Type 2 Diabetes
Conditions
Keywords
patient preference, vildagliptin, liraglutide
Brief summary
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.
Interventions
DRUGVildagliptin/ Metformin
Single pill combination of Vildagliptin/ Metformin (50/1000 mg).
DRUGLiraglutide
1.2 mg once daily by commercially available injection pens
DRUGMetformin
1000 mg tablets twice daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients preferring each treatment regimen | At week 24 | Individual patient preference will be assessed by a two-choice question. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients responding to subjective reasons of preference to each treatment | Week 12, week 24 | 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. |
| Number of patients with adverse event, serious adverse events and death | 24 weeks | 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. |
| Number of patients with treatment satisfaction for each treatment measured by Diabetes Treatment Satisfaction Questionnaire (TSQM-9) | week 12, Week 24 | 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). |
| Change From Baseline in Hemoglobin A1c (HbA1c) at week 12 and week 24 | From Baseline to 12 weeks and 24 weeks | HbA1c measurements will be performed at baseline, week 12 and week 24 visits. |
| Investigator preference and subjective reasons of preference to each treatment | Week 12, week 24 | 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. |
| Change from baseline in fasting plasma glucose at 12 weeks and 24 weeks | From Baseline to 12 weeks and 24 weeks | Blood glucose measurements will be performed at baseline, week 12 and week 24 visits. |
Countries
Germany
Outcome results
None listed