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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
Phase	Phase 4
Sponsor	Handok Pharmaceuticals Co., Ltd.
Responsible Party	Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier	NCT00975065
First Received	September 9, 2009
Last Updated	August 21, 2012
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	September 9, 2009
Last Updated Date	August 21, 2012
Start Date	August 2009
Estimated Primary Completion Date	April 2012
Current Primary Outcome Measures	Hemoglobin A1c at 24 weeks [Time Frame: 32weeks] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) vildagliptin 50 mg bid plus metformin 1500mg Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex) metformin 1500mg plus metformin 500mg or 1000mg
Study Arm (s)	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. 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	266
Estimated Completion Date	April 2012
Estimated Primary Completion Date	December 2011
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)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT00975065
Other Study ID Numbers	CLAF237AKR03T
Has Data Monitoring Committee	No
Information Provided By	Handok Pharmaceuticals Co., Ltd.
Study Sponsor	Handok Pharmaceuticals Co., Ltd.
Collaborators	Not Provided
Investigators	Principal Investigator: Sei Hyun Baik, professor Korea University Guro Hospital
Verification Date	August 2012

Locations[ + expand ][ + ]