Type 1 DiabetesPhase 2NCT02617654
Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes
A Phase 2 study testing Liraglutide in people with Type 1 Diabetes, run by Per-Ola Carlsson at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2015to Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Liraglutide, Placebo for liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Treatment with liraglutide for 52 weeks
Placebo for liraglutideDrug
Placebo for liraglutide. Treatment once daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide treatment | Active comparator | Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks Receives: Drug: Liraglutide |
| Placebo treatment | Placebo comparator | Treatment with placebo once daily for 52 weeks Receives: Drug: Placebo for liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 52 weeks
Secondary outcomes (17)
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
Measured: 52 weeks
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
Measured: 52 weeks
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.
Measured: 52 weeks
Change in HbA1c between 6 and 52 weeks of study
∆- change in HbA1c between after one year and after 6 weeks of treatment
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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
Measured: 52 weeks
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per-Ola Carlsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per-Ola Carlsson, Uppsala University Hospital
- Investigators
- Per-Ola Carlsson, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617654
- Sponsor's protocol ID
- U1111-1166-6923
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2015
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02617654
- Acronym / sponsor ID
- U1111-1166-6923
- Conditions
- Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Per-Ola CarlssonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide treatment | Active comparator | Drug: LiraglutideLiraglutide treatment in the dose of 1.8 mg daily for 52 weeks |
| Placebo treatment | Placebo comparator | Drug: Placebo for liraglutideTreatment with placebo once daily for 52 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideTreatment with liraglutide for 52 weeks | Drug | Liraglutide treatment |
| Placebo for liraglutidePlacebo for liraglutide. Treatment once daily for 52 weeks | Drug | Placebo treatment |
Primary outcome
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)
17 secondary outcomes
Change in C-peptide between 6 and 52 weeks of study
Time frame: 52 weeks
Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg
Time frame: 52 weeks
Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment
Time frame: 52 weeks
Change in HbA1c between 6 and 52 weeks of study
Time frame: 52 weeks
Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg
Time frame: 52 weeks
Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment
Time frame: 52 weeks
Change in insulin doses between 6 and 52 weeks of study
Time frame: 52 weeks
Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg
Time frame: 52 weeks
Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment
Time frame: 52 weeks
Change in glucose variability between 6 and 52 weeks of study
Time frame: 52 weeks
Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg
Time frame: 52 weeks
Change in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment
Time frame: 52 weeks
Change in hypoglycemia frequency between 6 and 52 weeks of study
Time frame: 52 weeks
Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg
Time frame: 52 weeks
Change in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg)
Time frame: 52 weeks
Change in QoL between 6 and 52 weeks of study
Time frame: 52 weeks
Change in QoL between after and prior to treatment with liraglutide
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per-Ola Carlsson, MD, PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide in people with Type 1 Diabetes, run by Per-Ola Carlsson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.