Clinical trial NCT01398592: Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes mellitus Type two
T2DM
vildagliptin
sitagliptin
FPG
DPP-4
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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...)

Primary outcomes:
measure: demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin
timeFrame: 14 days
Secondary outcomes:
measure: To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin
timeFrame: 14 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Celle
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kirchhain
country: Germany
facility: Novartis Investigative Site
city: Lehrte
country: Germany
facility: Novartis Investigative Site
city: Mülheim
country: Germany
facility: Novartis Investigative Site
city: Oberhausen
country: Germany
facility: Novartis Investigative Site
city: Osnabrück
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Kirchhain
name: Rüdiger Göke, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.