NCT01398592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

July 15, 2011

Last Update Submit

February 11, 2013

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes mellitus Type twoT2DMvildagliptinsitagliptinFPGDPP-4

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin

    14 days

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Experimental

Drug: Vildagliptin

Sitagliptin

ACTIVE COMPARATOR

Active comparator (drug)

Drug: Sitagliptin

Interventions

VildagliptinDRUG

50mg vildagliptin bid

Vildagliptin
SitagliptinDRUG

100mg sitagliptin po qd

Sitagliptin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes 18 to 85 years Metformin monotherapy \> 4 weeks HbA1c 6.5 - 9.5%

You may not qualify if:

  • FPG \> 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novartis Investigative Site

Bad Oeynhausen, 32549, Germany

Location

Novartis Investigative Site

Berlin, 12347, Germany

Location

Novartis Investigative Site

Berlin, 13597, Germany

Location

Novartis Investigative Site

Berlin, 14089, Germany

Location

Novartis Investigative Site

Celle, 29221, Germany

Location

Novartis Investigative Site

Hanover, 30165, Germany

Location

Novartis Investigative Site

Hanover, 30167, Germany

Location

Novartis Investigative Site

Kassel, 34117, Germany

Location

Novartis Investigative Site

Kirchhain, 35274, Germany

Location

Novartis Investigative Site

Lehrte, 31275, Germany

Location

Novartis Investigative Site

Mülheim, 45468, Germany

Location

Novartis Investigative Site

Oberhausen, 46049, Germany

Location

Novartis Investigative Site

Osnabrück, 49080, Germany

Location

Novartis Investigative Site

Potsdam, 14469, Germany

Location

Novartis Investigative Site

Stuttgart, 70378, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25457473DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriazolesAzolesPyrazines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Rüdiger Göke, MD

    Kirchhain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2011

First Posted

July 20, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

DE(15)