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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628445
Recruitment Status : Terminated (Error made by local pharmacy caused mixed randomization of 20 participants)
First Posted : June 26, 2012
Last Update Posted : January 21, 2016
Novo Nordisk A/S
Information provided by (Responsible Party):
Dr. Vincent Woo, 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%.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: liraglutide Drug: placebo injection Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
Study Start Date : August 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Percentage of patients experiencing hypoglycemia [ Time Frame: Baseline and 24 weeks ]
  2. Change in Systolic Blood pressure [ Time Frame: Baseline and 24 weeks ]
  3. Change in diastolic blood pressure [ Time Frame: Baseline and 24 weeks ]
  4. Change in waist circumference [ Time Frame: Baseline and 24 weeks ]
  5. Change in body weight [ Time Frame: Baseline and 24 weeks ]
  6. Change in heart rate [ Time Frame: Baseline and 24 weeks ]
  7. Change in lipid profile [ Time Frame: Baseline and 24 weeks ]
  8. Diabetes Treatment Satisfaction [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  9. Percentage of patients achieving A1C < or equal to 7% [ Time Frame: Baseline and 24 weeks ]
  10. Change in fasting blood glucose [ Time Frame: Baseline adn 24 weeks ]
  11. Occurence of undetected hypoglycemia as measured by continuous glucose monitoring [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  12. Postprandial glucose reduction through measurement of 7 point glucose profile [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dr. Vincent Woo, Assistant Professor, University of Manitoba Identifier: NCT01628445     History of Changes
Other Study ID Numbers: U1111-1126-3937
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 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