NCT05537233已完成2 期
Efficacy and Safety of Once Weekly Semaglutide in Adults With Obesity and Inadequately Controlled Type 1 Diabetes Using Hybrid Closed-Loop System.
Viral N. Shah4 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2023年4月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group
研究概览
简要总结
The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.
详细描述
After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For an eligible subject, all inclusion criteria must be answered "yes"
- •Age ≥18 and ≤ 65 years
- •Patients with clinical diagnosis of T1D diagnosed for at least 12 months
- •Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months
- •Willing to use once weekly semaglutide
- •Willing to share devices (HCL system) data uploads
- •HbA1c >7.0% and <10.0%
- •Body mass index ≥30 kg/m2
- •Has current glucagon product to treat severe hypoglycemia
- •Has current ketone meters to check ketones
- •Ability to provide informed consent before any trial-related activities
排除标准
- •Age <18 years and >65 years
- •HbA1c ≤7.0 % or ≥ 10.0% at screening
- •Less than 12 months of insulin treatment
- •Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system
- •Not willing to share the devices (HCL system) data uploads
- •Non compatible devices (e.g. pump, CGM or smart phones) for data transfer
- •Current use of multiple daily injection or inhaled insulin (Afrezza)
- •Patients with T1D using any glucose lowering medications other than insulin at the time of screening
- •Pregnancy, breast feeding, and positive pregnancy test during screening
- •Women of childbearing age wanting to become pregnant
- •Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period
- •Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period
- •Use of GLP-1RA or weight loss medications in the past 3 month
- •Clinical diagnosis/history of gastroparesis or gastric motility disorders
- •Serum triglycerides >500 mg/dL
- •Planning for bariatric surgery during the study period
- •eGFR below 45 ml/min/1.73 m^2 using CKD-EPI formula
- •History of severe hypoglycemia in the previous 3 months
- •History of diabetic ketoacidosis requiring hospitalization in the past 3 months
- •History of allergy to any form of insulin, GLP-1RA or its excipients
- •History of any form of pancreatitis
- •History of stroke, myocardial infarction in the past 3 months
- •History of congestive heart failure class III or IV
- •History of acute or chronic liver disease
- •History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years
- •Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma
- •Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusion only if doing MRI)
- •Use of investigational drugs within 5 half-lives prior to screening
- •Participation to other intervention trials during the study period
- •Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators
研究组 & 干预措施
Semaglutide
Experimental
Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy
干预措施: Semaglutide (Drug)
Control
Placebo Comparator
Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group
时间窗: 26 weeks
Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.
次要结局
- Change in HbA1c(26 weeks)
- Change in Mean Glucose(26 weeks)
- Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)(26 weeks)
- Percent Time Spent in CGM-measured Glucose >180 mg/dL(26 weeks)
- Percent Time Spent in CGM-measured Glucose >250mg/dL(26 weeks)
- Percent Time Spent in CGM-measured Glucose <70mg/dL(26 weeks)
- Change in CGM Measured Glycemic Variability (Coefficient of Variation)(26 weeks)
- Change in Weight(26 weeks)
- Change in BMI (Kg/m2)(26 weeks)
- Severe Hypoglycemia(26 weeks)
研究者
Viral N. Shah
Professor of Medicine, Division of Endocrinology & Metabolism
Indiana University
研究点 (4)
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