NCT04764968已完成2 期
Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study
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
- 24
- 试验地点
- 1
- 主要终点
- Difference in percentage of time in range between the two study periods
研究概览
简要总结
The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.
详细描述
A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •T1D ≥ 2 years
- •Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months
- •Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days
- •HbA1c ≤ 70 mmol/l (8.5%)
- •Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
- •Use of carbohydrate counting and bolus calculator (self-reported)
- •Sensor glucose level < 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data
排除标准
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
- •Known or suspected allergies to glucagon or related products
- •History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
- •Patients with pheochromocytoma or insulinoma
- •Hypoglycemia unawareness
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •Inability to understand the individual information and to give informed consent
- •Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
- •Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
研究组 & 干预措施
Dasiglucagon
Experimental
During the 'dasiglucagon' period, participants will use pen-administered low-dose (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia.
干预措施: Dasiglucagon (Drug)
结局指标
主要结局
Difference in percentage of time in range between the two study periods
时间窗: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l
次要结局
- Difference in percentage of time in hyperglycemia between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference in percentage of time in hypoglycemia between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference in coefficient of variation (%) between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference between successful cases (%) of hypoglycemia treatment between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference in successful cases (%) of hypoglycemia prevention between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference in time from hypoglycemia treatment to euglycemia between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration(2-week 'dasiglucagon' period)
- Difference between the average daily carbohydrate intake between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference between the average total daily insulin dose between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods(2-week 'usual care' period and 2-week 'dasiglucagon' period)
- Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire(At the end-of-study visit (estimated week 6))
- Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies(Measured 4 weeks after the 'dasiglucagon' period)
研究者
研究点 (1)
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