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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00975065
First received: September 9, 2009
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Hemoglobin A1c at 24 weeks [ Time Frame: 32weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c at 12 weeks [ Time Frame: 32weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week [ Time Frame: 32weeks ] [ Designated as safety issue: No ]
  • 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week [ Time Frame: 32weeks ] [ Designated as safety issue: No ]
  • Fasting Lipid profiles at 24 week [ Time Frame: 32weeks ] [ Designated as safety issue: No ]
  • Body weight at 24 week [ Time Frame: 32weeks ] [ Designated as safety issue: Yes ]
  • Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit [ Time Frame: 32weeks ] [ Designated as safety issue: Yes ]

Enrollment: 266
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975065

Locations
Korea, Republic of
Handok Pharmaceuticals
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Sei Hyun Baik, professor Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT00975065     History of Changes
Other Study ID Numbers: CLAF237AKR03T
Study First Received: September 9, 2009
Last Updated: August 21, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
Galvus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014