Uppsala University Hospital
PRS Account Uppsala University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP