Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00101673

First received: January 12, 2005

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2005

Last Updated Date

May 4, 2012

Start Date ^ICMJE

March 2004

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c at 12 weeks

Original Primary Outcome Measures ^ICMJE

Blood glucose levels

Change History

Complete list of historical versions of study NCT00101673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse event profile after 12 weeks of treatment
Patients with reduction in HbA1c >/= 0.7% after 12 weeks
Change from baseline in fasting plasma glucose at 12 weeks
Change from baseline in HOMA-B at 12 weeks
Change from baseline in body weight at 12 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 in Patients With Type 2 Diabetes With HbA1c 9-11%

Official Title ^ICMJE

Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Brief Summary

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

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
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: vildagliptin

Study Arm (s)

Not Provided

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

251

Completion Date

June 2005

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy or lactation
Type 1 diabetes
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 and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00101673

Other Study ID Numbers ^ICMJE

CLAF237A2329

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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