Long-term Safety Study of Vildagliptin in Patients With T... | NCT01159249

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

NCT01159249

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

245Actual

Phase

Phase 3

Conditions

Type 2 Diabetes

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

May 2012

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

Jun 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jul 7, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 9, 2010Estimated

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

May 20, 2015

Certification/Extension First Submitted that Passed QC Review

May 20, 2015

Certification/Extension First Posted Date

Jun 15, 2015Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Description Module

Brief Summary

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

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

245Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Open Met add-on vildagliptin	Other	Drug: Vildagliptin
Open TZD add-on vildagliptin	Other	Drug: Vildagliptin
Open α-GI add-on vildagliptin	Other	Drug: Vildagliptin
Glinides add-on vildagliptin	Other	Drug: Vildagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug		Glinides add-on vildagliptin Open Met add-on vildagliptin Open TZD add-on vildagliptin Open α-GI add-on vildagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure AEs, vital signs, laboratory evaluations		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
HBA1c		52 weeks
Fasting Plasma Glucose		52 weeks
Fasting Insulin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
Age in the 20 years or over inclusive
HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion Criteria:

Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
Significant heart diseases
Significant diabetic complications

Accepts Healthy Volunteers

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
Novartis Pharmaceuticals Corporation	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Hunabashi	Chiba	274-0805	Japan
Novartis Investigative Site

References Module

Citations

Not provided

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

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