Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy (FPG-VISIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01398592
First received: July 15, 2011
Last updated: February 11, 2013
Last verified: February 2013

July 15, 2011
February 11, 2013
June 2011
June 2012   (final data collection date for primary outcome measure)
demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Fasting Plasma Glucose measured on day 14.
Same as current
Complete list of historical versions of study NCT01398592 on ClinicalTrials.gov Archive Site
To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Fasting Plasma Glucose on day 14 analyzed descriptively.
Same as current
Not Provided
Not Provided
 
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy
Cross-over Study to Assess the Difference in Fasting Plasma Glucose (FPG) Between Vildagliptin (Galvus®/Eucreas®) and Sitagliptin (Januvia®/Janumet®) After Two Weeks

This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Vildagliptin
    50mg vildagliptin bid
  • Drug: Sitagliptin
    100mg sitagliptin po qd
  • Experimental: Vildagliptin
    Experimental
    Intervention: Drug: Vildagliptin
  • Active Comparator: Sitagliptin
    Active comparator (drug)
    Intervention: Drug: Sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5%

Exclusion Criteria:

FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01398592
CLMF237ADE02, 2011-000518-21
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Rüdiger Göke, MD Kirchhain
Novartis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP