Type 2 Diabetes Mellitus
Conditions
Keywords
Galvus
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.
Interventions
DRUGvildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)
vildagliptin 50 mg bid plus metformin 1500mg
DRUGmetformin 1500mg plus metformin 500mg or 1000mg (Diabex)
metformin 1500mg plus metformin 500mg or 1000mg
Sponsors
Handok Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c at 24 weeks | 32weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week | 32weeks |
| 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week | 32weeks |
| Hemoglobin A1c at 12 weeks | 32weeks |
| Body weight at 24 week | 32weeks |
| Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit | 32weeks |
| Fasting Lipid profiles at 24 week | 32weeks |
Countries
South Korea
Outcome results
None listed