Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01628445

Acronym

SAIL

Enrollment

Registered

2012-06-26

Start date

2012-08-31

Completion date

2015-11-30

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes, Insulin

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%.

Interventions

DRUGliraglutide

liraglutide titrated to 1.8 mg sc daily

DRUGplacebo injection

placebo injected sc daily volume equal to active comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change in A1c	Baseline to 24 wks

Secondary

Measure	Time frame
Change in Systolic Blood pressure	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
Percentage of patients experiencing hypoglycemia	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
Change in lipid profile	Baseline and 24 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026