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

This study is currently recruiting participants.
Verified August 2012 by University of Manitoba
Sponsor:
Collaborator:
Novo Nordisk
Information provided by (Responsible Party):
Dr. Vincent Woo, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01628445
First received: June 21, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in A1c [ Time Frame: Baseline to 24 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients experiencing hypoglycemia [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in Systolic Blood pressure [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in diastolic blood pressure [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in heart rate [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in lipid profile [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Diabetes Treatment Satisfaction [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving A1C < or equal to 7% [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose [ Time Frame: Baseline adn 24 weeks ] [ Designated as safety issue: No ]
  • Occurence of undetected hypoglycemia as measured by continuous glucose monitoring [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
  • Postprandial glucose reduction through measurement of 7 point glucose profile [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2012
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628445

Locations
Canada, Manitoba
Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group Recruiting
Winnipeg, Manitoba, Canada, R3E3P4
Contact: Lori D Berard, RN     2047893228     lberard@hsc.mb.ca    
Contact: Auralee Winterburn     2047893433     awinterburn@hsc.mb.ca    
Sponsors and Collaborators
University of Manitoba
Novo Nordisk
Investigators
Principal Investigator: Vincent C Woo, MD FRCPC University of Mantioba
  More Information

No publications provided

Responsible Party: Dr. Vincent Woo, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01628445     History of Changes
Other Study ID Numbers: U1111-1126-3937
Study First Received: June 21, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Diabetes
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Glucagon-Like Peptide 1
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013