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 A/S
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

June 21, 2012
August 14, 2012
August 2012
Not Provided
Change in A1c [ Time Frame: Baseline to 24 wks ] [ Designated as safety issue: No ]
The primary endpoint will be a change in A1c [ Time Frame: 24 wks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01628445 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Weight, waist circumference, BP, heart rate, lipid profile, episodes of hypoglycemia,DTSQ, percentage of patient achieveing HbA1C < 7.0%, change in FBG from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Change in weight and waist circumference Change in Blood pressure and heart rate Change in lipid profile Percentage of patients experiencing hypoglycemia Diabetes Treatment Satisfaction Percentage of patients achieving A1c<7.0% Change in FBG from baseline Postprandial glucose reduction as measured through 7 point profile Percentage of patients experiencing asymptomatic hypoglycemia as measured by CGMS
  • Waist circumference, weight, BP, pulse, hypoglycemia episodes, postprandial glucose levels, quality of life, [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Change in weight and waist circumference Change in Blood pressure and heart rate Change in lipid profile Percentage of patients experiencing hypoglycemia Quality of life Percentage of patients achieving A1c<7.0% Change in FBG from baseline Postprandial glucose reduction as measured through 7 point profile Percentage of patients experiencing asymptomatic hypoglycemia as measured by CGMS
Not Provided
Not Provided
 
Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
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%.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: liraglutide
    liraglutide titrated to 1.8 mg sc daily
    Other Name: Victoza
  • Drug: placebo injection
    placebo injected sc daily volume equal to active comparator
    Other Name: Placebo
  • Active Comparator: liraglutide
    liraglutide 1.8 mg injected once daily
    Intervention: Drug: liraglutide
  • Placebo Comparator: Placebo injection
    Intervention: Drug: placebo injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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
Both
18 Years to 80 Years
No
Not Provided
Canada
 
NCT01628445
U1111-1126-3937
No
Dr. Vincent Woo, University of Manitoba
University of Manitoba
Novo Nordisk A/S
Principal Investigator: Vincent C Woo, MD FRCPC University of Mantioba
University of Manitoba
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP