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NCT01398592 Clinical Trial

Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

Diabetes Mellitus Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01398592
Other study ID # CLMF237ADE02
Secondary ID 2011-000518-21
Status Completed
Phase Phase 4
First received July 15, 2011
Last updated February 11, 2013
Start date June 2011
Est. completion date June 2012

Study information
Verified date February 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 187
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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…)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin
50mg vildagliptin bid
• Sitagliptin
100mg sitagliptin po qd

Locations
Country Name City State
Germany Novartis Investigative Site Bad Oeynhausen
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Celle
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Kassel
Germany Novartis Investigative Site Kirchhain
Germany Novartis Investigative Site Lehrte
Germany Novartis Investigative Site Mülheim
Germany Novartis Investigative Site Oberhausen
Germany Novartis Investigative Site Osnabrück
Germany Novartis Investigative Site Potsdam
Germany Novartis Investigative Site Stuttgart

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 14 days No
Secondary 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. 14 days No
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