A Sub-study to LMF237A2302 to Assess the Effect of 24 Wee... | NCT00468039

Studies
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

NCT00468039

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

94Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptin + metformin

Countries

United States

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

Official Title

A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control

Status Module

Record Verification Date

Aug 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

Mar 6, 2007Actual

Primary Completion Date

Jun 6, 2008Actual

Completion Date

Jun 6, 2008Actual

First Submitted Date

Apr 27, 2007

First Submission Date that Met QC Criteria

Apr 27, 2007

First Posted Date

May 1, 2007Estimated

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

Aug 20, 2020

Certification/Extension First Submitted that Passed QC Review

Aug 20, 2020

Certification/Extension First Posted Date

Aug 28, 2020Actual

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 19, 2020Actual

Description Module

Brief Summary

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

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

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vildagliptin + metformin	Experimental		Drug: vildagliptin + metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vildagliptin + metformin	Drug		vildagliptin + metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glycosylated hemoglobin (HbA1c)at Baseline and week 24		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
HbA1c at Baseline and week 12		12 weeks
Fasting plasma glucose test (FPG) at Baseline and week 24		24 weeks
Weight at baseline and week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
Body mass index 22-40 kg/meter squared
HbA1c > 11% and/or FPG >270 mg/dL

Exclusion Criteria:

Pregnant or lactating female
History of type 1 diabetes
Evidence of significant diabetic complications
Treatment with insulin or any other oral antidiabetic agent

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

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
Diabetes and Glandular Disease Research Associates		San Antonio	Texas	78229	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19320662	Result	Bosi E, Dotta F, Jia Y, Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 May;11(5):506-15. doi: 10.1111/j.1463-1326.2009.01040.x. Epub 2009 Mar 23.

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