Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01518101
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vildagliptin/ Metformin — DRUG
    Single pill combination of Vildagliptin/ Metformin (50/1000 mg).
  • Liraglutide — DRUG
    1.2 mg once daily by commercially available injection pens
  • Metformin — DRUG
    1000 mg tablets twice daily

Study Details

Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or analogs, which rely on the gastrointestinal hormones that are part of the incretin system for the treatment of T2DM, provide a therapeutic alternative to common oral antihyperglycemic agents (eg, sulfonylureas, thiazolidinediones). Although GLP-1 analogs and DPP-4 inhibitor medications are effective, there are differences between these products, including method of administration (injectable versus oral). Previous studies have shown that patients prefer additional oral agents over injectable agents because of fear of injections and the desire to avoid them. Patient preference is both clinically and financially important, as it can have long-term implications in terms of patients' motivation and insight into their disease state and its treatment, which might have a direct impact on the patient's compliance and treatment adherence. The aim of the current study is to evaluate the proportion of T2DM patients preferring oral anti-diabetic treatment with vildagliptin + metformin versus an injectable anti-diabetic treatment with liraglutide after 4 weeks of treatment with each medication.

Key Dates

Start date
Jan 31, 2012
Status verified
Feb 2017
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Vildagliptin/Metformin followed by Liraglutide+Metformin
    In period I, Patients receiving vildagliptin will receive a stable dose of 50mg vildagliptin bid (twice daily) + 1000mg metformin bid for 12 weeks. In period II, patients will receive 0.6mg liraglutide od (once daily) + 1000mg metformin bid for the first week (week 13 - week 14) and increase the dose after 7 days up to 1.2mg liraglutide od/1000mg metformin bid.
  • Experimental: Liraglutide + Metformin followed by Vildagliptin/Metformin
    In period I, patients will receive 0.6mg liraglutide od (once daily) + 1000mg metformin bid (twice daily) for the first week (week 0 - week 1) and increase the dose after 7 days up to 1.2mg liraglutide od/1000mg metformin bid (week 2 -12). In period II, patients will receive a stable dose of 50mg vildagliptin bid (twice daily) + 1000mg metformin bid for next 12 weeks.

Primary Outcome Measure

Proportion of patients preferring each treatment regimen [ Time Frame: At week 24 ]

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