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Type 2 DiabetesPhase 4PREFERNCT01518101

Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

A Phase 4 study testing Vildagliptin/ Metformin, Liraglutide and Metformin in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 8 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Vildagliptin/ Metformin, Liraglutide and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
8 sitesGermany
Study dates
Jan 2012to Oct 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Novartis Investigative Site

    Berlin, 10115

  • Novartis Investigative Site

    Berlin, 13055

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Falkensee, 14612

  • Novartis Investigative Site

    Meissen, 01662

  • Novartis Investigative Site

    Neunkirchen, 57290

  • Novartis Investigative Site

    Saarlouis, 66740

  • Novartis Investigative Site

    Völlkingen, Germany, 66333

Other trials in Germany

About this study

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.

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.

Conditions
Type 2 Diabetes
Being tested
Vildagliptin/ Metformin, Liraglutide, Metformin
Keywords
patient preference, vildagliptin, liraglutide
Medical subject headings
Diabetes Mellitus, Type 2, Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vildagliptin/ MetforminDrug

    Single pill combination of Vildagliptin/ Metformin (50/1000 mg).

  • LiraglutideDrug

    1.2 mg once daily by commercially available injection pens

  • MetforminDrug

    1000 mg tablets twice daily

Study groups in NCT01518101
Study groupRoleWhat they receive
Vildagliptin/Metformin followed by Liraglutide+MetforminExperimentalIn 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.
Receives: Drug: Vildagliptin/ Metformin; Drug: Liraglutide; Drug: Metformin
Liraglutide + Metformin followed by Vildagliptin/MetforminExperimentalIn 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.
Receives: Drug: Vildagliptin/ Metformin; Drug: Liraglutide; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients preferring each treatment regimen

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

    Measured: At week 24

Secondary outcomes (6)

  1. 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).

    Measured: week 12, Week 24

  2. 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.

    Measured: Week 12, week 24

  3. 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.

    Measured: 24 weeks

  4. 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.

    Measured: From Baseline to 12 weeks and 24 weeks

  5. 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.

    Measured: From Baseline to 12 weeks and 24 weeks

  6. 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.

    Measured: Week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01518101
Sponsor's protocol ID
CLMF237ADE03
Other IDs
2011-003818-16
Acronym
PREFER
Status last verified
Feb 2017
First submitted
22 Jan 2012
Last updated
27 Feb 2017
Results posted
No

Publications

  • Ludemann J, Dutting ED, Dworak M. Patient preference and tolerability of a DPP-4 inhibitor versus a GLP-1 analog in patients with type 2 diabetes mellitus inadequately controlled with metformin: a 24-week, randomized, multicenter, crossover study. Ther Adv Endocrinol Metab. 2015 Aug;6(4):141-8. doi: 10.1177/2042018815595584.

    PubMed 26301063

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vildagliptin/ Metformin, Liraglutide and Metformin in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 8 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients preferring each treatment regimen (time frame: At week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01518101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.

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