NCT01933256已完成1 期
A Randomized, Double-blind, Placebo-controlled Study of the Effect of 49 Days of Treatment With Repeated Subcutaneous Doses of HIP2B to Assess Safety, Tolerability and Measures of Islet β-cell Function in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
CureDM1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus.
研究概览
简要总结
HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.
The purpose of this study is to investigate the safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet β-cell number and function will increase over time in response to repeat HIP2B injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30 to 65 years, inclusive
- •Males and females
- •Diagnosis of type 2 diabetes mellitus prior to screening meeting the following criteria:
- •Body mass index <45 kg/m2
- •HbA1c value of > 6.5 to <9.5%
- •C-peptide ≥1.0 ng/mL
- •On a stable dose of metformin for 12 weeks
- •Ability to provide written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
排除标准
- •History of any of the following: type 1 diabetes mellitus, diabetic ketoacidosis, an episode of severe hypoglycemia (defined as a change in mental status requiring assistance) during the prior 30 days
- •FPG >260 mg/dL at time of randomization
- •Current or chronic use (within past 12 weeks) of insulin, or insulin secretagogues including: sulfonylureas, GLP-1 analogs, DPP-4 inhibitors, meglitinides, α-glucosidase inhibitors, pioglitazone, or rosiglitazone
- •Glomerular filtration rate (GFR) <60 as calculated using the Modified Diet in Renal Disease equation at screening
- •ALT, AST or total bilirubin > 2 X ULN
- •Serum amylase concentration > 1.5XULN or serum lipase concentration >2XULN
- •Positive test result for glutamic acid decarboxylase antibodies (GADA).
- •The presence of a clinically significant abnormality on resting electrocardiogram (ECG)
- •Positive HIV, hepatitis B (HBsAg), or positive hepatitis C (HCV Ab) test at screening
- •History of clinically significant renal, hepatic, cardiovascular, neurological, or gastrointestinal disease that could impact patient safety in the investigator's opinion
- •Serum triglycerides >500 mg/dL
- •Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer
- •History of weight loss > 5% in the 8 weeks prior to randomization or subject is on a weight loss program and is not in the maintenance phase
- •Use of any weight loss medication within 8 weeks of randomization
- •Uncontrolled hypertension defined as blood pressure >160/100 mmHg, using an appropriately sized cuff, at rest
- •History or evidence of multiple organ autoimmune disorders
- •History of thyroid dysfunction other that hypothyroidism treated with stable dose of thyroid hormone and euthyroid at screening
- •History or presence of acute or chronic pancreatitis or symptomatic recurrent gallstones
- •Has undergone surgery within 6 months of screening or plans to undergo surgery during the study period
- •Use of parenterally administered proteins or antibodies within 12 weeks of screening. (Note: Influenza vaccine will be allowed.)
- •Prior exposure to any investigational agent or participation in an investigational trial within 30 days prior to Day 1
- •Blood loss or blood donation >500 ml in the 2 months prior to screening.
- •Use of systemic long-acting corticosteroids within two months or prolonged use (more than one week) of other systemic corticosteroids or inhaled corticosteroids (if daily dosage is >1000 mcg equivalent beclomethasone) within 30 days prior to screening visit.
- •Drugs with the potential to affect (either increasing or decreasing) endogenous insulin secretion or insulin sensitivity including corticosteroids (as detailed above), β-adrenergic blockers, beta-adrenergic agonists, quinine, thiazide or thiazide-like diuretics, calcineurin inhibitors, niacin, anti-psychotic or antidepressant drugs, somatostatin analogs, growth hormone, weight-reducing drugs (e.g. orlistat, phentermine and topiramate extended-release, lorcaserin). Stable doses of agents commonly required by subjects with T2DM including angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, statins, fibrates, and aspirin (<100 mg daily) will be permitted at the discretion of the investigator.
- •A serious adverse reaction or hypersensitivity to any drug, unless reaction deemed irrelevant to the study by the investigator and sponsor.
- •History of alcohol abuse or drug abuse within the previous 12 months. No history of medical or recreational use of marijuana within previous 12 months.
- •A history of smoking more than one-half a pack of cigarettes per day within last 12 months
- •History of stroke, transient ischemic attack or myocardial infarction within 6 months prior to screening.
- •History of New York Heart Association Class II-IV heart failure prior to screening.
研究组 & 干预措施
600mg HIP2B
Experimental
600mg HIP2B
干预措施: HIP2B (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
400mg HIP2B
Experimental
400mg HIP2B
干预措施: HIP2B (Drug)
结局指标
主要结局
The safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus.
时间窗: Adverse Events / vitals are monitored at each study visit between Days -9 and 84.
Safety evaluations will include clinical observation and adverse event (AE) reporting; evaluation of the injection site, physical examination, vital signs; electrocardiograms (ECGs), hematology, chemistry panels (inclusive of expanded markers of liver function), dipstick urinalysis (microscopic evaluation if dipstick positive), amylase, LDH.
次要结局
- Glucose-stimulated insulin secretion.(IVGTT performed on Day -8 and Day 49. GGI performed on Day -1, Day 25 and Day 46.)
研究者
研究点 (1)
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