Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications (PREFER)

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Liraglutide; Drug: Vildagliptin/ Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518101

2011-003818-16 (EudraCT Number)

CLMF237ADE03

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes
• Metformin monotherapy > 12 weeks
• Hemoglobin A1c (HbA1c) > 6.5 % and < 9.0 %
• Body mass Index (BMI) 19-35 (kg/m²)

Exclusion criteria

• acute diseases at randomization
• kidney diseases with creatinin > 120 µmol/l, glomerular filtration rate (GFR) <50 ml/min
• contraindication for Gliptins or glucagon-like-peptide-analogues according to the respective Summary of Product Characteristics (SmPC)
• previous use of dipeptidyl peptidase-4-inhibitors and GLP-1-mimetics

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Vildagliptin/Metformin followed by Liraglutide+Metformin

Experimental group

Description:

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.

Treatment:

Drug: Liraglutide

Drug: Vildagliptin/ Metformin

Drug: Metformin

Liraglutide + Metformin followed by Vildagliptin/Metformin

Experimental group

Description:

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.

Treatment:

Drug: Liraglutide

Drug: Vildagliptin/ Metformin

Drug: Metformin