Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
研究概览
简要总结
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Inadequate glucose control while using metformin monotherapy (MET) for at least 8 weeks at stable daily doses of at least 1500 milligram (mg) before screening visit (Visit 1)
- •a. Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 10.5% at Visit 1
- •Adequate qualifying continuous glucose monitoring (CGM) reading during the pre-randomization (selection) phase
- •Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute (mL/min)/1.73 meter square (m^2) at Visit 1
- •Body mass index of 22 through 45 kilogram per meter square (kg/m^2) at Visit 1
排除标准
- •History of any of the following (at Visit 1):
- •Diabetic ketoacidosis (DKA)
- •Type 1 diabetes mellitus (T1DM)
- •Pancreatic (for example, Beta-islet cell) transplantation
- •Diabetes secondary to pancreatitis or pancreatectomy
- •Personal history of, or ongoing, pancreatitis
- •One or more episodes of severe hypoglycemia (requiring assistance from others), as documented in the history obtained at Visit 1
- •Hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG) greater than (>) 270 milligram per deciliter (mg/dL) during the pre-treatment phase
- •Treatment with any other oral or parenteral antidiabetic medications different from metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1 receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and investigational agents
- •Received an investigational drug or vaccine or used an invasive investigational medical device within 30 days before the planned first dose of study drug
- •Current use of "natural medicines" or natural medicinal products for diabetes (for example, cactus-derived nutrients, celery)
研究组 & 干预措施
Treatment Sequence BA
Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
干预措施: Sitagliptin 100 mg (Drug)
Treatment Sequence BA
Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
干预措施: Canagliflozin 300 mg (Drug)
Treatment Sequence AB
Participants will receive metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
干预措施: Sitagliptin 100 mg (Drug)
Treatment Sequence AB
Participants will receive metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
干预措施: Canagliflozin 300 mg (Drug)
Treatment Sequence AB
Participants will receive metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
干预措施: Metformin (Drug)
Treatment Sequence BA
Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
时间窗: Baseline up to End of Treatment Period 1 (Days 22 to 27)
Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
时间窗: Baseline up to End of Treatment Period 2 (Days 66 to 71)
Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
次要结局
- Change From Baseline in Mean 24-hour Glucose Profile(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Fasting Plasma Glucose Levels(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Time Spent With Glucose Level > 140 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Time Spent With Glucose Level > 180 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Time Spent With Glucose Level < 70 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))
- Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL(Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71))