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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01518101
First received: January 22, 2012
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Vildagliptin/ Metformin
Drug: Liraglutide
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients preferring each treatment regimen [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
    Individual patient preference will be assessed by a two-choice question.


Secondary Outcome Measures:
  • Number of patients with treatment satisfaction for each treatment measured by Diabetes Treatment Satisfaction Questionnaire (TSQM-9) [ Time Frame: week 12, Week 24 ] [ Designated as safety issue: No ]
    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).

  • Number of patients responding to subjective reasons of preference to each treatment [ Time Frame: Week 12, week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Change from baseline in fasting plasma glucose at 12 weeks and 24 weeks [ Time Frame: From Baseline to 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Blood glucose measurements will be performed at baseline, week 12 and week 24 visits.

  • Change From Baseline in Hemoglobin A1c (HbA1c) at week 12 and week 24 [ Time Frame: From Baseline to 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    HbA1c measurements will be performed at baseline, week 12 and week 24 visits.

  • Investigator preference and subjective reasons of preference to each treatment [ Time Frame: Week 12, week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin/Metformin followed by Liraglutide+Metformin
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
Single pill combination of Vildagliptin/ Metformin (50/1000 mg).
Drug: Liraglutide
1.2 mg once daily by commercially available injection pens
Drug: Metformin
1000 mg tablets twice daily
Experimental: Liraglutide + Metformin followed by Vildagliptin/Metformin
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
Single pill combination of Vildagliptin/ Metformin (50/1000 mg).
Drug: Liraglutide
1.2 mg once daily by commercially available injection pens
Drug: Metformin
1000 mg tablets twice daily

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518101

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 13055
Novartis Investigative Site
Berlin, Germany, 10115
Novartis Investigative Site
Dortmund, Germany, 44137
Novartis Investigative Site
Falkensee, Germany, 14612
Novartis Investigative Site
Meissen, Germany, 01662
Novartis Investigative Site
Neunkirchen, Germany, 57290
Novartis Investigative Site
Saarlouis, Germany, 66740
Novartis Investigative Site
Völlkingen, Germany, 66333
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01518101     History of Changes
Other Study ID Numbers: CLMF237ADE03, 2011-003818-16
Study First Received: January 22, 2012
Last Updated: August 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
patient preference
vildagliptin
liraglutide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014