2022-501085-21-00已完成3 期
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Mellitus (MK-8835-059/B1521066)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 15
- 主要终点
- Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo)
研究概览
简要总结
- To compare the addition of ertugliflozin with the addition of placebo on the change from baseline in hemoglobin A1C (A1C) at 24 weeks.
- To assess the safety and tolerability of ertugliflozin over 24 weeks and 54 weeks.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
- •Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
- •T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening.
- •On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
- •Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.
排除标准
- •Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
- •Has known monogenic diabetes, or secondary diabetes.
- •Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
- •Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
- •Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
- •Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
- •Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
- •Has a history of severe hypoglycemia while on insulin.
结局指标
主要结局
Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo)
Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo)
Number of Participants Who Experience an Adverse Event (AE) over 24 weeks
Number of Participants Who Experience an Adverse Event (AE) over 24 weeks
Number of Participants Who Experience an AE over 54 weeks
Number of Participants Who Experience an AE over 54 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE over 24 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE over 24 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks
次要结局
- Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo)
- Change from Baseline in Hemoglobin A1C at Week 24 (ertugliflozin 5 mg versus placebo)
- Change from Baseline in Fasting Plasma Glucose (FPG) at 24 weeks
- Change from Baseline in Hemoglobin A1C at 54 weeks
- Change from Baseline in FPG at 54 weeks
研究者
Ravi Shankar
Scientific
Merck Sharp & Dohme LLC
研究点 (15)
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