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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 %
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination) (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions (ADRs)
时间窗: Baseline (Day 1) up to 24 weeks
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.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
时间窗: Baseline (Day 1) up to 24 weeks
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.
Percentage of Participants With Unexpected Adverse Events (AEs)
时间窗: Baseline (Day 1) up to 24 weeks
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.
次要结局
- Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24(Baseline, Weeks 12 and 24)