Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
研究概览
简要总结
This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old.
The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group.
We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.
详细描述
Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months.
Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C [HbA1c]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;
- •Written informed consent of study participation
- •Males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday);
- •HbA1c at screening between 7.0% and 10.0%, inclusive;
- •Fasting C-peptide >0.6 ng/mL; and
- •Anti-diabetic treatment at screening:
- •Treatment-naïve or untreated; OR
- •On metformin monotherapy: Metformin monotherapy has been initiated prior to screening.
排除标准
- •Fasting plasma glucose >270 mg/dL;
- •Diagnosis of type 1 diabetes;
- •History of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus;
- •Clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and Hb variants, that are not within the protocol-defined parameters
- •Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg
- •Use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids
- •Genetic syndrome or disorder known to affect glucose
- •Participation in a weight loss program or another interventional research study within 60 days;
- •Female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening;
- •Female participants who are sexually active and unwilling to use appropriate contraception for the duration of the study;
- •History of bowel obstruction;
- •Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the Investigator, would prevent full participation
研究组 & 干预措施
Colesevelam
High-dose colesevelam suspended in a drink for oral administration once daily with dinner
干预措施: High-dose colesevelam (Drug)
Placebo proxy
Low-dose colesevelam suspended in a drink for oral administration once daily with dinner
干预措施: Low-dose colesevelam (Drug)
结局指标
主要结局
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
时间窗: Baseline to Month 6 post-dose
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
次要结局
- Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12(Baseline to Month 12 post-dose)
- Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria(Baseline to Month 12 post-dose)
- Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12(Baseline to Month 12 post-dose)
- Number of Participants Achieving a Response to Therapy to Month 12(Baseline to Month 12 post-dose)
- Percent Change From Baseline to Month 6 in Triglycerides(Baseline to Month 6 post-dose)
- Percent Change From Baseline to Month 6 in Plasma Lipids(Baseline to Month 6 post-dose)