The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks.
Lifecare Hospital and Research Centre
Bengaluru, India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, India
Kovai Diabetes Specialty Centre & Hospital
Coimbatore, India
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time.
Time frame: Baseline (Day 1) up to 24 weeks
Percentage of Participants With Unexpected Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information.
Time frame: Baseline (Day 1) up to 24 weeks
Percentage of Participants With Adverse Drug Reactions (ADRs)
ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time.
Time frame: Baseline (Day 1) up to 24 weeks
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Percent change from baseline in HbA1c at Weeks 12 and 24 was reported.
Time frame: Baseline, Weeks 12 and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.)
Guwahati, India
Thumbay Hospital New life / Endocrinology
Hyderabad, India
Fortis Hospital
Mohali, India
Jehangir Clinical Development Center Pvt Ltd
Pune, India
Chellaram Diabetes Institute
Pune, India
Nirmal Hospital Pvt. Ltd.
Surat, India
Jothydev's Diabetes Research Centre
Trivandrum, India