Vildagliptin Veresus Liraglutide - Patient Preference After Receiving Both Medications

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes
InterventionDrug: Vildagliptin/ Metformin
Drug: Liraglutide
Drug: Metformin
PhasePhase 4
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT01518101
First ReceivedJanuary 22, 2012
Last UpdatedAugust 16, 2013
Last verifiedAugust 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 22, 2012
Last Updated DateAugust 16, 2013
Start DateJanuary 2012
Estimated Primary Completion DateOctober 2012
Current Primary Outcome MeasuresProportion 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.
Current 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.

Descriptive Information[ + expand ][ + ]

Brief TitleVildagliptin Veresus Liraglutide - Patient Preference After Receiving Both Medications
Official TitleA 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.
Brief 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, 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: 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
Study Arm (s)
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment62
Estimated Completion DateOctober 2012
Estimated Primary Completion DateOctober 2012
Eligibility 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.
GenderBoth
Ages40 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesGermany

Administrative Information[ + expand ][ + ]

NCT Number NCT01518101
Other Study ID NumbersCLMF237ADE03
Has Data Monitoring CommitteeNot Provided
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification DateAugust 2013

Locations[ + expand ][ + ]

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