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 - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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

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 May 16, 2013