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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Liraglutide
Placebo for liraglutide
Sponsored by
Per-Ola Carlsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Liraglutide treatment

Placebo treatment

Arm Description

Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks

Treatment with placebo once daily for 52 weeks

Outcomes

Primary Outcome Measures

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
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

Change in C-peptide between 6 and 52 weeks of study
∆- 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
∆-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
∆- change in HbA1c between after one year and after the run-in period.
Change in HbA1c between 6 and 52 weeks of study
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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
∆- 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)
∆- 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
∆- 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
∆- change in assessment of QoL between three months after the cessation of treatment and after the run-in period.

Full Information

First Posted
November 20, 2015
Last Updated
November 4, 2020
Sponsor
Per-Ola Carlsson
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1. Study Identification

Unique Protocol Identification Number
NCT02617654
Brief Title
Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per-Ola Carlsson

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide treatment
Arm Type
Active Comparator
Arm Description
Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
Treatment with liraglutide for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo for liraglutide
Intervention Description
Placebo for liraglutide. Treatment once daily for 52 weeks
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change in C-peptide between 6 and 52 weeks of study
Description
∆- change in C-peptide AUC between the MMTT after one year and that after 6 weeks of treatment
Time Frame
52 weeks
Title
Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg
Description
∆-change in C-peptide AUC between the MMTT three months after cessation of treatment and that after the run-in period
Time Frame
52 weeks
Title
Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment
Description
∆- change in HbA1c between after one year and after the run-in period.
Time Frame
52 weeks
Title
Change in HbA1c between 6 and 52 weeks of study
Description
∆- change in HbA1c between after one year and after 6 weeks of treatment
Time Frame
52 weeks
Title
Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg
Description
∆- change in HbA1c between three months after the cessation of treatment and after the run-in period.
Time Frame
52 weeks
Title
Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment
Description
∆- change in exogenous insulin doses between after one year and after the run-in period.
Time Frame
52 weeks
Title
Change in insulin doses between 6 and 52 weeks of study
Description
∆- change in exogenous insulin doses between after one year and after 6 weeks of treatment
Time Frame
52 weeks
Title
Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg
Description
∆- change in exogenous insulin doses between three months after the cessation of treatment and after the run-in period.
Time Frame
52 weeks
Title
Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment
Description
∆- change in glucose variability between after one year and after the run-in period.
Time Frame
52 weeks
Title
Change in glucose variability between 6 and 52 weeks of study
Description
∆- change in glucose variability between after one year and after 6 weeks of treatment
Time Frame
52 weeks
Title
Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg
Description
∆- change in glucose variability between three months after the cessation of treatment and after the run-in period.
Time Frame
52 weeks
Title
Change in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment
Description
∆- 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.
Time Frame
52 weeks
Title
Change in hypoglycemia frequency between 6 and 52 weeks of study
Description
∆- 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
Time Frame
52 weeks
Title
Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg
Description
∆- 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.
Time Frame
52 weeks
Title
Change in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg)
Description
∆- change in assessment of QoL between after one year and after the run-in period.
Time Frame
52 weeks
Title
Change in QoL between 6 and 52 weeks of study
Description
∆- change in assessment of QoL between after one year and after 6 weeks of treatment
Time Frame
52 weeks
Title
Change in QoL between after and prior to treatment with liraglutide
Description
∆- change in assessment of QoL between three months after the cessation of treatment and after the run-in period.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Ola Carlsson, MD, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden

12. IPD Sharing Statement

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

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