Diabetes Mellitus, Type 1Phase 2/3NCT01997411

Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

A Phase 2/3 study testing Nasal Glucagon and Intramuscular Glucagon in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to assess how glucagon administered nasally, using a nasal dosing delivery device, works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given nasally was evaluated. Read more about this study

Who is it for?: Ages 4 to 16 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Nasal Glucagon and Intramuscular Glucagon
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 7 sitesUnited States
Study dates: Nov 2013to Jan 2015
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

To be eligible, the following inclusion criteria were met:
History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months
At least 4 years of age and less than 17 years
Females must have met one of the following criteria:
Of childbearing potential but agreed to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening until study completion)
Of non-childbearing potential, defined as a female who had a hysterectomy or tubal ligation, was clinically considered infertile or had not yet reached menarche
In good general health with no conditions that could have influenced the outcome of the trial, and in the judgment of the Investigator was a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
Willingness to adhere to the study requirements

Who cannot join

An individual was not eligible if any of the following exclusion criteria were present:
Females who were pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or were lactating
History of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could have interfered with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects
History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to enrolling in the study

Show all 10Show fewer

Use of daily systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
History of epilepsy or seizure disorder
Use of an Investigational Product in another clinical trial within the past 30 days
Blood donation in 3 months prior to first glucagon dosing

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
UPA Buffalo
Buffalo, New York, 14222
University of Florida
Gainesville, Florida, 32605
Riley Hospital for Children Indiana University Health
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Minnesota
Minneapolis, Minnesota, 55454
Yale University
New Haven, Connecticut, 06520

Other trials in United States

About this study

Read the detailed description

This study was conducted to permit determination of appropriate dose level(s) for pediatric use based on the safety observations and results of glucagon and glucose assays.

Each participant 12 to less than 17 years of age underwent two visits in random order and received glucagon nasal powder once and commercially available glucagon (GlucaGen, Novo Nordisk) by intramuscular (IM) injection once. Participants 4 to less than 12 years were randomly assigned to have either 1 visit with commercially available glucagon (GlucaGen, Novo Nordisk) by IM injection OR to have 2 visits with a 2.0 milligram (mg) dose of glucagon nasal powder administered during one visit and a 3.0 mg dose of glucagon nasal powder administered during the other visit. For those randomized to complete two research dosing visits, the dose of glucagon nasal powder given during each visit was masked to the participant and study personnel.

Glucagon was administered after glucose was lowered to <80 mg/dL using insulin if necessary on the dosing day. Participants were treated with either glucagon given nasally (either 2.0 mg or 3.0 mg for participants 4 to less than 12 years of age or 3.0 mg for those 12 to less than 17 years of age) or by intramuscular (IM) injection (1 mg for those 55 pounds [lbs] or more and 0.5 mg for those weighing less than 55 lbs) in the quadriceps muscle of the leg.

Blood glucose levels and adverse events were carefully monitored for 90 minutes post-dosing. After a wash-out period of 7 days or more, participants 12 to less than 17 years of age returned to the clinic and the procedure was repeated with each participant crossed over to the other treatment. Participants 4 to less than 12 years assigned to have 2 dosing visits returned to clinic for repeated procedures and received alternate dose of nasal glucagon (NG). Participants 4 to less than 12 years assigned to a single dosing visit did not return for a second dosing visit.

Conditions: Diabetes Mellitus, Type 1
Being tested: Nasal Glucagon, Intramuscular Glucagon
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasal GlucagonDrug
Also called AMG504-1, LY900018
Intramuscular GlucagonDrug
Also called GlucaGen HypoKit

Study groups in NCT01997411
Study group	Role	What they receive
Nasal Glucagon (NG)	Experimental	Nasal glucagon (NG) doses of 2.0 mg and 3.0 mg for participants 4 to less than 12 years of age and 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation. Receives: Drug: Nasal Glucagon
Intramuscular (IM) Glucagon	Active comparator	Participants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg Receives: Drug: Intramuscular Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Change From Baseline Concentration (Cmax) of Glucagon
Measured: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Measured: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon
Measured: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Measured: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Measured: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes
Measured: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Secondary outcomes (3)

Nasal and Non-nasal Effects/Symptoms
Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed prior to administering glucagon and at 15, 30, 60 and 90 minutes following administration of glucagon. This was done via the "Nasal Non-nasal Score Questionnaire". Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each participant and reporting the median/IQR across participants).
Measured: Pre-dose;15, 30, 60 and 90 minutes following glucagon administration
Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes
Measured: Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes
Time (in minutes) when all participants experienced a rise in glucose >=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort.
Measured: Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Jan 2015

First posted28 Nov 2013 (estimated)
Study startNov 2013
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01997411
Sponsor's protocol ID: 16418
Other IDs: I8R-MC-IGBB, INGluc002, AMG103
Status last verified: Aug 2018
First submitted: 22 Nov 2013
Last updated: 29 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sherr JL, Ruedy KJ, Foster NC, Piche CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):555-62. doi: 10.2337/dc15-1606. Epub 2016 Feb 16.
PubMed 26884472

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes
ClinicalTrials.gov ID: NCT01997411
Acronym / sponsor ID: 16418
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Jaeb Center for Health Research, Locemia Solutions ULC
Study start: Nov 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 28 Nov 2013 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study was conducted to permit determination of appropriate dose level(s) for pediatric use based on the safety observations and results of glucagon and glucose assays.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nasal Glucagon (NG)	Experimental	Drug: Nasal GlucagonNasal glucagon (NG) doses of 2.0 mg and 3.0 mg for participants 4 to less than 12 years of age and 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.
Intramuscular (IM) Glucagon	Active comparator	Drug: Intramuscular GlucagonParticipants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg

Who may qualify

Ages: 4 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months
At least 4 years of age and less than 17 years
Females must have met one of the following criteria:
In good general health with no conditions that could have influenced the outcome of the trial, and in the judgment of the Investigator was a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
Willingness to adhere to the study requirements

Key exclusion criteria (10 listed)

Females who were pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or were lactating
History of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could have interfered with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects
History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to enrolling in the study

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
Nasal GlucagonAlso: AMG504-1, LY900018	Drug	Nasal Glucagon (NG)
Intramuscular GlucagonAlso: GlucaGen HypoKit	Drug	Intramuscular (IM) Glucagon

Primary outcome

Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon
Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes
Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

3 secondary outcomes

Nasal and Non-nasal Effects/Symptoms
Time frame: Pre-dose;15, 30, 60 and 90 minutes following glucagon administration
Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes
Time frame: Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes
Time frame: Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration

Results and safety

Results posted to the registry on 6 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
4 to<8 Years Old Intramuscular (IM) Glucagon Visit	6	6
4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit	6	6
4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit	6	6
8 to <12 Years Old Intramuscular Glucagon Visit	6	6
8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit	6	6
8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit	6	5
12 to <17 Years Old NG 1st Visit/IM Glucagon 2nd Visit	6	6
12 to <17 Years Old IM Glucagon 1st Visit/NG 2nd Visit	6	6

Primary outcome: Maximum Change From Baseline Concentration (Cmax) of Glucagon

Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration. Mean (Standard Deviation). Unit: picograms per millilitre (pg/mL)

Measure	4 to<8 Years Old IM Glucagon Visit n = 6	4 to<8 Years Old NG Visit 2.0 mg n = 11	4 to<8 Years Old NG Visit 3.0 mg n = 12	8 to <12 Years Old IM Glucagon Visit n = 6	8 to<12 Years Old NG Visit 2.0 mg n = 11	8 to<12 Years Old NG Visit 3.0 mg n = 12	12 to <17 Years Old IM Glucagon Visit n = 12	12 to<17 Years Old NG Visit 3.0 mg n = 12
Value	6290.33 (2045.96)	3463.55 (1760.28)	3958.58 (2438.60)	4743.00 (3094.61)	2776.27 (979.28)	5664.33 (2114.69)	4277.25 (3774.77)	3103.25 (2302.61)

Population analysed: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.

Primary outcome: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration. Median (Full Range). Unit: hours (hr)

Measure	4 to<8 Years Old IM Glucagon Visit n = 6	4 to<8 Years Old NG Visit 2.0 mg n = 11	4 to<8 Years Old NG Visit 3.0 mg n = 12	8 to <12 Years Old IM Glucagon Visit n = 6	8 to<12 Years Old NG Visit 2.0 mg n = 11	8 to<12 Years Old NG Visit 3.0 mg n = 12	12 to <17 Years Old IM Glucagon Visit n = 12	12 to<17 Years Old NG Visit 3.0 mg n = 12
Value	0.29 (0.08 to 0.50)	0.25 (0.17 to 0.33)	0.29 (0.17 to 1.00)	0.29 (0.08 to 0.50)	0.25 (0.17 to 0.33)	0.25 (0.17 to 0.50)	0.29 (0.08 to 0.50)	0.33 (0.25 to 0.50)

Primary outcome: Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration. Mean (Standard Deviation). Unit: hour*picogram per millilitre (hr*pg/mL)

Measure	4 to<8 Years Old IM Glucagon Visit n = 6	4 to<8 Years Old NG Visit 2.0 mg n = 11	4 to<8 Years Old NG Visit 3.0 mg n = 12	8 to <12 Years Old IM Glucagon Visit n = 6	8 to<12 Years Old NG Visit 2.0 mg n = 11	8 to<12 Years Old NG Visit 3.0 mg n = 12	12 to <17 Years Old IM Glucagon Visit n = 12	12 to<17 Years Old NG Visit 3.0 mg n = 12
Value	4078.68 (2078.89)	1744.36 (978.81)	2472.40 (1435.45)	3635.77 (2069.11)	1506.23 (541.57)	2939.31 (1042.03)	3110.22 (2848.75)	1999.69 (1329.44)

Primary outcome: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

Time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration. Mean (Standard Deviation). Unit: mg/dL

Measure	4 to<8 Years Old IM Glucagon Visit n = 6	4 to<8 Years Old NG Visit 2.0 mg n = 11	4 to<8 Years Old NG Visit 3.0 mg n = 12	8 to <12 Years Old IM Glucagon Visit n = 6	8 to<12 Years Old NG Visit 2.0 mg n = 11	8 to<12 Years Old NG Visit 3.0 mg n = 12	12 to <17 Years Old IM Glucagon Visit n = 12	12 to<17 Years Old NG Visit 3.0 mg n = 12
Value	138.17 (26.57)	118.18 (46.46)	137.50 (42.14)	130.50 (21.81)	125.09 (23.81)	132.82 (30.59)	123.17 (29.58)	102.33 (25.63)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, up to 69 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4 to<8 Years Old IM Glucagon Visit	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
4 to<8 Years Old NG Visit 2.0 mg	0 of 12 (0%)	6 of 12 (50%)	Not reported
4 to<8 Years Old NG Visit 3.0 mg	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
8 to <12 Years Old IM Glucagon Visit	0 of 6 (0%)	6 of 6 (100%)	Not reported
8 to<12 Years Old NG Visit 2.0 mg	0 of 11 (0%)	5 of 11 (45.5%)	Not reported
8 to<12 Years Old NG Visit 3.0 mg	0 of 12 (0%)	6 of 12 (50%)	Not reported
12 to <17 Years Old IM Glucagon Visit	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
12 to<17 Years Old NG Visit 3.0 mg	0 of 12 (0%)	9 of 12 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26884472Sherr JL, Ruedy KJ, Foster NC, Piche CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):555-62. doi: 10.2337/dc15-1606. Epub 2016 Feb 16.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nasal Glucagon and Intramuscular Glucagon in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 7 sites 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Change From Baseline Concentration (Cmax) of Glucagon (time frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01997411, which also lists 1 linked publication.

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 29 Aug 2018.