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
Study Details
Study Description
Brief Summary
The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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 Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [24 Weeks]
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. A SAE defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
- Percentage of Participants with Unexpected AE or Adverse Drug Reactions as a Measure of Safety and Tolerability [24 Weeks]
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Unexpected AE event is considered unlisted if the nature or severity is not consistent with the applicable product reference safety information (Investigator's Brochure or local prescribing information). Adverse drug reactions are defined as adverse events which are in the investigator's opinion of causal relationship to the study treatment.
Secondary Outcome Measures
- Percent Change From Baseline in Glycosylated Haemoglobin (HbA1c) [Baseline, Week 12 and 24]
Percent change from baseline in HbA1c will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant willing to adhere to diet and exercise regimen as recommended by the investigator
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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
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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
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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)
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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:
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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
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Known allergies, hypersensitivity, or intolerance to Canagliflozin, Metformin or Canagliflozin + metformin hydrochloride immediate release (IR) Fixed Dose combination (FDC) or its excipients
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Use of any other sodium glucose cotransporter 2 (SGLT2) inhibitor within 12 weeks before the screening visit
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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
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History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lifecare Hospital and Research Centre | Bengaluru | India | 560092 | |
| 2 | Post Graduate Institute of Medical Education & Research (PGIMER) | Chandigarh | India | 160012 | |
| 3 | Kovai Diabetes Specialty Centre & Hospital | Coimbatore | India | 641 009 | |
| 4 | Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.) | Guwahati | India | 781033 | |
| 5 | Thumbay Hospital New life / Endocrinology | Hyderabad | India | 500024 | |
| 6 | Fortis Hospital | Mohali | India | 160062 | |
| 7 | Jehangir Clinical Development Center Pvt Ltd | Pune | India | 411001 | |
| 8 | Chellaram Diabetes Institute | Pune | India | 411021 | |
| 9 | Nirmal Hospital Pvt. Ltd. | Surat | India | 395002 | |
| 10 | Jothydev's Diabetes Research Centre | Trivandrum | India | 695032 |
Sponsors and Collaborators
- Johnson & Johnson Private Limited
Investigators
- Study Director: Johnson & Johnson Private Limited Clinical Trial, Johnson & Johnson Private Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108749
- 28431754DIA4032