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Diabetes Mellitus, Type 1Phase 2NCT02411578

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

A Phase 2 study testing G-Pen Mini™ (glucagon injection) and Glucose Tablets in people with Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 5 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 is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D). Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
G-Pen Mini™ (glucagon injection) and Glucose Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
5 sitesUnited States
Study dates
Sep 2015to May 2016
Phase
Phase 2
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin
  • Age: 18.0 to < 65.0 years
  • Duration of T1D: ≥2.0 years
  • Body mass index 20.0 to <35.0 kg/m2 and weight 110 to <250 lbs
  • HbA1c <8.5% (point of care or local lab, within past month)
  • Using continuous subcutaneous insulin infusion (CSII) therapy (i.e., insulin pump) for at least 3 months, with no plans to discontinue use during the study (and no use of active low glucose suspend feature within the last 4 weeks)
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  • Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study
  • Continuous glucose monitor glucose level <70 mg/dl during daytime hours (e.g., 8am - 10pm) on at least 7 of the past 28 days (a modification can be made for participants with non-traditional waking hours) evaluated from downloaded CGM data
  • Females must meet one of the following criteria:
  • Of childbearing potential and not currently pregnant (negative pregnancy test) or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening visit until study completion); or
  • Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
  • In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
  • Willing to adhere to the protocol requirements for the duration of the study
  • Participant has a smart phone available and is able to use it daily
  • Must be enrolled in the T1D Exchange clinic registry or willing to join the clinic registry

Who cannot join

  • More than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment)
  • More than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an episode diagnosed as diabetic ketoacidosis that required treatment in an emergency department or hospitalization)
  • Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical condition which, in the judgment of the investigator, could potentiate or predispose to undesired effects or could interfere with the absorption, distribution, metabolism, or excretion of glucagon or ability to respond appropriately to mild to moderate hypoglycemia.
  • Known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance
  • Males with alcohol use in excess of 3 or more drinks per day, on average and females with alcohol use in excess of 2 or more drinks per day, on average
  • Use of non-insulin anti-diabetic medications
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  • Use of daily systemic beta-blocker
  • Use of beta-adrenergic agonists, theophylline (or other methylxanthines)
  • Use of 1st generation anticholinergic drugs (such as Brompheniramine, Chlorpheniramine, Dimenhydrinate, Diphenhydramine, and Doxylamine)
  • Use of systemic corticosteroids
  • History of hypersensitivity to glucagon or any related product or excipient or severe hypersensitivity reactions (such as angioedema) to any drugs
  • History of epilepsy or seizure disorder
  • Uncontrolled hypertension, >160 mmHg systolic or >100 mmHg diastolic
  • Currently a high endurance exerciser or plans to perform high endurance exercise during study (from screening visit until study completion)
  • High endurance exerciser defined as a person who regularly competes in running, cycling, rowing, swimming or any other endurance-based activity for the purpose of competition (>2100 metabolic equivalent of task (MET) minutes per week [i.e. 7 METs x 60 minutes x 5 days a week, where 7 METs is equivalent to jogging])
  • Currently following a very low calorie or other weight-loss diet
  • Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Colorado/Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Yale University of Medicine

    New Haven, Connecticut, 06510

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Mini-Dose Glucagon for Adults With Type 1 Diabetes: A Study to Assess the Efficacy and Safety of Mini-dose Glucagon for Treatment of Non-severe Hypoglycemia in Adults With Type 1 Diabetes

The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).

Read the detailed description

There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2) Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension Phase.

  1. Run-in Phase: Prior to commencing the crossover trial, study enrollment will begin with a 2 week run-in phase to assess hypoglycemia eligibility and compliance.
  2. Crossover Trial Phase: The Crossover Trial Phase will consist of two (3-week) periods. The Crossover Trial Phase will include up to 24 participants who complete these study periods. Participants who do not complete both periods or who do not have at least one event during both periods may be replaced. During the Crossover Trial Phase participants will be randomized into two groups: (1) Group A will use mini-dose glucagon in period 1 and oral glucose tablets in period 2 and (2) Group B will use oral glucose tablets in period 1 and mini-dose glucagon in period 2. Each group with follow the applicable treatment arm according to their randomized group.
  3. Extension Phase:

The Post-Crossover Trial phase will commence upon completion of the second 3-week period of the Crossover Trial Phase. Participants will have a 3 week phase during which time they will decide whether to use mini-dose glucagon or glucose tablets to treat each non-severe hypoglycemic event or to prevent hypoglycemia.

Being tested
G-Pen Mini™ (glucagon injection), Glucose Tablets
Keywords
T1D, Type 1 diabetes, Mini-dose glucagon, adults, non-severe hypoglycemia
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.

  • G-Pen Mini™ (glucagon injection)Drug

    Also called mini-dose glucagon

    1st BG check, 1st treatment

    1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon
    2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon

    15 min later, 2nd BG check, 2nd treatment

    1. BG is 60-69 mg/dl, no treatment
    2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon
    3. BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon

    30 minutes later, 3rd BG check, 3rd treatment

    1. BG is >=70, no treatment
    2. BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (150 µg of glucagon per syringe)

  • Glucose TabletsOther

    Also called over-the-counter oral glucose tablets; glucose tabs

    1st BG check, 1st treatment

    1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
    2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates

    15 min later, 2nd BG check, 2nd treatment

    1. BG is 60-69 mg/dl, no treatment
    2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
    3. BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon

    30 minutes later, 3rd BG check, 3rd treatment

    1. BG is >=70, no treatment
    2. BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (5 grams of fast-acting carbohydrates (D-Glucose) per tablet)
Study groups in NCT02411578
Study groupRoleWhat they receive
G-Pen Mini™ (glucagon injection)ExperimentalParticipants are to check blood glucose (BG) with study meter once their continuous glucose monitor (CGM) reads <70 mg/dl or they experience symptoms. Participants will be instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
Receives: Drug: G-Pen Mini™ (glucagon injection)
Glucose TabsActive comparatorParticipants are to check their blood glucose (BG) with study meter once their continuous glucose meter reads <70 mg/dl or they experience symptoms. Participants will be instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). For every event, participant will check BG with meter 3 times and treat according to protocol instructions based on BG measurement.
Receives: Other: Glucose Tablets

What is being measured

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

  1. Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment

    Measured: 30 minutes

Secondary outcomes (14)

  1. Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level

    Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

    Measured: 60 Minutes

  2. CGM Maximum Glucose, Event Level

    Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

    Measured: 60 Minutes

  3. CGM Mean Glucose, Event Level

    Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

    Measured: 60 Minutes

  4. CGM Time in Range, Event Level

    Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

    Measured: 60 Minutes

  5. CGM Time Below 70 mg/dL, Event Level

    Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

    Measured: 60 Minutes

  6. CGM Minimum Glucose, Event Level

    Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

    Measured: 120 Minutes

  7. CGM Maximum Glucose, Event Level

    Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

    Measured: 120 Minutes

  8. CGM Mean Glucose, Event Level

    Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

    Measured: 120 Minutes

  9. CGM Time in Range, Event Level

    Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

    Measured: 120 Minutes

  10. CGM Time Below 70 mg/dL

    Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

    Measured: 120 Minutes

  11. CGM Mean Glucose

    Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period

    Measured: 3 weeks

  12. CGM Time in Range

    Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period

    Measured: 3 weeks

  13. CGM Time Below 70

    Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period

    Measured: 3 weeks

  14. CGM Coefficient of Variation

    Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period

    Measured: 3 weeks

Timeline

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

  1. First posted8 Apr 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2016
  4. Study completionMay 2016

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02411578
Sponsor's protocol ID
T1DX Mini-dose Non-Severe
Status last verified
Feb 2020
First submitted
27 Mar 2015
Last updated
3 Mar 2020
Data monitoring committee
No

Publications

  • Cryer PE. The barrier of hypoglycemia in diabetes. Diabetes. 2008 Dec;57(12):3169-76. doi: 10.2337/db08-1084. No abstract available.

    PubMed 19033403

  • Cryer PE. Hypoglycemia in type 1 diabetes mellitus. Endocrinol Metab Clin North Am. 2010 Sep;39(3):641-54. doi: 10.1016/j.ecl.2010.05.003.

    PubMed 20723825

  • Raju B, Arbelaez AM, Breckenridge SM, Cryer PE. Nocturnal hypoglycemia in type 1 diabetes: an assessment of preventive bedtime treatments. J Clin Endocrinol Metab. 2006 Jun;91(6):2087-92. doi: 10.1210/jc.2005-2798. Epub 2006 Feb 21.

    PubMed 16492699

  • Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8.

    PubMed 19429875

  • Haymond MW, Schreiner B. Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes. Diabetes Care. 2001 Apr;24(4):643-5. doi: 10.2337/diacare.24.4.643.

    PubMed 11315823

  • Hartley M, Thomsett MJ, Cotterill AM. Mini-dose glucagon rescue for mild hypoglycaemia in children with type 1 diabetes: the Brisbane experience. J Paediatr Child Health. 2006 Mar;42(3):108-11. doi: 10.1111/j.1440-1754.2006.00807.x.

    PubMed 16509909

  • Hasan KS, Kabbani M. Mini-dose glucagon is effective at diabetes camp. J Pediatr. 2004 Jun;144(6):834. No abstract available.

    PubMed 15212060

  • Haymond MW, DuBose SN, Rickels MR, Wolpert H, Shah VN, Sherr JL, Weinstock RS, Agarwal S, Verdejo AS, Cummins MJ, Newswanger B, Beck RW; T1D Exchange Mini-dose Glucagon Study Group. Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2994-3001. doi: 10.1210/jc.2017-00591.

    PubMed 28591776

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing G-Pen Mini™ (glucagon injection) and Glucose Tablets in people with Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 5 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 15 inclusion and 17 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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?

Yes. Results are posted in the registry (first posted 23 Oct 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?

Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment (time frame: 30 minutes). 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 NCT02411578, which also lists 8 linked publications.

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 3 Mar 2020.

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