Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, vildagliptin, metformin
Brief summary
This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.
Interventions
DRUGvildagliptin/metformin
Sponsors
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months * The patient is required to have HbA1c 6.5-11.0% * BMI in the range of 22-48 kg/m2
Exclusion criteria
* Severe or uncontrolled Type 2 diabetes mellitus (HbA1c\> 11.0%) * Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months * Congestive heart failure requiring pharmacologic treatment * Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention * Liver disease such as cirrhosis or chronic active hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c reduction | 24 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve target of HbA1c<6.5% at the end of study | 24 weeks after treatment |
| To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles | 24 weeks after treatment |
Countries
Thailand
Outcome results
None listed