Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

NCT ID: NCT01426802

Last Updated: 2017-02-27

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-04-30

Brief Summary

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The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vildagliptin 50 bid

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

Drug 50mg vildagliptin bid

Interventions

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vildagliptin

Drug 50mg vildagliptin bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who sign the informed consent
* HbA1c in the range of \> 7 to ≤10.5% at Visit 1
* Ability to comply with all study requirements

Exclusion Criteria

* Pregnant or lactating women
* Serious cardiovascular disorders
* Liver/renal disease or dysfunction
* Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
* Laboratories values abnormalities as defined by the protocol
Minimum Eligible Age

18 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

Locations

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Investigative site

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CLAF237AEG01

Identifier Type: -

Identifier Source: org_study_id

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