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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01684956
• Other study ID #: 2012P001098
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 23, 2012
• Last updated: September 6, 2016
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Procedure:
• Intradermal injection

• Subcutaneous injection

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)		1 day	No
Secondary	Aggregate mean difference in t1/2max between the methods		1 day visit	No
Secondary	Aggregate mean difference in Cmax between the methods		1 day	No
Secondary	Aggregate mean difference in area under the curve (AUC) between methods		1 day	No
Secondary	AUC of 0-1 hour (and by subtraction hours 1-5)		1 day	No
Secondary	AUC of 0-2 hours (and by subtraction hours 2-5)		1 day	No
Secondary	Time to 50% of Total AUC (or said another way, time to 50% exposure)		1 day	No
Secondary	Fraction of subjects with difference in tmax between the methods of > 25%		1 day	No
Secondary	Fraction of "dry" injections with no reflux of fluid from the injection site		1 day	No
Secondary	Difference in mean visual analog pain score between the two methods		1 day	No
Secondary	Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection		1 day	No
Secondary	Difference in mean visual analog pain score between insulin and glucagon with intradermal injection		1 day	No