Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes

Status unconfirmed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT01684956

Run by

Massachusetts General Hospital

People needed

20

Starts

2012-08-01

Expected to finish

2017-12-01

Last updated by the study team

2016-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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