Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections

Sponsor
Vastra Gotaland Region
Study ID
NCT02113332
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight. However, to date there are no clinical trials of liraglutide added to insulin therapy, a population of patients generally having worse glycaemic control and weight gain. In clinical guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic option for type 2 diabetic patients. The primary study aim is to evaluate whether the addition of liraglutide, compared to placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is defined as treatment with any basal insulin combined with separate meal time insulin injections before the main meals, i.e. an insulin regimen with premixed insulin is not considered as MDI. The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.

Key Dates

Start date
Jan 31, 2013
Status verified
Dec 2014
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: Liraglutide
    Liraglutide injected once per day for 24 weeks. Dose is 1,8 mg or highest tolerable dose.
  • Placebo Comparator: Placebo
    Placebo injected once per day for 24 weeks. Dose is 1,8 or highest tolerable dose.

Primary Outcome Measure

Change in HbA1c from baseline to week 24. [ Time Frame: Baseline, week 24 ]

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