NCT02526524已完成2 期
Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 136
- 主要终点
- Change in HbA1c (%) at 16 Weeks
研究概览
简要总结
The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning [qAM]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 25 years old at Visit 1 (Screening).
- •Is male, or is female and meets all of the following criteria:
- •Not breastfeeding
- •Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
- •Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study.
- •Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
- •Has a physical examination with no clinically significant abnormalities as judged by the investigator.
- •Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit
- •Has an estimated glomerular filtration rate (eGFR) value of ≥60 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation.
- •Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Visit 1:
- •Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and alpha-glucosidase inhibitors
- •Hormone replacement therapy (female subjects) and testosterone (male subjects)
- •Oral contraceptives (female subjects)
- •Antihypertensive agents
- •Lipid-lowering agents
- •Thyroid replacement therapy
- •Antidepressant agents
- •Ability to understand and willingness to adhere to protocol requirements.
排除标准
- •Has a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:
- •Hepatic disease
- •Gastrointestinal disease
- •Endocrine disorder (T2DM is allowed)
- •Cardiovascular disease
- •Central nervous system diseases
- •Psychiatric or neurological disorders
- •Organ transplantation
- •Chronic or acute infection
- •Orthostatic hypotension, fainting spells or blackouts
- •Allergy or hypersensitivity.
- •A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
- •Prior major surgery of any kind within 6 months of Visit
- •A history of >3% weight change within 3 months of Visit
- •A clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormality, other than that related to T2DM, judged by the investigator to be clinically significant at Visit
- •An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
- •A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
- •Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
- •Metformin within 2 months of Visit 1 (Screening)
- •Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3 months of Visit 1 (Screening)
- •Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2 inhibitors within 3 months of Visit 1
- •Drugs known to affect body weight, including prescription medications and over-the-counter anti obesity agents within 3 months of Visit
- •Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of Visit 1
- •Planned use of any drug treatment that affects gastric pH (prescription or over-the-counter), such as H2-receptor antagonists and proton pump inhibitors, after Visit 2 (Week -2), or planned chronic use of any antacids (i.e., more than twice per week) after Visit 2 (Week -2)
- •Cationic drugs that are eliminated by renal tubular secretion within 1 week of Visit
- •Iodinated contrast dye within 1 week prior to Visit
- •Investigational drug within 2 months (or five half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication.
- •Met DR or double-blind matching placebo for Met DR at any time prior to Visit 1 (Screening)
- •Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures.
- •Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 2 months prior to Visit 1 (Screening), or is planning to donate blood during the study.
- •Has known immune system based allergies or hypersensitivity to any component of study treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.
- •Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or designee of the company).
- •Has a fasting plasma glucose value >270 mg/dL at Visit 1 (Screening), Visit 2 (Week -2), and an unscheduled visit to be completed within 1 week following Visit
- •The unscheduled visit is to be completed only for subjects with a fasting plasma glucose value >270 mg/dL at Visit 1 and Visit 2.
研究组 & 干预措施
600 mg Met DR qAM
Experimental
600 mg metformin delayed-release once daily in the morning
干预措施: Met DR (Drug)
900 mg Met DR qAM
Experimental
900 mg metformin delayed-release once daily in the morning
干预措施: Met DR (Drug)
1200 mg Met DR qAM
Experimental
1200 mg metformin delayed-release once daily in the morning
干预措施: Met DR (Drug)
1500 mg Met DR qAM
Experimental
1500 mg metformin delayed-release once daily in the morning
干预措施: Met DR (Drug)
Placebo-1
Placebo Comparator
placebo match for 600 and 1200 mg Met DR qAM treatment groups
干预措施: Placebo (Drug)
Placebo-2
Placebo Comparator
placebo match for 900 and 1500 mg Met DR qAM treatment groups
干预措施: Placebo (Drug)
2000 mg Met IR
Active Comparator
1000 mg metformin immediate-release twice daily
干预措施: Met IR (Drug)
结局指标
主要结局
Change in HbA1c (%) at 16 Weeks
时间窗: Baseline and 16 weeks after the first dose of study medication
次要结局
未报告次要终点
研究者
研究点 (136)
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