Efficacy and Safety of Combination Therapy of Vildaglipti... | NCT01196546

Studies
Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)

NCT01196546

Sponsor

Novartis

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

161Actual

Phase

Phase 4

Conditions

Type 2 Diabetes Mellitus

Interventions

vildagliptin/metformin

Countries

Thailand

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

Feb 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 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Aug 28, 2010

First Submission Date that Met QC Criteria

Sep 4, 2010

First Posted Date

Sep 8, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2017

Last Update Posted Date

Aug 1, 2017Actual

Description Module

Brief Summary

This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Label	Type	Description	Intervention Names
Vildagliptin/metformin	Experimental		Drug: vildagliptin/metformin

Name	Type	Description	Arm Group Labels	Other Names
vildagliptin/metformin	Drug		Vildagliptin/metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c reduction		24 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients who achieve target of HbA1c<6.5% at the end of study		24 weeks after treatment
To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
The patient is required to have HbA1c 6.5-11.0%
BMI in the range of 22-48 kg/m2

Exclusion Criteria:

Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)
Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
Congestive heart failure requiring pharmacologic treatment
Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
Liver disease such as cirrhosis or chronic active hepatitis

Accepts Healthy Volunteers

Yes

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BMA Medical College and Vajira Hospital		Bangkok			Thailand
King Chulalongkorn Memorial Hospital

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
D008687	Metformin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided