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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975065
• Other study ID #: CLAF237AKR03T
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2009
• Last updated: August 21, 2012
• Start date: August 2009
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
vildagliptin 50 mg bid plus metformin 1500mg
• metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
metformin 1500mg plus metformin 500mg or 1000mg

Locations

Country	Name	City	State
Korea, Republic of	Handok Pharmaceuticals	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c at 24 weeks		32weeks	No
Secondary	Hemoglobin A1c at 12 weeks		32weeks	No
Secondary	Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week		32weeks	No
Secondary	2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week		32weeks	No
Secondary	Fasting Lipid profiles at 24 week		32weeks	No
Secondary	Body weight at 24 week		32weeks	Yes
Secondary	Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit		32weeks	Yes