Vildagliptin Compared to Gliclazide in Combination With M... | NCT00102466

Studies
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

NCT00102466

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

1,007Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptin
Gliclazide
Metformin

Countries

Germany
Switzerland

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 2017

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

Jan 2005

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jan 29, 2005

First Submission Date that Met QC Criteria

Jan 28, 2005

First Posted Date

Jan 31, 2005Estimated

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

Jan 2, 2013

Certification/Extension First Submitted that Passed QC Review

Jan 2, 2013

Certification/Extension First Posted Date

Jan 4, 2013Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Description Module

Brief Summary

This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

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

1,007Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vildagliptin	Experimental		Drug: vildagliptin Drug: Metformin
Gliclazide	Active Comparator		Drug: Gliclazide Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vildagliptin	Drug		Vildagliptin
Gliclazide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c at 52 weeks		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse event profile after 52 weeks of treatment		52 weeks
Change from baseline in fasting plasma glucose at 52 weeks		52 weeks
Patients with endpoint HbA1c <7% at 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

On a stable dose of metformin as defined by the protocol
Blood glucose criteria must be met
Body mass index (BMI) in the range 22-45

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

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
Investigative Centers		Nuremberg			Germany
Novartis Pharmaceuticals

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