| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups, HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory., Baseline, week 12 | Secondary: Percentage of Patients Meeting Responder Rates in HbA1c, Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c \< 7% , Criterion 3- Endpoint HbA1c \< 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (\> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements., Baseline, week 12|Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks, FPG was performed on a blood sample obtained and analyzed at a central laboratory., Baseline, week 12|Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia, Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is \< 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is \< 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2), 12 weeks|Number of Participants With Adverse Events, Serious Adverse Events and Death, The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, 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., 12 weeks
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| Locations: |
Novartis Investigative Site, Fukuoka-city, Fukuoka, 810-8798, Japan|Novartis Investigative Site, Fukuoka-city, Fukuoka, 815-0071, Japan|Novartis Investigative Site, Fukutsu-city, Fukuoka, 811-3217, Japan|Novartis Investigative Site, Kitakyushu-city, Fukuoka, 800-0295, Japan|Novartis Investigative Site, Koriyama-city, Fukushima, 963-8851, Japan|Novartis Investigative Site, Mito-city, Ibaraki, 311-4153, Japan|Novartis Investigative Site, Ibusuki-city, Kagoshima, 891-0401, Japan|Novartis Investigative Site, Yokohama-city, Kanagawa, 221-0802, Japan|Novartis Investigative Site, Kumamoto-city, Kumamoto, 861-8039, Japan|Novartis Investigative Site, Kumamoto-city, Kumamoto, 861-8520, Japan|Novartis Investigative Site, Yatsushiro-city, Kumamoto, 866-8533, Japan|Novartis Investigative Site, Kyoto-city, Kyoto, 615-0035, Japan|Novartis Investigative Site, Sendai-city, Miyagi, 980-0021, Japan|Novartis Investigative Site, Hirakata-City, Osaka, 573-0153, Japan|Novartis Investigative Site, Izumisano-city, Osaka, 598-8577, Japan|Novartis Investigative Site, Osaka-city, Osaka, 530-0001, Japan|Novartis Investigative Site, Osaka-city, Osaka, 534-0021, Japan|Novartis Investigative Site, Takatsuki-city, Osaka, 569-1096, Japan|Novartis Investigative Site, Ageo-city, Saitama, 362-8588, Japan|Novartis Investigative Site, Saitama-city, Saitama, 336-0963, Japan|Novartis Investigative Site, Sayama-city, Saitama, 350-1305, Japan|Novartis Investigative Site, Tokorozawa-city, Saitama, 359-1161, Japan|Novartis Investigative Site, Adachi-ku, Tokyo, 123-0845, Japan|Novartis Investigative Site, Chiyoda-ku, Tokyo, 101-0024, Japan|Novartis Investigative Site, Chuo-ku, Tokyo, 103-0027, Japan|Novartis Investigative Site, Chuo-ku, Tokyo, 103-0028, Japan|Novartis Investigative Site, Chuo-ku, Tokyo, 104-0061, Japan|Novartis Investigative Site, Nerima-ku, Tokyo, 177-0041, Japan|Novartis Investigative Site, Nerima-ku, Tokyo, 177-0051, Japan|Novartis Investigative Site, Ota-ku, Tokyo, 144-0051, Japan|Novartis Investigative Site, Suginami-ku, Tokyo, 166-0004, Japan
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