NCT02317796已完成2 期
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
Melior Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2014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
- 149
- 试验地点
- 1
- 主要终点
- Change in PPG AUC0-3h in a MMTT between Days 1 and 29.
研究概览
简要总结
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
详细描述
Objectives
- To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus
- To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1 following 28 days of repeat dosing
Design and Outcomes
The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023 in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise therapy.
A subset of subjects per dose group will have additional samples analyzed to measure signs of MLR-1023.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged ≥ 18 - ≤ 75 years
- •Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception
- •BMI ranging from ≥ 20 to ≤ 40 kg/m2
- •Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3)
- •(i) naïve or (ii) currently using and discontinued metformin or (iii) no prior exposure to anti-diabetic agents other than metformin ≥ 6 months prior to screening
排除标准
- •History of Type 1 diabetes
- •History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness.
- •Hospitalizations or Emergency room visits that would impact patient safety or data interpretation:
- •Due to poor glucose control in the 6 months prior to screening or
- •Any bariatric surgical procedures for weight loss.
- •Significant change of body weight (>10%) in the 3 months before screening
- •Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: MLR-1023 (Drug)
100 mg q.d.
Active Comparator
干预措施: MLR-1023 (Drug)
100 mg b.i.d.
Active Comparator
干预措施: MLR-1023 (Drug)
200 mg q.d.
Active Comparator
干预措施: MLR-1023 (Drug)
200 mg b.i.d.
Active Comparator
干预措施: MLR-1023 (Drug)
结局指标
主要结局
Change in PPG AUC0-3h in a MMTT between Days 1 and 29.
时间窗: 29 Days
次要结局
- Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36(36 Days)
- Change in fructosamine level from Day 1 to Day 29(29 Days)
- Change in fasting insulin from Day 1 to Day 29(29 Days)
- Change in glycated albumin from Day 1 to Day 29(29 Days)
- Change from Day 1 to Day 29 in insulin sensitivity using HOMA-R (HOMA-R = fasting plasma insulin (mU/l) * fasting plasma glucose (mmol/l) / 22.5)(29 Days)
- Changes from Day 1 to Day 29 in beta-cell function using HOMA-B (HOMA-B = 20 * fast- ing plasma insulin (mU/l) / [fasting plasma glucose (mmol/l) - 3.5])(29 Days)
- Change in HbA1C between Days 1 and Day 29(29 Days)
- Changes in LDL-C, HDL-C, TG between Days 1 and Day 29(29 Days)
- Change in weight between Days 1 and Day 29(29 Days)
- Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29.(29 Days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and ExerciseType 2 Diabetes MellitusNCT05666128Hyundai Pharm112
已完成
2 期
Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisNCT02738801Galapagos NV23
尚未招募
1 期
Evaluate the Efficacy and Safety of EN001 in Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyNCT06328725ENCell88
已完成
2 期
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral InfectionsAcute Respiratory Viral InfectionsInfluenzaNCT03455491PHARMENTERPRISES LLC120
Unknown
2 期
A Study of TG103 Injection in Overweight or ObesityOverweight or ObesityNCT05299697CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.195