Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Cross-over Study to Evaluate Patient Preferences for Eucreas® Versus Victoza® as add-on to Metformin in Type 2 Diabetes Mellitus Patients Who Did Not Have Adequate Glycaemic Control With Metformin.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Vildagliptin/ Metformin
* Drug: Liraglutide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin/Metformin followed by Liraglutide+Metformin<br>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. | Drug: Vildagliptin/ Metformin<br>* Single pill combination of Vildagliptin/ Metformin (50/1000 mg).<br>Drug: Liraglutide<br>* 1.2 mg once daily by commercially available injection pens<br>Drug: Metformin<br>* 1000 mg tablets twice daily<br>|
| Experimental: Liraglutide + Metformin followed by Vildagliptin/Metformin<br>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. | Drug: Vildagliptin/ Metformin<br>* Single pill combination of Vildagliptin/ Metformin (50/1000 mg).<br>Drug: Liraglutide<br>* 1.2 mg once daily by commercially available injection pens<br>Drug: Metformin<br>* 1000 mg tablets twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients preferring each treatment regimen | Individual patient preference will be assessed by a two-choice question. | At week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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. | Week 12, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient preference, vildagliptin, liraglutide