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

NCT04288778 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CR10874928431754DIA4032
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (Day 1) up to 24 weeks

Secondary Outcomes (1)

• Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24

  Baseline, Weeks 12 and 24

Study Arms (1)

Canagliflozin + Metformin Hydrochloride Immediate Release (IR)

EXPERIMENTAL

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.

Drug: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)

Interventions

Canagliflozin + Metformin hydrochloride (Fixed Dose Combination) DRUG

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.

Also known as: JNJ-28431754

Canagliflozin + Metformin Hydrochloride Immediate Release (IR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Private Limited: lead

Study Sites (10)

Lifecare Hospital and Research Centre

Bengaluru, 560092, India

Location

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, 160012, India

Location

Kovai Diabetes Specialty Centre & Hospital

Coimbatore, 641 009, India

Location

Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.)

Guwahati, 781033, India

Location

Thumbay Hospital New life / Endocrinology

Hyderabad, 500024, India

Location

Fortis Hospital

Mohali, 160062, India

Location

Jehangir Clinical Development Center Pvt Ltd

Pune, 411001, India

Location

Chellaram Diabetes Institute

Pune, 411021, India

Location

Nirmal Hospital Pvt. Ltd.

Surat, 395002, India

Location

Jothydev's Diabetes Research Centre

Trivandrum, 695032, India

Location

Related Publications (1)

• LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.

  PMID: 39971605 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Canagliflozin; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Medical Advisor
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Johnson & Johnson Private Limited Clinical Trial

  Johnson & Johnson Private Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: November 25, 2020
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: March 30, 2025
• Results First Posted: August 18, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (10)