EUCTR2020-005745-16-DK进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 (SGL) < 3.9 mmol/l on = 4/14 previous days assessed by CGM data
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
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
- •Know or suspected allergies to glucagon or related products
- •History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients (refer to Table 1 in the Investigators brochure)
- •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 (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
- •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
研究者
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