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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288778
• Other study ID #: CR108749
• Secondary ID: 28431754DIA4032
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2020
• Est. completion date: July 26, 2022

Study information

• Verified date: July 2023
• Source: Johnson & Johnson Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
India	Lifecare Hospital and Research Centre	Bengaluru
India	Post Graduate Institute of Medical Education & 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	Chellaram Diabetes Institute	Pune
India	Jehangir Clinical Development Center Pvt Ltd	Pune
India	Nirmal Hospital Pvt. Ltd.	Surat
India	Jothydev's Diabetes Research Centre	Trivandrum

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Private Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24	Percent change from baseline in HbA1c at Weeks 12 and 24 was reported.	Baseline, Weeks 12 and 24