Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Sponsor
University of Manitoba
Study ID
NCT01628445
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    liraglutide titrated to 1.8 mg sc daily
  • placebo injection — DRUG
    placebo injected sc daily volume equal to active comparator

Study Details

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%.

Key Dates

Start date
Aug 31, 2012
Status verified
Jan 2016
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: liraglutide
    liraglutide 1.8 mg injected once daily
  • Placebo Comparator: Placebo injection

Primary Outcome Measure

Change in A1c [ Time Frame: Baseline to 24 wks ]

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