Type 2 DiabetesPhase 3SAILNCT01628445
Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
A Phase 3 study testing liraglutide in people with Type 2 Diabetes, run by University of Manitoba at 1 site in Canada.
Trial summary
Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Nov 2015
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- BMI≤45 kg/m2
- A1c ≥7.5% and ≤10.5%
Who cannot join
- type 1 diabetes
- symptoms of poorly controlled diabetes
- eGFR <50 ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
Canada1 site
Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group
Winnipeg, Manitoba, R3E3P4
About this study
Official title: Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.
- Conditions
- Type 2 Diabetes
- Being tested
- liraglutide, placebo injection
- Keywords
- Diabetes, Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, 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 titrated to 1.8 mg sc daily
placebo injectionDrug
Also called Placebo
placebo injected sc daily volume equal to active comparator
| Study group | Role | What they receive |
|---|---|---|
| liraglutide | Active comparator | liraglutide 1.8 mg injected once daily Receives: Drug: liraglutide |
| Placebo injection | Placebo comparator | Not described Receives: Drug: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c
Measured: Baseline to 24 wks
Secondary outcomes (12)
Percentage of patients experiencing hypoglycemia
Measured: Baseline and 24 weeks
Change in Systolic Blood pressure
Measured: Baseline and 24 weeks
Change in diastolic blood pressure
Measured: Baseline and 24 weeks
Change in waist circumference
Measured: Baseline and 24 weeks
Change in body weight
Measured: Baseline and 24 weeks
Change in heart rate
Measured: Baseline and 24 weeks
Change in lipid profile
Measured: Baseline and 24 weeks
Diabetes Treatment Satisfaction
Measured: Baseline, 12 weeks and 24 weeks
Percentage of patients achieving A1C < or equal to 7%
Measured: Baseline and 24 weeks
Change in fasting blood glucose
Measured: Baseline adn 24 weeks
Occurence of undetected hypoglycemia as measured by continuous glucose monitoring
Measured: Baseline, 12 weeks and 24 weeks
Postprandial glucose reduction through measurement of 7 point glucose profile
Measured: Baseline, 4 weeks, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Error made by local pharmacy caused mixed randomization of 20 participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Dr. Vincent Woo, University of Manitoba
- Investigators
- Vincent C Woo, MD FRCPC, Principal investigator, University of Mantioba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628445
- Sponsor's protocol ID
- U1111-1126-3937
- Acronym
- SAIL
- Status last verified
- Jan 2016
- First submitted
- 21 Jun 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
- ClinicalTrials.gov ID
- NCT01628445
- Acronym / sponsor ID
- SAIL / U1111-1126-3937
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Error made by local pharmacy caused mixed randomization of 20 participants
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Jun 2012 (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.
Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.
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: liraglutideliraglutide 1.8 mg injected once daily |
| Placebo injection | Placebo comparator | Drug: placebo injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- BMI≤45 kg/m2
- A1c ≥7.5% and ≤10.5%
Key exclusion criteria (3 listed)
- type 1 diabetes
- symptoms of poorly controlled diabetes
- eGFR <50 ml/min/1.73m2
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 titrated to 1.8 mg sc daily | Drug | liraglutide |
| placebo injectionAlso: Placeboplacebo injected sc daily volume equal to active comparator | Drug | Placebo injection |
Primary outcome
Change in A1c
Time frame: Baseline to 24 wks
12 secondary outcomes
Percentage of patients experiencing hypoglycemia
Time frame: Baseline and 24 weeks
Change in Systolic Blood pressure
Time frame: Baseline and 24 weeks
Change in diastolic blood pressure
Time frame: Baseline and 24 weeks
Change in waist circumference
Time frame: Baseline and 24 weeks
Change in body weight
Time frame: Baseline and 24 weeks
Change in heart rate
Time frame: Baseline and 24 weeks
Change in lipid profile
Time frame: Baseline and 24 weeks
Diabetes Treatment Satisfaction
Time frame: Baseline, 12 weeks and 24 weeks
Percentage of patients achieving A1C < or equal to 7%
Time frame: Baseline and 24 weeks
Change in fasting blood glucose
Time frame: Baseline adn 24 weeks
Occurence of undetected hypoglycemia as measured by continuous glucose monitoring
Time frame: Baseline, 12 weeks and 24 weeks
Postprandial glucose reduction through measurement of 7 point glucose profile
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
Results and safety
The study was stopped early (reason given: Error made by local pharmacy caused mixed randomization of 20 participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
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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.
Vincent C Woo, MD FRCPC principal investigator
University of Mantioba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide in people with Type 2 Diabetes, run by University of Manitoba 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Jan 2016. 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 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 was stopped early (reason given: Error made by local pharmacy caused mixed randomization of 20 participants). Results are not available in the source record.
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?
Change in A1c (time frame: Baseline to 24 wks). 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 21 Jan 2016.