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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Manitoba
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Dr. Vincent Woo, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01628445
First received: June 21, 2012
Last updated: July 31, 2014
Last verified: July 2014
  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:


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
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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

  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
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 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 A/S
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: July 31, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Diabetes
Insulin

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

ClinicalTrials.gov processed this record on October 20, 2014