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

This study has been terminated.
(Error made by local pharmacy caused mixed randomization of 20 participants)
Novo Nordisk A/S
Information provided by (Responsible Party):
Dr. Vincent Woo, University of Manitoba Identifier:
First received: June 21, 2012
Last updated: January 20, 2016
Last verified: January 2016
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%.

Condition Intervention Phase
Type 2 Diabetes
Drug: liraglutide
Drug: placebo injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Resource links provided by NLM:

Further study details as provided by Dr. Vincent Woo, University of Manitoba:

Primary Outcome Measures:
  • Change in A1c [ Time Frame: Baseline to 24 wks ]

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

Enrollment: 52
Study Start Date: August 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: liraglutide
liraglutide 1.8 mg injected once daily
Drug: liraglutide
liraglutide titrated to 1.8 mg sc daily
Other Name: Victoza
Placebo Comparator: Placebo injection Drug: placebo injection
placebo injected sc daily volume equal to active comparator
Other Name: Placebo


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01628445

Canada, Manitoba
Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group
Winnipeg, Manitoba, Canada, R3E3P4
Sponsors and Collaborators
University of Manitoba
Novo Nordisk A/S
Principal Investigator: Vincent C Woo, MD FRCPC University of Mantioba
  More Information

Responsible Party: Dr. Vincent Woo, Assistant Professor, University of Manitoba Identifier: NCT01628445     History of Changes
Other Study ID Numbers: U1111-1126-3937
Study First Received: June 21, 2012
Last Updated: January 20, 2016

Keywords provided by Dr. Vincent Woo, University of Manitoba:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017