A Phase 3 interventional study of liraglutide and placebo injection in Type 2 Diabetes, sponsored by University of Manitoba. Terminated at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-21.
Sponsored by University of Manitoba · Phase 3, Interventional, and Treatment
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%.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 52 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
liraglutide 1.8 mg injected once daily
Drug: liraglutide
Drug: placebo injection
liraglutide titrated to 1.8 mg sc daily
Also known as: Victoza
placebo injected sc daily volume equal to active comparator
Also known as: Placebo
Change in A1c
Time frame: Baseline to 24 wks
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
This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Manitoba