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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
183
vildagliptin 50 mg twice daily
Matching Placebo of vildagliptin 50 mg twice daily
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups
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.
Time frame: Baseline to 12 weeks
Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses
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.
Time frame: Baseline to 12 weeks
Change from baseline in Fasting plasma glucose (FPG) at 12 weeks
FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.
Time frame: Baseline to 12 weeks
Percentage of patients meeting Responder rates in HbA1c
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%
Time frame: 12 weeks
Number of patients with adverse events (including hypoglycemia), serious adverse events and death
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.
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Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Kurume, Fukuoka, Japan
Novartis Investigative Site
Ohkawa-city, Fukuoka, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Takatsuki, Osaka, Japan
...and 10 more locations
Time frame: 12 weeks