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Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

NCT ID: NCT01398592

Last Updated: 2013-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vildagliptin

Experimental

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

50mg vildagliptin bid

Sitagliptin

Active comparator (drug)

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

100mg sitagliptin po qd

Interventions

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Vildagliptin

50mg vildagliptin bid

Intervention Type DRUG

Sitagliptin

100mg sitagliptin po qd

Intervention Type DRUG

Eligibility Criteria

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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…)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Rüdiger Göke, MD

Role: PRINCIPAL_INVESTIGATOR

Kirchhain

Locations

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Novartis Investigative Site

Bad Oeynhausen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Celle, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis Investigative Site

Kirchhain, , Germany

Site Status

Novartis Investigative Site

Lehrte, , Germany

Site Status

Novartis Investigative Site

Mülheim, , Germany

Site Status

Novartis Investigative Site

Oberhausen, , Germany

Site Status

Novartis Investigative Site

Osnabrück, , Germany

Site Status

Novartis Investigative Site

Potsdam, , Germany

Site Status

Novartis Investigative Site

Stuttgart, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25457473 (View on PubMed)

Other Identifiers

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2011-000518-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLMF237ADE02

Identifier Type: -

Identifier Source: org_study_id

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