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

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ClinicalTrials.gov Identifier: NCT01398592
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Vildagliptin Drug: Sitagliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cross-over Study to Assess the Difference in Fasting Plasma Glucose (FPG) Between Vildagliptin (Galvus®/Eucreas®) and Sitagliptin (Januvia®/Janumet®) After Two Weeks
Study Start Date : June 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin
Drug: Vildagliptin
50mg vildagliptin bid
Active Comparator: Sitagliptin
Active comparator (drug)
Drug: Sitagliptin
100mg sitagliptin po qd

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398592

Novartis Investigative Site
Bad Oeynhausen, Germany, 32549
Novartis Investigative Site
Berlin, Germany, 12347
Novartis Investigative Site
Berlin, Germany, 13597
Novartis Investigative Site
Berlin, Germany, 14089
Novartis Investigative Site
Celle, Germany, 29221
Novartis Investigative Site
Hannover, Germany, 30165
Novartis Investigative Site
Hannover, Germany, 30167
Novartis Investigative Site
Kassel, Germany, 34117
Novartis Investigative Site
Kirchhain, Germany, 35274
Novartis Investigative Site
Lehrte, Germany, 31275
Novartis Investigative Site
Mülheim, Germany, 45468
Novartis Investigative Site
Oberhausen, Germany, 46049
Novartis Investigative Site
Osnabrück, Germany, 49080
Novartis Investigative Site
Potsdam, Germany, 14469
Novartis Investigative Site
Stuttgart, Germany, 70378
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Rüdiger Göke, MD Kirchhain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01398592     History of Changes
Other Study ID Numbers: CLMF237ADE02
2011-000518-21 ( EudraCT Number )
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes mellitus Type two

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action