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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Vildagliptin
Sitagliptin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Diabetes mellitus Type two, T2DM, vildagliptin, sitagliptin, FPG, DPP-4

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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…)

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vildagliptin

Sitagliptin

Arm Description

Experimental

Active comparator (drug)

Outcomes

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
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
Fasting Plasma Glucose on day 14 analyzed descriptively.

Full Information

First Posted
July 15, 2011
Last Updated
February 11, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01398592
Brief Title
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy
Acronym
FPG-VISIT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Diabetes mellitus Type two, T2DM, vildagliptin, sitagliptin, FPG, DPP-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Experimental
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
Active comparator (drug)
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Description
50mg vildagliptin bid
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
100mg sitagliptin po qd
Primary Outcome Measure Information:
Title
demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin
Description
Fasting Plasma Glucose measured on day 14.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin
Description
Fasting Plasma Glucose on day 14 analyzed descriptively.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rüdiger Göke, MD
Organizational Affiliation
Kirchhain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Bad Oeynhausen
ZIP/Postal Code
32549
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12347
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13597
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Novartis Investigative Site
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30165
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Novartis Investigative Site
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Novartis Investigative Site
City
Kirchhain
ZIP/Postal Code
35274
Country
Germany
Facility Name
Novartis Investigative Site
City
Lehrte
ZIP/Postal Code
31275
Country
Germany
Facility Name
Novartis Investigative Site
City
Mülheim
ZIP/Postal Code
45468
Country
Germany
Facility Name
Novartis Investigative Site
City
Oberhausen
ZIP/Postal Code
46049
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrück
ZIP/Postal Code
49080
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70378
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25457473
Citation
Goke R, Eschenbach P, Dutting 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.
Results Reference
derived

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Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

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