Diabetes Mellitus, Type 2
Conditions
Keywords
Vildagliptin, Type 2 diabetes, HbA1c, Fasting plasma glucose
Brief summary
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.
Interventions
DRUGVildagliptin
vildagliptin 50 mg twice daily
DRUGPlacebo
Matching Placebo of vildagliptin 50 mg twice daily
Sponsors
Novartis Pharmaceuticals
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy. * HbA1c in the range of 7.0-10.0% * Body mass index in the range 20-35 kg/m2
Exclusion criteria
* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * Significant heart diseases Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups | Baseline to 12 weeks | HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses | Baseline to 12 weeks | HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory. |
| Change from baseline in Fasting plasma glucose (FPG) at 12 weeks | Baseline to 12 weeks | FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory. |
| Percentage of patients meeting Responder rates in HbA1c | 12 weeks | Responder rates will be categorized by predefined HbA1c value at 12 weeks : * Endpoint HbA1c ≤ 6.5% * Endpoint HbA1c ≤ 7% * Endpoint HbA1c ≤ 7% in patients with baseline HbA1c ≤ 8% |
| Number of patients with adverse events (including hypoglycemia), serious adverse events and death | 12 weeks | The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. 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. |
Countries
Japan
Outcome results
None listed