Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Volunteers With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
研究概览
简要总结
The investigators are doing this research study to find out if the type of needle used to administer them affects the speed with which insulin and glucagon get into the blood. The investigators will compare a traditional insulin needle to an injection device, called the MicronJet, that uses microneedles to deliver medication into the top layer of your skin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older with clinical type 1 diabetes for at least one year
- •Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (Novolog), insulin lispro (Humalog), and insulin glulisine (Apidra).
- •Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 5 units of rapid acting insulin
- •Stimulated C-peptide <0.1 nmol/L at 90 minutes after liquid mixed meal tolerance test.
排除标准
- •Unable to provide informed consent
- •Unable to comply with study procedures
- •Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trails of passive monitoring equipment, such as continuous glucose monitors (CGMs), are not excluded
- •Inadequate venous access as determined by study nurse or physician at time of screening
- •Pregnancy
- •Hemoglobin less than 13.5 for men and less than 12 for women
- •History of pheochromocytoma (fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor to include episodic or treatment refractory hypertension defined as requiring 4 or more medications to achieve normotension, paroxysms of tachycardia, pallor, or headache, or personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease)
- •History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
- •History of adrenal disease or tumor
- •Hypertension (blood pressure > 160/100 mm/Hg at screening or day of study visit
- •History of allergy to aspirin or any history of aspirin intolerance, including Reye's syndrome, or gastric ulcer or bleeding associated with salicylates.
- •Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrand's disorder, and idiopathic thrombocytopenic purpura (ITP)
- •Peptic Ulcer
研究组 & 干预措施
Intradermal first
Intradermal injection experiment first, followed by subcutaneous injection experiment
干预措施: Intradermal injection (Procedure)
Intradermal first
Intradermal injection experiment first, followed by subcutaneous injection experiment
干预措施: Subcutaneous injection (Procedure)
Subcutaneous first
Subcutaneous injection experiment first, followed by intradermal injection experiment
干预措施: Subcutaneous injection (Procedure)
Subcutaneous first
Subcutaneous injection experiment first, followed by intradermal injection experiment
干预措施: Intradermal injection (Procedure)
结局指标
主要结局
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
时间窗: 1 day
次要结局
- Aggregate mean difference in area under the curve (AUC) between methods(1 day)
- AUC of 0-1 hour (and by subtraction hours 1-5)(1 day)
- AUC of 0-2 hours (and by subtraction hours 2-5)(1 day)
- Time to 50% of Total AUC (or said another way, time to 50% exposure)(1 day)
- Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection(1 day)
- Aggregate mean difference in t1/2max between the methods(1 day visit)
- Fraction of subjects with difference in tmax between the methods of > 25%(1 day)
- Fraction of "dry" injections with no reflux of fluid from the injection site(1 day)
- Aggregate mean difference in Cmax between the methods(1 day)
- Difference in mean visual analog pain score between the two methods(1 day)
- Difference in mean visual analog pain score between insulin and glucagon with intradermal injection(1 day)
研究者
Steven J. Russell, MD, PhD
Associate Professor
Massachusetts General Hospital