Clinical trial NCT04288778: 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
Official title: A Prospective, Multi-centric, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety and Efficacy of Canagliflozin + Metformin Hydrochloride IR Fixed-dose Combination as an Adjunct to Diet and Exercise to Improve Glycemic Control in Indian Adult Patients With Type 2 Diabetes Mellitus When Treatment With Both Canagliflozin and Metformin is Appropriate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline (Day 1) up to 24 weeks
measure: Percentage of Participants With Unexpected Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to 24 weeks
measure: Percentage of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Baseline (Day 1) up to 24 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Lifecare Hospital and Research Centre
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education And Research PGIMER
city: Coimbatore
country: India
facility: Kovai Diabetes Specialty Centre & Hospital
city: Guwahati
country: India
facility: Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.)
city: Hyderabad
country: India
facility: Thumbay Hospital New life / Endocrinology
city: Mohali
country: India
facility: Fortis Hospital
city: Pune
country: India
facility: Jehangir Clinical Development Center Pvt Ltd
city: Pune
country: India
facility: Chellaram Diabetes Institute
city: Surat
country: India
facility: Nirmal Hospital Pvt. Ltd.
city: Trivandrum
country: India
facility: Jothydev's Diabetes Research Centre
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: