NCT02307279已完成不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 36
- 主要终点
- Co-Primary Outcome: Percent Change in Body Weight
研究概览
简要总结
This study will asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.
详细描述
To asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 to 65 years of age, inclusive
- •Signed Informed Consent Form
- •BMI 27 to 40, inclusive (BMI of <30 should have at least one comorbidity)
- •Fasting plasma glucose 90mg/dL to 145 mg/dL, inclusive; non-diabetic normoglycemic (fasting glucose 90 mg/dL to 100 mg/dL, inclusive); non-diabetic impaired fasting glucose 100mg/dL to 126 mg/dL; and diabetic: untreated (126 mg/dL to 145 mg/dL, inclusive) and metformin-treated (metformin dose 1500mg/DL and less, fasting glucose less than 145 mg/dL, inclusive)
排除标准
- •Pregnancy or lactation
- •Absence of medically approved contraceptive methods in females of childbearing potential
- •History of allergic reaction to modified cellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, and titanium oxide
- •Administration of investigational products within 1 month prior to Screening Visit
- •Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
- •Subjects anticipating surgical intervention during the study
- •Known Type 1 diabetes
- •History of eating disorders
- •Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- •History of: swallowing disorders, esophogeal anatomic abnormalities, gastroesophageal reflux disease, gastric or duodenal ulcer, gastroparesis (chronic nausea, vomiting, heartburn...), gastric bypass or other gastric surgery, intestinal obstruction or at high risk of including suspected small bowel adhesion, pancreatitis, malabsorption, history of bowel resection (except if related to appendectomy), history of abdominal radiation treatment
- •Laxative users
- •History of: HIV, hepatitis B or C; cancer within the past 5 years
- •Abnormal serum thyroid-stimulating hormone (TSH)
- •Positive urine drug test
- •Anti-obesity medication within 1 month prior to Screening Visit (except stable doses of metformin, no more than 1500 mg/day, for at leaset 1 month in subjects with type 2 diabetes)
- •Systemic corticosteroids within 1 month prior to Screening Visit
- •Thyroid hormones or preparations within 1 month prior to Screening Visit
- •Estrogen within 1 month prior to Screening Visit
- •Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
- •TSH suppression therapy for thyroid cancer
- •medications requiring mandatory administration with meal (lunch or dinner), except metformin
- •Other medication or product used for chronic diseases if their impaired gastrointestinal absorption can cause safety issues
- •Change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose)
- •Anticipated requirement for use of prohibited concomitant medication
研究组 & 干预措施
Gelesis100
Experimental
Gelesis100 twice daily
干预措施: Gelesis100 (Device)
Placebo
Placebo Comparator
Matching placebo twice daily
干预措施: placebo (Device)
结局指标
主要结局
Co-Primary Outcome: Percent Change in Body Weight
时间窗: Baseline to Day 171
Percent change in body weight from Baseline to Day 171 is presented.
Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%
时间窗: Baseline to Day 171
Percentage of participants who achieve a body weight loss ≥ 5% from Baseline to Day 171 is presented.
次要结局
- Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.(Baseline to Day 171)
- Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline(Baseline to Day 171)
- Percent Change in Plasma Glucose(Baseline to Day 171)
- Change in Body Mass Index (BMI)(Baseline to Day 171)
- Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline(Baseline to Day 171)
研究者
研究点 (36)
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