NCT04673656已完成不适用
Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioKier Inc.
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Changes in HOMA-IR
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females between the ages of 18 and 70 years at the time of screening, inclusive
- •Diagnosed with T2D and under the care of a healthcare professional for its management, or newly diagnosed (as participant in the study) with T2D
- •HbA1c 6.5% -10.5%, inclusive
- •Has given written informed consent to participate in this study
- •Willing to complete 84-day test period
- •Willing to maintain current diet and exercise routine and current prescription medications for the duration of the study
排除标准
- •Type 1 diabetes
- •History of bariatric or intestinal surgery
- •Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis
- •Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
- •History of heart disease that in the opinion of the investigator should exclude the subject from the study
- •Severely uncontrolled hypertension at screening defined as a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
- •Active significant infection as determined by the investigator
- •Known allergy to butyrate or any of the components of the tablets
- •Subjects planning to make major changes to diet and physical activity during the trial duration
- •Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
- •Pregnant, nursing, or trying to become pregnant
- •In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
- •Subject is taking one or more of the excluded therapies.
结局指标
主要结局
Changes in HOMA-IR
时间窗: Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84
Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA
次要结局
- Changes in HbA1c(Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84)
- Changes in fasting glucose(Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84)
- Changes in fasting low-density lipoprotein-cholesterol (LDL-C)(Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84)
- Changes in fasting triglycerides(Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84)
- Changes in fasting insulin(Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84)
研究者
研究点 (6)
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