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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

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ClinicalTrials.gov Identifier: NCT00975065
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : August 23, 2012
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment 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

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  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Hemoglobin A1c at 24 weeks [ Time Frame: 32weeks ]

Secondary Outcome Measures :
  1. Hemoglobin A1c at 12 weeks [ Time Frame: 32weeks ]
  2. Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week [ Time Frame: 32weeks ]
  3. 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week [ Time Frame: 32weeks ]
  4. Fasting Lipid profiles at 24 week [ Time Frame: 32weeks ]
  5. Body weight at 24 week [ Time Frame: 32weeks ]
  6. Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit [ Time Frame: 32weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT00975065     History of Changes
Other Study ID Numbers: CLAF237AKR03T
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action