NCT01684956

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

August 23, 2012

Last Update Submit

September 6, 2016

Conditions

Type 1 Diabetes

Keywords

intradermalpharmacokineticsmicroneedleinsulinglucagon

Outcome Measures

Primary Outcomes (1)

  • Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)

    1 day

Secondary Outcomes (11)

  • Aggregate mean difference in t1/2max between the methods

    1 day visit

  • Aggregate mean difference in Cmax between the methods

    1 day

  • Aggregate mean difference in area under the curve (AUC) between methods

    1 day

  • AUC of 0-1 hour (and by subtraction hours 1-5)

    1 day

  • AUC of 0-2 hours (and by subtraction hours 2-5)

    1 day

  • +6 more secondary outcomes

Study Arms (2)

Intradermal first

EXPERIMENTAL

Intradermal injection experiment first, followed by subcutaneous injection experiment

Procedure: Intradermal injectionProcedure: Subcutaneous injection

Subcutaneous first

EXPERIMENTAL

Subcutaneous injection experiment first, followed by intradermal injection experiment

Procedure: Intradermal injectionProcedure: Subcutaneous injection

Interventions

Intradermal injectionPROCEDURE
Intradermal firstSubcutaneous first
Subcutaneous injectionPROCEDURE
Intradermal firstSubcutaneous first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Interventions

Injections, IntradermalInjections, Subcutaneous

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Steven J Russell, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 13, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

US(1)