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. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Vildagliptin/ Metformin Drug: Liraglutide Drug: Metformin |
Phase | Phase 4 |
Sponsor | Novartis Pharmaceuticals |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT01518101 |
First Received | January 22, 2012 |
Last Updated | August 16, 2013 |
Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 22, 2012 |
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Last Updated Date | August 16, 2013 |
Start Date | January 2012 |
Estimated Primary Completion Date | October 2012 |
Current Primary Outcome Measures | Proportion 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Vildagliptin Veresus Liraglutide - Patient Preference After Receiving Both Medications |
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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. |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 62 |
Estimated Completion Date | October 2012 |
Estimated Primary Completion Date | October 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. |
Gender | Both |
Ages | 40 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01518101 |
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Other Study ID Numbers | CLMF237ADE03 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Novartis |
Study Sponsor | Novartis Pharmaceuticals |
Collaborators | Not Provided |
Investigators | Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals |
Verification Date | August 2013 |
Locations[ + expand ][ + ]
Novartis Investigative Site | Berlin, Germany, 13055 |
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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 |