CTRI/2022/07/044269招募中3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-LabelExtension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide inPediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled withMetformin, or Basal Insulin, or Both (SURPASS-PEDS)
Eli Lilly and Company India Pvt Ltd6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年8月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c).
研究概览
简要总结
The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 10.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, aged 10 to below 18 years at screening visit
- •Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin.
- •Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
- •Have HbA1c >6.5% to ≤11% at screening
- •Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.
排除标准
- •Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies.
- •After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome.
- •Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
- •Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- •Had chronic or acute pancreatitis any time prior to study entry.
- •Female participants who are pregnant or breast feeding or intending to become pregnant.
- •Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c).
时间窗: Baseline, Week 30
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide(Baseline to Week 30)
- 1. Change From Baseline in PedsQL Generic Core Scale.(2. Change From Baseline PedsQL (3.2) Diabetic Module)
- 1. Change from Baseline in HbA1c (Individual Doses).(2. Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched).)
- 1. Percentage of Participants Who Achieve ≤6.5% of HbA1c.(2. Percentage of Participants Who Achieve less than 7.0% of HbA1c.)
研究者
研究点 (6)
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