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

February 23, 2017 updated by: Novartis Pharmaceuticals

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Novartis Investigative Site
      • Berlin, Germany, 13055
        • 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
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients preferring each treatment regimen
Time Frame: At week 24
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)
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).
week 12, Week 24
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.
Week 12, week 24
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.
24 weeks
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.
From Baseline to 12 weeks and 24 weeks
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.
From Baseline to 12 weeks and 24 weeks
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.
Week 12, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

January 22, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLMF237ADE03
  • 2011-003818-16 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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