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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398592
First Posted: July 20, 2011
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
July 15, 2011
July 20, 2011
February 12, 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 ]
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 ]
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: None (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
Göke R, Eschenbach P, Dütting ED. Efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose: Results of a randomized controlled trial. Diabetes Metab. 2015 Jun;41(3):244-7. doi: 10.1016/j.diabet.2014.07.004. Epub 2014 Nov 11.

*   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…)

Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01398592
CLMF237ADE02
2011-000518-21 ( EudraCT Number )
Not Provided
Not Provided
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