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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
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Novartis:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398592

Locations
Germany
Novartis Investigative Site
Bad Oeynhausen, Germany, 32549
Novartis Investigative Site
Berlin, Germany, 14089
Novartis Investigative Site
Berlin, Germany, 13597
Novartis Investigative Site
Berlin, Germany, 12347
Novartis Investigative Site
Celle, Germany, 29221
Novartis Investigative Site
Hannover, Germany, 30167
Novartis Investigative Site
Hannover, Germany, 30165
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01398592     History of Changes
Other Study ID Numbers: CLMF237ADE02, 2011-000518-21
Study First Received: July 15, 2011
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
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
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013