Back to resultsStudy of Liraglutide in Individuals With Type 2 Diabetes Using Insulin (SAIL)
Primary Purpose
Type 2 Diabetes
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
liraglutide
placebo injection
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Insulin
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- BMI≤45 kg/m2
- A1c ≥7.5% and ≤10.5%
Exclusion Criteria:
- type 1 diabetes
- symptoms of poorly controlled diabetes
- eGFR <50 ml/min/1.73m2
Sites / Locations
- Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
liraglutide
Placebo injection
Arm Description
liraglutide 1.8 mg injected once daily
Outcomes
Primary Outcome Measures
Change in A1c
Secondary Outcome Measures
Percentage of patients experiencing hypoglycemia
Change in Systolic Blood pressure
Change in diastolic blood pressure
Change in waist circumference
Change in body weight
Change in heart rate
Change in lipid profile
Diabetes Treatment Satisfaction
Percentage of patients achieving A1C < or equal to 7%
Change in fasting blood glucose
Occurence of undetected hypoglycemia as measured by continuous glucose monitoring
Postprandial glucose reduction through measurement of 7 point glucose profile
Full Information
NCT ID
NCT01628445
First Posted
June 21, 2012
Last Updated
January 20, 2016
Sponsor
University of Manitoba
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT01628445
Brief Title
Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
Acronym
SAIL
Official Title
Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Error made by local pharmacy caused mixed randomization of 20 participants
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liraglutide
Arm Type
Active Comparator
Arm Description
liraglutide 1.8 mg injected once daily
Arm Title
Placebo injection
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
liraglutide titrated to 1.8 mg sc daily
Intervention Type
Drug
Intervention Name(s)
placebo injection
Other Intervention Name(s)
Placebo
Intervention Description
placebo injected sc daily volume equal to active comparator
Primary Outcome Measure Information:
Title
Change in A1c
Time Frame
Baseline to 24 wks
Secondary Outcome Measure Information:
Title
Percentage of patients experiencing hypoglycemia
Time Frame
Baseline and 24 weeks
Title
Change in Systolic Blood pressure
Time Frame
Baseline and 24 weeks
Title
Change in diastolic blood pressure
Time Frame
Baseline and 24 weeks
Title
Change in waist circumference
Time Frame
Baseline and 24 weeks
Title
Change in body weight
Time Frame
Baseline and 24 weeks
Title
Change in heart rate
Time Frame
Baseline and 24 weeks
Title
Change in lipid profile
Time Frame
Baseline and 24 weeks
Title
Diabetes Treatment Satisfaction
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Percentage of patients achieving A1C < or equal to 7%
Time Frame
Baseline and 24 weeks
Title
Change in fasting blood glucose
Time Frame
Baseline adn 24 weeks
Title
Occurence of undetected hypoglycemia as measured by continuous glucose monitoring
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Postprandial glucose reduction through measurement of 7 point glucose profile
Time Frame
Baseline, 4 weeks, 12 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
BMI≤45 kg/m2
A1c ≥7.5% and ≤10.5%
Exclusion Criteria:
type 1 diabetes
symptoms of poorly controlled diabetes
eGFR <50 ml/min/1.73m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent C Woo, MD FRCPC
Organizational Affiliation
University of Mantioba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E3P4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
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