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

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.

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex); Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)

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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Handok Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex); vildagliptin 50 mg bid plus metformin 1500mg
ACTIVE_COMPARATOR: 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	Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex); metformin 1500mg plus metformin 500mg or 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c at 24 weeks	32weeks

Secondary Outcome Measures

Outcome Measure	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	32weeks
Fasting Lipid profiles at 24 week	32weeks
Body weight at 24 week	32weeks
Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit	32weeks

Collaborators and Investigators

• Sponsor: Handok Inc.
• Investigators: Principal Investigator: Sei Hyun Baik, professor, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (ESTIMATE): September 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Galvus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: CLAF237AKR03T