This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
728
Oral Dose 5 or 10 mg
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Owariasahi, Aichi-ken, Japan
Research Site
Toyohashi, Aichi-ken, Japan
Research Site
Hirosaki, Aomori, Japan
Research Site
Niihama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Itoshima, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Annaka, Gunma, Japan
Research Site
Ōta, Gunma, Japan
...and 28 more locations
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 52