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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01684956
First received: August 23, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Procedure: Intradermal injection
Procedure: Subcutaneous injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Volunteers With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aggregate mean difference in t1/2max between the methods [ Designated as safety issue: No ]
  • Aggregate mean difference in Cmax between the methods [ Designated as safety issue: No ]
  • Aggregate mean difference in area under the curve (AUC) between methods [ Designated as safety issue: No ]
  • AUC of 0-1 hour (and by subtraction hours 1-5) [ Designated as safety issue: No ]
  • AUC of 0-2 hours (and by subtraction hours 2-5) [ Designated as safety issue: No ]
  • Time to 50% of Total AUC (or said another way, time to 50% exposure) [ Designated as safety issue: No ]
  • Fraction of subjects with difference in tmax between the methods of > 25% [ Designated as safety issue: No ]
  • Fraction of "dry" injections with no reflux of fluid from the injection site [ Designated as safety issue: No ]
  • Difference in mean visual analog pain score between the two methods [ Designated as safety issue: No ]
  • Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection [ Designated as safety issue: No ]
  • Difference in mean visual analog pain score between insulin and glucagon with intradermal injection [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intradermal first
Intradermal injection experiment first, followed by subcutaneous injection experiment
Procedure: Intradermal injection Procedure: Subcutaneous injection
Experimental: Subcutaneous first
Subcutaneous injection experiment first, followed by intradermal injection experiment
Procedure: Intradermal injection Procedure: Subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684956

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Steven J. Russell, MD, PhD, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01684956     History of Changes
Other Study ID Numbers: 2012P001098
Study First Received: August 23, 2012
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
intradermal
pharmacokinetics
microneedle
insulin
glucagon

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Insulin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 08, 2014