NCT01452451已完成2 期
A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 72 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Number of subjects with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is male or female and 18 to 65 years of age, inclusive, at screening
- •Has a history of T2DM and a stable dose of metformin
- •Has HbA1c levels at screening between 7% and 10%
排除标准
- •Is pregnant or lactating
- •Has type 1 diabetes
- •Has a significant change in body weight in the 3 months before screening
- •Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
- •Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 <estimated glomerular filtration rate <90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio >30 mg/g.
- •Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome
- •Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.
- •Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding
- •Has any acute illness within 5 days before first study drug administration
- •Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis
- •Is a heavy tobacco user(more than 10 cigarettes a day)
- •Is a heavy alcohol user
- •Has a positive screen for drugs of abuse
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
HM11260C
Active Comparator
HM11260C
干预措施: HM11260C (Drug)
结局指标
主要结局
Number of subjects with adverse events as a measure of safety and tolerability
时间窗: Up to 106 days
Number of subjects with adverse events as a measure of safety and tolerability when given different regimens to subjects in T2DM with metformin monotherapy
次要结局
- The pharmacodynamics in repeat-dose(Up to 106 days)
- The pharmacokinetics in repeat-dose(Day 1 up to Day 92)
研究者
相似试验
已完成
2 期
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 DiabetesType 2 DiabetesNCT02057172Hanmi Pharmaceutical Company Limited254
已完成
2 期
Effect of LAPS-Exendin on Body Weight in Obese PopulationObesityNCT02075281Hanmi Pharmaceutical Company Limited297
已完成
2 期
Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 DiabetesType 2 DiabetesNCT02081118Hanmi Pharmaceutical Company Limited209
已完成
2 期
Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin DeficiencyAlpha 1-Antitrypsin DeficiencyEmphysemaNCT03114020Gerard Turino27
已完成
1 期
Safety and PK of Repeated Doses of IRL201104 in Healthy VolunteersHealthy VolunteerNCT04748536Revolo Biotherapeutics18