Outcome Measures: |
Primary: Proportion of Participants With Adverse Events, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events, Long-term treatment up to 52 weeks|Proportion of Participants With Serious Adverse Events, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events, Long-term treatment up to 52 weeks|Proportion of Participants With At Least One Episode of Hypoglycemia, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia, Long-term treatment up to 52 weeks|Mean Change in Hematocrit, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit, Baseline to Week 52|Mean Change in Alanine Aminotransferase (ALT), To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase, Baseline to Week 52|Mean Change in Aspartate Aminotransferase (AST), To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase, Baseline to Week 52|Mean Change in Blood Urea Nitrogen (BUN), To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen, Baseline to Week 52|Mean Change in Magnesium, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L), Baseline to Week 52|Mean Change in Serum Uric Acid, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid, Baseline to Week 52|Mean Change in Seated Heart Rate, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse, Baseline to Week 52|Mean Change in Seated Diastolic Blood Pressure, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure, Baseline to Week 52|Mean Change in Seated Systolic Blood Pressure, To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure, Baseline to Week 52 | Other: Mean Change in HbA1c Levels, To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c, Baseline to Week 52|Mean Change in Body Weight, To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight, Baseline to Week 52
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Locations: |
Research Site, Nagoya, Aichi, Japan|Research Site, Owariasahi, Aichi, Japan|Research Site, Toyohashi, Aichi, Japan|Research Site, Hirosaki, Aomori, Japan|Research Site, Niihama, Ehime, Japan|Research Site, Itoshima, Fukuoka, Japan|Research Site, Yukuhashi, Fukuoka, Japan|Research Site, Annaka, Gunma, Japan|Research Site, OTA, Gunma, Japan|Research Site, Aki-gun, Hiroshima, Japan|Research Site, Sapporo, Hokkaido, Japan|Research Site, Sanuki, Kagawa, Japan|Research Site, Takamatsu, Kagawa, Japan|Research Site, Kamakura, Kanagawa, Japan|Research Site, Kawasaki, Kanagawa, Japan|Research Site, Yokohamashi, Kanagawa, Japan|Research Site, Yokohama, Kanagawa, Japan|Research Site, Zushi, Kanagawa, Japan|Research Site, Sendai, Miyagi, Japan|Research Site, Matsumoto, Nagano, Japan|Research Site, Suita, Osaka, Japan|Research Site, Otsu, Shiga, Japan|Research Site, Atami, Shizuoka, Japan|Research Site, Komatsushima, Tokushima, Japan|Research Site, Chiyoda, Tokyo, Japan|Research Site, Chuo, Tokyo, Japan|Research Site, Mitaka, Tokyo, Japan|Research Site, OTA, Tokyo, Japan|Research Site, Shibuya, Tokyo, Japan|Research Site, Shinjuku, Tokyo, Japan|Research Site, Taito, Tokyo, Japan|Research Site, Takaoka, Toyama, Japan|Research Site, UBE, Yamaguchi, Japan|Research Site, Fukuoka, Japan|Research Site, Hiroshima, Japan|Research Site, Kochi, Japan|Research Site, Osaka, Japan|Research Site, Shizuoka, Japan|Research Site, Toyama, Japan
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