Type 1 DiabetesPhase 2NCT01684956
Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes
A Phase 2 study testing Intradermal injection and Subcutaneous injection in people with Type 1 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Intradermal injection and Subcutaneous injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Volunteers With Type 1 Diabetes
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Intradermal injection, Subcutaneous injection
- Keywords
- intradermal, pharmacokinetics, microneedle, insulin, glucagon
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injectionProcedure or surgery
Subcutaneous injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intradermal first | Experimental | Intradermal injection experiment first, followed by subcutaneous injection experiment Receives: Procedure: Intradermal injection; Procedure: Subcutaneous injection |
| Subcutaneous first | Experimental | Subcutaneous injection experiment first, followed by intradermal injection experiment Receives: Procedure: Intradermal injection; Procedure: Subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
Measured: 1 day
Secondary outcomes (11)
Aggregate mean difference in t1/2max between the methods
Measured: 1 day visit
Aggregate mean difference in Cmax between the methods
Measured: 1 day
Aggregate mean difference in area under the curve (AUC) between methods
Measured: 1 day
AUC of 0-1 hour (and by subtraction hours 1-5)
Measured: 1 day
AUC of 0-2 hours (and by subtraction hours 2-5)
Measured: 1 day
Time to 50% of Total AUC (or said another way, time to 50% exposure)
Measured: 1 day
Fraction of subjects with difference in tmax between the methods of > 25%
Measured: 1 day
Fraction of "dry" injections with no reflux of fluid from the injection site
Measured: 1 day
Difference in mean visual analog pain score between the two methods
Measured: 1 day
Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection
Measured: 1 day
Difference in mean visual analog pain score between insulin and glucagon with intradermal injection
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684956
- Sponsor's protocol ID
- 2012P001098
- Status last verified
- Sep 2016
- First submitted
- 23 Aug 2012
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Volunteers With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01684956
- Acronym / sponsor ID
- 2012P001098
- Conditions
- Type 1 Diabetes
- Keywords
- intradermal, pharmacokinetics, microneedle, insulin, glucagon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal first | Experimental | Procedure: Intradermal injection, Procedure: Subcutaneous injectionIntradermal injection experiment first, followed by subcutaneous injection experiment |
| Subcutaneous first | Experimental | Procedure: Intradermal injection, Procedure: Subcutaneous injectionSubcutaneous injection experiment first, followed by intradermal injection experiment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal injection | Procedure or surgery | Intradermal first, Subcutaneous first |
| Subcutaneous injection | Procedure or surgery | Intradermal first, Subcutaneous first |
Primary outcome
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately)
Time frame: 1 day
11 secondary outcomes
Aggregate mean difference in t1/2max between the methods
Time frame: 1 day visit
Aggregate mean difference in Cmax between the methods
Time frame: 1 day
Aggregate mean difference in area under the curve (AUC) between methods
Time frame: 1 day
AUC of 0-1 hour (and by subtraction hours 1-5)
Time frame: 1 day
AUC of 0-2 hours (and by subtraction hours 2-5)
Time frame: 1 day
Time to 50% of Total AUC (or said another way, time to 50% exposure)
Time frame: 1 day
Fraction of subjects with difference in tmax between the methods of > 25%
Time frame: 1 day
Fraction of "dry" injections with no reflux of fluid from the injection site
Time frame: 1 day
Difference in mean visual analog pain score between the two methods
Time frame: 1 day
Difference in mean visual analog pain score between insulin and glucagon with subcutaneous injection
Time frame: 1 day
Difference in mean visual analog pain score between insulin and glucagon with intradermal injection
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Russell, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intradermal injection and Subcutaneous injection in people with Type 1 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregate mean difference in tmax between the delivery methods (the insulin and glucagon data will be evaluated separately) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.