Clinical trial NCT01684956: Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes
Official title: Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Volunteers With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: intradermal
pharmacokinetics
microneedle
insulin
glucagon
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
timeFrame: 1 day
Secondary outcomes:
measure: Aggregate mean difference in t1/2max between the methods
timeFrame: 1 day visit
measure: Aggregate mean difference in Cmax between the methods
timeFrame: 1 day
measure: Aggregate mean difference in area under the curve (AUC) between methods
timeFrame: 1 day
measure: AUC of 0-1 hour (and by subtraction hours 1-5)
timeFrame: 1 day
measure: AUC of 0-2 hours (and by subtraction hours 2-5)
timeFrame: 1 day
measure: Time to 50% of Total AUC (or said another way, time to 50% exposure)
timeFrame: 1 day
measure: Fraction of subjects with difference in tmax between the methods of > 25%
timeFrame: 1 day
measure: Fraction of "dry" injections with no reflux of fluid from the injection site
timeFrame: 1 day
measure: Difference in mean visual analog pain score between the two methods
timeFrame: 1 day
measure: Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection
timeFrame: 1 day
measure: Difference in mean visual analog pain score between insulin and glucagon with intradermal injection
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Russell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: