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Glucagon

Intradermal first for Type 1 Diabetes

Phase 2
Waitlist Available
Led By Steven J Russell, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study 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.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
Secondary outcome measures
AUC of 0-1 hour (and by subtraction hours 1-5)
AUC of 0-2 hours (and by subtraction hours 2-5)
Aggregate mean difference in Cmax between the methods
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subcutaneous firstExperimental Treatment2 Interventions
Subcutaneous injection experiment first, followed by intradermal injection experiment
Group II: Intradermal firstExperimental Treatment2 Interventions
Intradermal injection experiment first, followed by subcutaneous injection experiment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intradermal injection
2020
Completed Early Phase 1
~40
Subcutaneous injection
2015
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,335 Total Patients Enrolled
Steven J Russell, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
16 Previous Clinical Trials
321 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes
Steven J. Russell, MD, PhD 2012. "Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01684956.
All > Liver Fibrosis > Type 1 Diabetes
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