Mini-Dose Glucagon for Adults With Type 1 Diabetes: A Study to Assess the Efficacy and Safety of Mini-dose Glucagon for Treatment of Non-severe Hypoglycemia in Adults With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
研究概览
简要总结
The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).
详细描述
There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2) Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension Phase.
- Run-in Phase:
Prior to commencing the crossover trial, study enrollment will begin with a 2 week run-in phase to assess hypoglycemia eligibility and compliance. 2. Crossover Trial Phase:
The Crossover Trial Phase will consist of two (3-week) periods.
The Crossover Trial Phase will include up to 24 participants who complete these study periods. Participants who do not complete both periods or who do not have at least one event during both periods may be replaced.
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin
- •Age: 18.0 to < 65.0 years
- •Duration of T1D: ≥2.0 years
- •Body mass index 20.0 to <35.0 kg/m2 and weight 110 to <250 lbs
- •HbA1c <8.5% (point of care or local lab, within past month)
- •Using continuous subcutaneous insulin infusion (CSII) therapy (i.e., insulin pump) for at least 3 months, with no plans to discontinue use during the study (and no use of active low glucose suspend feature within the last 4 weeks)
- •Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study
- •Continuous glucose monitor glucose level <70 mg/dl during daytime hours (e.g., 8am - 10pm) on at least 7 of the past 28 days (a modification can be made for participants with non-traditional waking hours) evaluated from downloaded CGM data
- •Females must meet one of the following criteria:
- •Of childbearing potential and not currently pregnant (negative pregnancy test) or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening visit until study completion); or
- •Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
- •In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
- •Willing to adhere to the protocol requirements for the duration of the study
- •Participant has a smart phone available and is able to use it daily
- •Must be enrolled in the T1D Exchange clinic registry or willing to join the clinic registry
排除标准
- •More than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment)
- •More than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an episode diagnosed as diabetic ketoacidosis that required treatment in an emergency department or hospitalization)
- •Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical condition which, in the judgment of the investigator, could potentiate or predispose to undesired effects or could interfere with the absorption, distribution, metabolism, or excretion of glucagon or ability to respond appropriately to mild to moderate hypoglycemia.
- •Known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance
- •Males with alcohol use in excess of 3 or more drinks per day, on average and females with alcohol use in excess of 2 or more drinks per day, on average
- •Use of non-insulin anti-diabetic medications
- •Use of daily systemic beta-blocker
- •Use of beta-adrenergic agonists, theophylline (or other methylxanthines)
- •Use of 1st generation anticholinergic drugs (such as Brompheniramine, Chlorpheniramine, Dimenhydrinate, Diphenhydramine, and Doxylamine)
- •Use of systemic corticosteroids
- •History of hypersensitivity to glucagon or any related product or excipient or severe hypersensitivity reactions (such as angioedema) to any drugs
- •History of epilepsy or seizure disorder
- •Uncontrolled hypertension, >160 mmHg systolic or >100 mmHg diastolic
- •Currently a high endurance exerciser or plans to perform high endurance exercise during study (from screening visit until study completion)
- •High endurance exerciser defined as a person who regularly competes in running, cycling, rowing, swimming or any other endurance-based activity for the purpose of competition (>2100 metabolic equivalent of task (MET) minutes per week [i.e. 7 METs x 60 minutes x 5 days a week, where 7 METs is equivalent to jogging])
- •Currently following a very low calorie or other weight-loss diet
- •Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study
研究组 & 干预措施
G-Pen Mini™ (glucagon injection)
Participants are to check blood glucose (BG) with study meter once their continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants will be instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).
For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
干预措施: G-Pen Mini™ (glucagon injection) (Drug)
Glucose Tabs
Participants are to check their blood glucose (BG) with study meter once their continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants will be instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event).
For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
干预措施: Glucose Tablets (Other)
结局指标
主要结局
Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
时间窗: 30 minutes
次要结局
- Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level(60 Minutes)
- CGM Maximum Glucose, Event Level(120 Minutes)
- CGM Mean Glucose, Event Level(120 Minutes)
- CGM Time in Range, Event Level(120 Minutes)
- CGM Time Below 70 mg/dL, Event Level(60 Minutes)
- CGM Minimum Glucose, Event Level(120 Minutes)
- CGM Time Below 70 mg/dL(120 Minutes)
- CGM Mean Glucose(3 weeks)
- CGM Time in Range(3 weeks)
- CGM Time Below 70(3 weeks)
- CGM Coefficient of Variation(3 weeks)