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Completed

NCT Number: NCT01518101

Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

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.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Völlkingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Proportion of patients preferring each treatment regimen

    Time frame: At week 24

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

Secondary outcomes

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

    Time frame: 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).

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: From Baseline to 12 weeks and 24 weeks

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

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

    Time frame: From Baseline to 12 weeks and 24 weeks

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

  6. Investigator preference and subjective reasons of preference to each treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Acronym: PREFER

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2012
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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