Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00099866

First received: December 21, 2004

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2004

Last Updated Date

May 4, 2012

Start Date ^ICMJE

January 2004

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c at 52 weeks

Original Primary Outcome Measures ^ICMJE

Blood glucose levels

Change History

Complete list of historical versions of study NCT00099866 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose at 52 weeks
Adverse event profile after 52 weeks of treatment
Change from baseline in body weight at 52 weeks
Change from baseline in fasting lipids at 52 weeks
Change from baseline in HOMA B at 52 weeks

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Official Title ^ICMJE

Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Brief Summary

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: vildagliptin
Other Name: LAF237A
Drug: Metformin Comparator

Study Arm (s)

Experimental: Vildagliptin
Intervention: Drug: vildagliptin
Active Comparator: Metformin
Intervention: Drug: Metformin Comparator

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

570

Completion Date

August 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Not currently on durg therapy for type 2 diabetes
Body mass index (BMI) in the range 22-45
Blood glucose criteria must be met

Exclusion Criteria:

Type 1 diabetes
Pregnancy or lactation
Evidence of serious diabetic complications
Evidence of serious cardiovascular conditions
Laboratory value abnormalities as defined by the protocol
Other protocol-defined exclusion criteria may apply

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00099866

Other Study ID Numbers ^ICMJE

CLAF237A2309

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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