Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

Novartis Pharmaceuticals62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (8)

Novartis Investigative Site

Völlkingen, Germany, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Dortmund, Germany

Novartis Investigative Site

Falkensee, Germany

Novartis Investigative Site

Meissen, Germany

Novartis Investigative Site

Neunkirchen, Germany

Novartis Investigative Site

Saarlouis, Germany

Outcomes

Primary Outcomes

Proportion of patients preferring each treatment regimen

Individual patient preference will be assessed by a two-choice question.

Time frame: At week 24

Secondary Outcomes

Number of patients with treatment satisfaction for each treatment measured by Diabetes Treatment Satisfaction Questionnaire (TSQM-9)

The TSQM -9 is a psychometrically measure of the major dimensions of patients' satisfaction with medication. It provides scores on 3 scales: effectiveness (3 items), convenience (3 items) and global satisfaction (3 items).

Time frame: week 12, Week 24

Number of patients responding to subjective reasons of preference to each treatment

Individual patient preference will be assessed by a two-choice question. Patients will also be asked to specify the reason for preference. A specific questionnaire for the preference reasons will be provided.

Time frame: Week 12, week 24

Number of patients with adverse event, serious adverse events and death

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Time frame: 24 weeks

Change from baseline in fasting plasma glucose at 12 weeks and 24 weeks

Blood glucose measurements will be performed at baseline, week 12 and week 24 visits.

Time frame: From Baseline to 12 weeks and 24 weeks

Change From Baseline in Hemoglobin A1c (HbA1c) at week 12 and week 24

HbA1c measurements will be performed at baseline, week 12 and week 24 visits.

Time frame: From Baseline to 12 weeks and 24 weeks

Investigator preference and subjective reasons of preference to each treatment

Investigator preference will be assessed by a two-choice question. Investigator will also be asked to specify the reason for preference. A specific questionnaire for the preference reasons will be provided.

Time frame: Week 12, week 24