Galvus on Met Phase 4 Study : Study to Evaluate the Effic... | NCT00975065

Studies
Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

NCT00975065

Sponsor

Handok Inc.

Status

Completed

Last Update Posted

Aug 23, 2012Estimated

Enrollment

266Actual

Phase

Phase 4

Conditions

Type 2 Diabetes Mellitus

Interventions

vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
metformin 1500mg plus metformin 500mg or 1000mg (Diabex)

Countries

South Korea

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

Official Title

A 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.

Status Module

Record Verification Date

Aug 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

Aug 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Apr 2012Actual

First Submitted Date

Sep 9, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

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

Aug 21, 2012

Last Update Posted Date

Aug 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

Detailed Description

The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability.
Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP.
Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary.
Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.

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

266Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Galvus group	Experimental	the combination of metformin plus Vildagliptin: vildagliptin 50 mg bid plus metformin 1500mg Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy.	Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
Diabex group	Active Comparator	metformin alone arm: metformin 1500mg plus metformin 500mg or 1000mg Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy	Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)	Drug	vildagliptin 50 mg bid plus metformin 1500mg	Galvus group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin A1c at 24 weeks		32weeks

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin A1c at 12 weeks		32weeks
Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week		32weeks
2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
Age of 18-80 years
Body Mass Index of 18-40 kg/m2

Exclusion Criteria:

Type 1 of diabetes
Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months
Congestive Heart Failure (III or NYHA class IV)
Liver disease such as cirrhosis or Chronic Active Hepatitis
History of Lacticacidemia
Use of any Oral Anti-diabetic Drug other than Metformin within the 2 months
Use of insulin before screening visit
ALT or AST >3 times the upper limit of Normal range
Creatinine >1.5 mg/dl
Other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Sei Hyun Baik, professor	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Handok Pharmaceuticals		Seoul	Seoul		South Korea

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000077597	Vildagliptin
C494814	BID protein, human
D008687	Metformin

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines