Type 2 Diabetes
Conditions
Keywords
type 2 diabetes;, vildagliptin;, metformin;
Brief summary
This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.
Interventions
DRUGMetformin
500 mg twice daily
DRUGvildagliptin
Vildagliptin 50 mg twice daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chinese T2D patients who are inadequate controlled (6.5 %\< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),
Exclusion criteria
* Type 1 diabetes and secondary diabetes * Acute metabolic diabetic complications within the past 3 months. * Acute infections which may influence glucose level. * Evidence of significant chronic diabetic complications, * Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis, * FPG \> 270 mg/dl (15 mmol/l) * Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin | baseline, 24 weeks | The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% | baseline and 24 weeks | The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% of two treatment arms in the overall population and in pre defined sub groups. |
| Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events | baseline and 24 weeks | The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% without adverse GI events of two treatment arms in the overall population and in pre defined sub groups. |
| Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups | baseline and 24 weeks | The changes from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analyzed in pre-defined patient subgroups based on Body Mass Index(BMI) ( \<24, ≥ 24) and age (\<60 y and ≥ 60 y) |
| Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample | baseline, 24 weeks | Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients. |
| Number of patients with adverse events, serious adverse events and death | up to 24 weeks | Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. |
| Mean change from baseline in fasting plasma glucose (FPG) | baseline, 24 weeks | Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups. |
Countries
China
Outcome results
None listed