Diabetes Mellitus, Type 1Phase 2/3NewLiraNCT01879917
Liraglutide in Newly Onset Type 1 Diabetes.
A Phase 2/3 study testing Liraglutide in people with Diabetes Mellitus, Type 1, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Aug 2018
- Phase
- Phase 2/3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
- Age 18 - 40 years - both inclusive
- Postprandial C-peptide > 0.2 nmol/l following sustacal meal test
- Able to understand the written patient information and to give informed consent
Who cannot join
- Type 2 diabetes
- Body mass index <20 kg/m2
- Pregnancy or unwillingness to use safe contraceptives
- Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. of Endocrinology, Hvidovre University Hospital
Hvidovre, Capital, 2650
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.
The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Liraglutide, Placebo
- Keywords
- c-peptide, insulin, hypoglycemia, Newly onset, Diabetes, Type 1, Beta cell, Autoimmune, Glucagon, Meal test
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | 1.8 mg Receives: Drug: Liraglutide |
| Saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell function
To investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
Measured: 52 weeks
Secondary outcomes (1)
Postprandial glucagon
To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in Postprandial glucagon levels following sustacal meal test.
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 posted18 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Hillerod Hospital, Denmark, Bispebjerg Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Principal investigator, Thomas Dejgaard, Hvidovre University Hospital
- Investigators
- Sten Madsbad, Professor, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879917
- Sponsor's protocol ID
- 2012-005317-39
- Other IDs
- 2012-005317-39, U1111-1137-3221
- Acronym
- NewLira
- Status last verified
- Mar 2021
- First submitted
- 14 Jun 2013
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT01879917
- Acronym / sponsor ID
- NewLira / 2012-005317-39
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- c-peptide, insulin, hypoglycemia, Newly onset, Diabetes, Type 1, Beta cell, Autoimmune
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Hillerod Hospital, Denmark, Bispebjerg Hospital, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Jun 2013 (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.
The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: Liraglutide1.8 mg |
| Saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
- Age 18 - 40 years - both inclusive
- Postprandial C-peptide > 0.2 nmol/l following sustacal meal test
- Able to understand the written patient information and to give informed consent
Key exclusion criteria (5 listed)
- Type 2 diabetes
- Body mass index <20 kg/m2
- Pregnancy or unwillingness to use safe contraceptives
- Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0
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 |
|---|---|---|
| LiraglutideAlso: Victoza | Drug | Liraglutide |
| PlaceboSaline | Drug | Saline |
Primary outcome
Beta-cell function
Time frame: 52 weeks
To investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
1 secondary outcome
Postprandial glucagon
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 30 Mar 2021.
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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.
Sten Madsbad, Professor study director
Hvidovre 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 2/3 study testing Liraglutide in people with Diabetes Mellitus, Type 1, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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 30 Mar 2021. 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 Denmark. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Beta-cell function (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 30 Mar 2021.