Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Type 2 Diabetes Clinical Trial

— SAIL  

Official title:

Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01628445
• Other study ID #: U1111-1126-3937
• Status: Terminated
• Phase: Phase 3
• First received: June 21, 2012
• Last updated: January 20, 2016
• Start date: August 2012
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• liraglutide
liraglutide titrated to 1.8 mg sc daily
• placebo injection
placebo injected sc daily volume equal to active comparator

Locations

Country	Name	City	State
Canada	Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1c		Baseline to 24 wks	No
Secondary	Percentage of patients experiencing hypoglycemia		Baseline and 24 weeks	Yes
Secondary	Change in Systolic Blood pressure		Baseline and 24 weeks	Yes
Secondary	Change in diastolic blood pressure		Baseline and 24 weeks	No
Secondary	Change in waist circumference		Baseline and 24 weeks	No
Secondary	Change in body weight		Baseline and 24 weeks	No
Secondary	Change in heart rate		Baseline and 24 weeks	No
Secondary	Change in lipid profile		Baseline and 24 weeks	No
Secondary	Diabetes Treatment Satisfaction		Baseline, 12 weeks and 24 weeks	No
Secondary	Percentage of patients achieving A1C < or equal to 7%		Baseline and 24 weeks	No
Secondary	Change in fasting blood glucose		Baseline adn 24 weeks	No
Secondary	Occurence of undetected hypoglycemia as measured by continuous glucose monitoring		Baseline, 12 weeks and 24 weeks	Yes
Secondary	Postprandial glucose reduction through measurement of 7 point glucose profile		Baseline, 4 weeks, 12 weeks and 24 weeks	No