A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
Intervention description: 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.
Intervention MeSH terms: Metformin; Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride
      immediate Release (IR) fixed-dose combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant willing to adhere to diet and exercise regimen as recommended by the
             investigator

          -  Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise,
             who in investigator's opinion are eligible to receive study drug as per prescribing
             information along with standard care for management of T2DM

          -  Women must be postmenopausal, defined as greater than (>) 45 years of age with
             amenorrhea for at least 18 months, or > 45 years of age with amenorrhea for at least 6
             months and less than (<) 18 months and a serum follicle stimulating hormone (FSH)
             level > 40 International Units Per Liter (IU/L), or surgically sterile (have had a
             hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of
             pregnancy, or sexually active and practicing a highly effective method of birth
             control, including hormonal prescription oral contraceptives, contraceptive
             injections, contraceptive patch, tubal ligation, intrauterine device, double-barrier
             method (example, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or
             gel), or male partner sterilization, and consistent with local regulations regarding
             use of birth control methods for participant participating in clinical studies, for
             the duration of their participation in the study, or not sexually active

          -  Women of childbearing potential, regardless of age must have a negative serum
             beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and negative
             UPT at baseline (predose, Day 1)

          -  Treatment naive participants or participants on stable antihyperglycemic agent (AHA)
             therapy (for at least 12 weeks before screening) and have a screening visit
             Glycosylated Haemoglobin (HbA1c) of greater than or equal to (>=) 7.0 percent (%) and
             less than or equal to (<=) 10.0 %

        Exclusion Criteria:

          -  History of liver or renal insufficiency (estimated creatinine clearance below 45
             milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary,
             gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
             metabolic disturbances

          -  Known allergies, hypersensitivity, or intolerance to Canagliflozin, Metformin or
             Canagliflozin + metformin hydrochloride immediate release (IR) Fixed Dose combination
             (FDC) or its excipients

          -  Use of any other sodium glucose cotransporter 2 (SGLT2) inhibitor within 12 weeks
             before the screening visit

          -  If female, the participant is pregnant or lactating or intending to become pregnant
             before, during, or within 30 days after last dose of study medication; or intending to
             donate ova during such time period

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or
             beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy