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

January 20, 2016 updated by: Dr. Vincent Woo, University of Manitoba

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

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%.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E3P4
        • Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo injection
Drug: placebo injection
placebo injected sc daily volume equal to active comparator
Other Names:
  • Placebo
Active Comparator: liraglutide
liraglutide 1.8 mg injected once daily
Drug: liraglutide
liraglutide titrated to 1.8 mg sc daily
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in A1c
Time Frame: Baseline to 24 wks
Baseline to 24 wks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Vincent C Woo, MD FRCPC, University of Mantioba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1126-3937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on liraglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe