Pharmacokinetic Comparison of Intradermal Versus Sub-cuta... | NCT01684956

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

NCT01684956

Sponsor

Massachusetts General Hospital

Status

Unknown status

Last Update Posted

Sep 7, 2016Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Type 1 Diabetes

Interventions

Intradermal injection
Subcutaneous injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Aug 23, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intradermal first	Experimental	Intradermal injection experiment first, followed by subcutaneous injection experiment	Procedure: Intradermal injection Procedure: Subcutaneous injection
Subcutaneous first	Experimental	Subcutaneous injection experiment first, followed by intradermal injection experiment	Procedure: Intradermal injection Procedure: Subcutaneous injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intradermal injection	Procedure		Intradermal first Subcutaneous first
Subcutaneous injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)		1 day

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Oct 19, 2020
Reset	Nov 12, 2020
Release	Mar 28, 2022
Unrelease	Apr 1, 2022
Release	Apr 4, 2022
Reset	Oct 25, 2022
Release	Nov 10, 2022
Reset	Sep 14, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 19, 2020			Nov 12, 2020
Mar 28, 2022	Apr 1, 2022

ID	Term
D003922	Diabetes Mellitus, Type 1
D007333	Insulin Resistance

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D007271	Injections, Intradermal
D007279	Injections, Subcutaneous

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics