Clinical trial NCT00975065: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Galvus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Hemoglobin A1c at 24 weeks
timeFrame: 32weeks
Secondary outcomes:
measure: Hemoglobin A1c at 12 weeks
timeFrame: 32weeks
measure: Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week
timeFrame: 32weeks
measure: 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week
timeFrame: 32weeks
measure: Fasting Lipid profiles at 24 week
timeFrame: 32weeks
measure: Body weight at 24 week
timeFrame: 32weeks
measure: Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit
timeFrame: 32weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Handok Pharmaceuticals
Study officials:
affiliation: Korea University Guro Hospital
name: Sei Hyun Baik, professor
role: PRINCIPAL_INVESTIGATOR
References: