Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of MBX-2044 to Evaluate the Multiple-dose Pharmacokinetics, Safety and Tolerability When Administered Orally in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
研究概览
简要总结
The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
详细描述
The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or Byetta®
- •All female patients must be either surgically sterile or post-menopausal.
- •Male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
- •BMI 24-44 kg/m
- •Patients must have a FPG ≤ 200 mg/dL at screening.
- •Patients must have Hemoglobin A1c ≥ 6.5%, ≤ 10.0% at screening.
- •Electrocardiogram (ECG) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
- •Patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.
排除标准
- •History of Type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
- •History of TZD use (Actos or Avandia) within 6 months of Screening Visit.
- •History of TZD discontinuation due to lack of efficacy.
- •History of congestive heart failure within last 5 years.
- •History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
- •Malignancy within the last 5 years (except resected basal cell carcinoma).
- •Ongoing active infection.
- •Change in treatment with lipid-lowering agent within 7 days of screening visit.
- •Current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or Plavix® ≤ 75 mg/d].
- •Current or expected treatment with phenytoin for the duration of the study.
- •Known hypersensitivity to NSAIDs.
研究组 & 干预措施
MBX-2044 1.5 mg
干预措施: MBX-2044 (Drug)
MBX-2044 4.5 mg
干预措施: MBX-2044 (Drug)
MBX-2044 15 mg
干预措施: MBX-2044 (Drug)
MBX-2044 30 mg
干预措施: MBX-2044 (Drug)
MBX-2044 60 mg
干预措施: MBX-2044 (Drug)
MBX-2044 90 mg
干预措施: MBX-2044 (Drug)
Placebo
干预措施: Placebo for MBX-2044 (Drug)
结局指标
主要结局
Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters
Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
次要结局
未报告次要终点