Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Phase 3

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Drug: placebo injection; Drug: liraglutide

• Registration Number: NCT01628445
• Lead Sponsor: University of Manitoba

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-26
• Study Start: 2012-08
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	placebo injection	-
liraglutide	liraglutide	liraglutide 1.8 mg injected once daily

Primary Outcome Measures

Name	Time	Method
Change in A1c	Baseline to 24 wks

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood pressure	Baseline and 24 weeks
Percentage of patients experiencing hypoglycemia	Baseline and 24 weeks
Change in diastolic blood pressure	Baseline and 24 weeks
Change in waist circumference	Baseline and 24 weeks
Change in body weight	Baseline and 24 weeks
Change in heart rate	Baseline and 24 weeks
Change in lipid profile	Baseline and 24 weeks
Diabetes Treatment Satisfaction	Baseline, 12 weeks and 24 weeks
Percentage of patients achieving A1C < or equal to 7%	Baseline and 24 weeks
Change in fasting blood glucose	Baseline adn 24 weeks
Occurence of undetected hypoglycemia as measured by continuous glucose monitoring	Baseline, 12 weeks and 24 weeks
Postprandial glucose reduction through measurement of 7 point glucose profile	Baseline, 4 weeks, 12 weeks and 24 weeks

Trial Locations

Locations (1)

Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group; 🇨🇦 Winnipeg, Manitoba, Canada