Type 1 DiabetesPhase 4LIDONCT01787916
52 Week Trial of Liraglutide in Type 1 Diabetes
A Phase 4 study testing Liraglutide in people with Type 1 Diabetes, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Read more about this study
- Who is it for?
- Ages 18 to 50 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
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years
Who cannot join
- diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.
Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
Read the detailed description
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
- Conditions
- Type 1 Diabetes
- Being tested
- Liraglutide, Placebos
- Keywords
- type 1 diabetes, overweight, insulin, liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 1, Overweight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
PlacebosDrug
placebo will be compared to liraglutide for 24 weeks in a cross-over design
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Liraglutide, s.c., 1.8 mg, die, 24 weeks Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Changes in Glycemic Control by HbA1c.
To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.
Measured: Measure changes in HbA1c at 24 and 52 weeks from baseline
Secondary outcomes (1)
Assessment of Changes on Adipose Tissue
To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue
Measured: Measure changes in the composite at 24 and 52 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Stanley John Weisnagel, MD, Principal investigator, CHU de QuébecMartin D'Amours, MD, Principal investigator, CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787916
- Sponsor's protocol ID
- 2013LIDO
- Acronym
- LIDO
- Status last verified
- Mar 2014
- First submitted
- 4 Feb 2013
- Last updated
- 5 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: individual data will not be available to other researchers
Publications
Dube MC, D'Amours M, Weisnagel SJ. Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):178-184. doi: 10.1111/dom.13063. Epub 2017 Sep 6.
PubMed 28722271
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT01787916
- Acronym / sponsor ID
- LIDO / 2013LIDO
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, overweight, insulin, liraglutide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 5 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.
Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
Detailed description
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideLiraglutide, s.c., 1.8 mg, die, 24 weeks |
| Placebo | Placebo comparator | Drug: PlacebosLiraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years
Key exclusion criteria (1 listed)
- diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
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: VictozaLiraglutide will be compared to placebo for 24 weeks in a cross-over design | Drug | Liraglutide |
| Placebosplacebo will be compared to liraglutide for 24 weeks in a cross-over design | Drug | Placebo |
Primary outcome
Assessment of Changes in Glycemic Control by HbA1c.
Time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline
To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.
1 secondary outcome
Assessment of Changes on Adipose Tissue
Time frame: Measure changes in the composite at 24 and 52 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28722271Dube MC, D'Amours M, Weisnagel SJ. Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):178-184. doi: 10.1111/dom.13063. Epub 2017 Sep 6.
- Individual participant dataSharing planned: No. individual data will not be available to other researchers
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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.
Stanley John Weisnagel, MD principal investigator
CHU de Québec
Martin D'Amours, MD principal investigator
CHU de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Type 1 Diabetes, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 1 inclusion and 1 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 Jan 2018. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Changes in Glycemic Control by HbA1c. (time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787916, which also lists 1 linked publication.
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 Jan 2018.