Long-Term Safety Study of Vildagliptin in Patients With T... | NCT00325429

Studies
Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

NCT00325429

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 7, 2009Estimated

Enrollment

150

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 10, 2006

First Submission Date that Met QC Criteria

May 10, 2006

First Posted Date

May 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2009

Last Update Posted Date

Jan 7, 2009Estimated

Description Module

Brief Summary

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events profile after 52 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to endpoint on HbA1c at 52 weeks
Change from baseline to endpoint on fasting plasma glucose at 52 weeks
Change from baseline to endpoint in HOMA B at 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of type 2 diabetes
Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels
Outpatients

Exclusion Criteria:

Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
Significant cardiovascular complications as defined by the protocol
Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077597	Vildagliptin

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided