Submitted by: Melissa A. Alabado 2015-10-24 00:00:00 Last Updated by: Lawrence Allen Tria 2017-04-17 14:23:38 Export to PDF

INITIAL: A multinational, prospective, non-interventional 24-week study to assess effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug naive type 2 diabetes mellitus patients in a real-life setting

PHRR151102-001122

CLAF237A3421

Unspecified

A multinational, prospective, non-interventional 24-week study to assess effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug naive type 2 diabetes mellitus patients in a real-life setting

regional observational study on vildagliptin/metformin as initital combination therapy for diabetes mellitus patients

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-11-15 24 2017-11-15 0000-00-00

Pending

Not stated

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR CDRR-NCR-S-1
Institution Amount Region
Novartis Healthcare Philippines, Inc. N/A NCR
Name E-Mail Phone Number Postal Address
Carina Barlongo carina.barlongo@novartis.com +6323687777 2f ARCC bldg Gamboa cor Salcedo St.legaspi Village Makati
Name E-Mail Phone Number Postal Address
Helen Marie Florentino MD maria_helen.florentino@novartis.com +632368777 2f ARCC bldg Gamboa cor Salcedo St.legaspi Village Makati
Name Expertise Affiliation
Roberto C. Mirasol, MD Endocrinology St. Luke's Medical Center - Quezon City
Cecilia A. Jimeno, MD Endocrinology Philippine General Hospital
Mary Jane Gutierrez, MD Endocrinology St. Luke's Medical Center - Quezon City
Voltaire Cagampan, MD Internal Medicine Medicard Clinic, St. Luke's Medical Center
Vivian De Guzman, MD Internal Medicine Medicard Clinic, St. Luke's Medical Center
Leilani Mercado-Asis, MD Endocrinology Hospital Of The Infant Jesus
Catherine Emily Torres, MD Diabetology Torres Diabetes Clinic
Manolito Marciano, MD Internal Medicine MBS Specialty Clinic
Cynthia Dela Rea, MD Diabetology Valenzuela Citicare Medical Center
Criselda Villareal, MD Diabetology CMV Diabetes Clinic
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Medicard Clinic, St. Luke's Medical Center N/A
Medicard Clinic, St. Luke's Medical Center N/A
Hospital Of The Infant Jesus N/A
Torres Diabetes Clinic N/A
MBS Specialty Clinic N/A
Valenzuela Citicare Medical Center N/A
CMV Diabetes Clinic N/A

Type 2 DM

Primary objectives:

1.       To assess the effectiveness of vildagliptin/metformin dual therapy as initial combination in drug-naïve adult type 2 diabetes patients  over 24 weeks

Secondary objectives:

1.       To assess the proportion of patients achieving a glycemic target HbA1c level of <7%

2.       To assess the change from baseline in body weight over 24 weeks

3.       To assess overall safety and tolerability over 24 weeks

4.     To explore the change from baseline in HbA1c in relevant subpopulations (i.e. elderly, obese, patients with varying baseline HbA1c,) over 24 weeks.

Completed

  • Bangladesh
  • India
  • Philippines
  • Singapore
  • South Korea
  • Thailand

Clinical Trial

20150731145202

2015-09-24

None

Inclusion criteria

The study includes patients who meet the following criteria:

1.     Provide written informed consent before any data is collected

  1. >18 years of age
  2. Diagnosed with T2DM prior to study entry
  3. At least one documented HbA1c ≥7.5% measured within 4 weeks prior to study entry
  4. Prescribed treatment with vildagliptin/metformin initial dual therapy within 4 weeks prior to study entry and in compliance with the local prescribing information,  as either single pill combination or separate pill form
  5. Are T2DM drug-naïve, defined as either patients who 1) have never received an antidiabetic medication, or 2) have not taken any antidiabetic medication in the last three months before study entry AND never for longer than three consecutive months, with the exception of the medication of interest described above

Exclusion criteria

The study excludes patients who meet any of the following criteria:

1.     Contraindications to vildagliptin or metformin as per the local approved prescribing information

  1. Use of any investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer

 

Observational

Unspecified

Unspecified

Non-randomized

Open Label

Unspecified

Single Arm

The purpose of this non-interventional study is to provide effectiveness and safety evidence, observed from routine clinical practice, for initial combination therapy of vildagliptin/metformin in drug-naïve T2DM patients. The expectation is that, due to evolving standards of care and enhanced education of physicians and patients, this study will capture a large population of patients where initial combination therapy is utilized early for diabetes management. This study will add important clinical information to complement current and ongoing interventional studies.

Phase IV

100

128

increased country commitment

15 Nov 2015

Utilization Utilization Info
No records found.

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