| Trial ID: | L3537 |
| Source ID: | NCT01518101
|
| Associated Drug: |
Vildagliptin/ Metformin
|
| Title: |
Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications
|
| Acronym: |
PREFER
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Vildagliptin/ Metformin|DRUG: Liraglutide|DRUG: Metformin
|
| Outcome Measures: |
Primary: Proportion of patients preferring each treatment regimen, Individual patient preference will be assessed by a two-choice question., At week 24 | Secondary: 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)., week 12, Week 24|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., Week 12, week 24|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., 24 weeks|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., From Baseline to 12 weeks and 24 weeks|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., From Baseline to 12 weeks and 24 weeks|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., Week 12, week 24
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
62
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-01
|
| Completion Date: |
2012-10
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-27
|
| Locations: |
Novartis Investigative Site, Berlin, 10115, Germany|Novartis Investigative Site, Berlin, 13055, Germany|Novartis Investigative Site, Dortmund, 44137, Germany|Novartis Investigative Site, Falkensee, 14612, Germany|Novartis Investigative Site, Meissen, 01662, Germany|Novartis Investigative Site, Neunkirchen, 57290, Germany|Novartis Investigative Site, Saarlouis, 66740, Germany|Novartis Investigative Site, Völlkingen, 66333, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01518101
|
