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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
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 moreTrial 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
2,943 Previous Clinical Trials
13,200,969 Total Patients Enrolled
Steven J Russell, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
16 Previous Clinical Trials
321 Total Patients Enrolled
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