Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes
This study is currently recruiting participants.
Verified September 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01684956
First received: August 23, 2012
Last updated: September 12, 2012
Last verified: September 2012
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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: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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 two years
- 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).
- Body mass index (BMI) between 20 and 35.
- Total daily dose (TDD) of insulin that is less than 1 U/kg.
- Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 5 units of rapid acting insulin
Exclusion Criteria:
- Unable to provide informed consent
- Unable to comply with study procedures
- Inadequate venous access as determined by study nurse or physician at time of screening
- Pregnancy
- History of gastric banding, gastric bypass, or other gastrointestinal condition that may prevent a subject from consuming a normal sized meal
- Hemoglobin less than 12
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684956
Contacts
| Contact: Mallory A HIllard, BA | 617-643-2019 | kgrennan@partners.org |
| Contact: Kerry B Grennan, NP | 617-724-7700 | mahillard@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Steven J Russell, MD PhD 617-726-8722 SJRUSSELL@PARTNERS.ORG | |
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: | September 12, 2012 |
| 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 May 16, 2013