Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin (SAIL)

University of Manitoba

Status and phase: Terminated; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: liraglutide; Drug: placebo injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01628445

U1111-1126-3937

Details and patient eligibility

About

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%.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

liraglutide

Active Comparator group

Description:

liraglutide 1.8 mg injected once daily

Treatment:

Drug: liraglutide

Placebo injection

Placebo Comparator group

Treatment:

Drug: placebo injection