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
NCT ID: NCT04288778
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
276 participants
INTERVENTIONAL
2020-11-25
2022-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Canagliflozin + Metformin Hydrochloride Immediate Release (IR)
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.
Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
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.
Interventions
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Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Johnson & Johnson Private Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Private Limited Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Private Limited
Locations
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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
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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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28431754DIA4032
Identifier Type: OTHER
Identifier Source: secondary_id
CR108749
Identifier Type: -
Identifier Source: org_study_id
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