Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy

Trial Profile

Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy

Completed
Phase of Trial: Phase IV

Latest Information Update: 28 Jan 2015

At a glance

  • Drugs Vildagliptin (Primary) ; Metformin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms OPTIMA
  • Sponsors Novartis
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 01 Oct 2012 Results published in Diabetes and Metabolism.
    • 03 May 2012 Actual patient number 36 added as reported by ClinicalTrials.gov.
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