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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04288778

28431754DIA4032 (Other Identifier)

CR108749

Details and patient eligibility

About

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

Enrollment: 276 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

276 participants in 1 patient group

Canagliflozin + Metformin Hydrochloride Immediate Release (IR)

Experimental group

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.

Treatment:

Drug: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)