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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 )
  Purpose
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 Intervention Phase
Diabetes Mellitus Type 2 Drug: Vildagliptin Drug: Sitagliptin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 187
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin
Experimental
Drug: Vildagliptin
50mg vildagliptin bid
Active Comparator: Sitagliptin
Active comparator (drug)
Drug: Sitagliptin
100mg sitagliptin po qd

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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…)

  Contacts and Locations
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


Locations
Germany
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Rüdiger Göke, MD Kirchhain
  More Information

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 Submitted: July 15, 2011
First Posted: July 20, 2011
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes mellitus Type two
T2DM
vildagliptin
sitagliptin
FPG
DPP-4

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