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

NCT ID: NCT00975065

Last Updated: 2012-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-04-30

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Galvus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galvus group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

vildagliptin 50 mg bid plus metformin 1500mg

Diabex group

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

Group Type: ACTIVE_COMPARATOR

metformin 1500mg plus metformin 500mg or 1000mg (Diabex)

Intervention Type: DRUG

metformin 1500mg plus metformin 500mg or 1000mg

Interventions

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

vildagliptin 50 mg bid plus metformin 1500mg

Intervention Type: DRUG

metformin 1500mg plus metformin 500mg or 1000mg (Diabex)

metformin 1500mg plus metformin 500mg or 1000mg

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Handok Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sei Hyun Baik, professor

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

Handok Pharmaceuticals

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

CLAF237AKR03T

Identifier Type: -

Identifier Source: org_study_id