Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

Type 2 Diabetes Clinical Trial

— PREFER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518101
• Other study ID #: CLMF237ADE03
• Secondary ID: 2011-003818-16
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2012
• Last updated: February 23, 2017
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Vildagliptin/ Metformin
Single pill combination of Vildagliptin/ Metformin (50/1000 mg).
• Liraglutide
1.2 mg once daily by commercially available injection pens
• Metformin
1000 mg tablets twice daily

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Falkensee
Germany	Novartis Investigative Site	Meissen
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Saarlouis
Germany	Novartis Investigative Site	Völlkingen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lüdemann J, Dütting 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 Ad — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results for CLMF237ADE03 from the Novartis Clinical Trials website