Efficacy and Safety of Vildagliptin Compared to Metformin... | NCT00383578

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

NCT00383578

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

335Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin 100 mg qd
Metformin 1500 mg daily

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

Jan 2013

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

Sep 2006

Primary Completion Date

May 2008Actual

Completion Date

Not provided

First Submitted Date

Sep 29, 2006

First Submission Date that Met QC Criteria

Sep 29, 2006

First Posted Date

Oct 3, 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

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 designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive 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

335Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vildagliptin	Experimental		Drug: Vildagliptin 100 mg qd
Metformin	Active Comparator		Drug: Metformin 1500 mg daily

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin 100 mg qd	Drug		Vildagliptin
Metformin 1500 mg daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c		after 24 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Adverse event profile		after 24 weeks of treatment
Gastrointestinal tolerability		after 24 weeks of treatment
Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age from 65 years to the upper age limit recommended by local prescribing information for metformin
Drug naive patients with type 2 diabetes.
Body mass index (BMI) in the range of 22-40 kg/m2.
HbA1c in the range of 7 to 9% inclusive
FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

A history of type 1 diabetes
Evidence of significant diabetic complications
Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older 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