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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

NCTNCT02411578 (opens ClinicalTrials.gov in a new tab)Other idT1DX Mini-dose Non-Severe

Overview

Status
Completed
Phase
Phase 2
Enrollment
26 participants (actual)
Sponsor
Jaeb Center for Health Research · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2015
Primary completion
Apr 2016
Completion
May 2016
First posted
8 Apr 2015 (estimated)
Last update posted
3 Mar 2020
Conditions
Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 2

    Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

    NCT02411578

    Sept 2015 to May 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • G-Pen Mini™ (glucagon injection)Drug
  • Glucose TabletsOther

Arms2

  • Experimental

    G-Pen Mini™ (glucagon injection)

    Participants 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.

  • Active comparator

    Glucose Tabs

    Participants 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 30 minutes

Secondary outcomes(14)
  1. Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level

    Time frame · 60 Minutes

    Registry description

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

  2. CGM Maximum Glucose, Event Level

    Time frame · 60 Minutes

    Registry description

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

  3. CGM Mean Glucose, Event Level

    Time frame · 60 Minutes

    Registry description

    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

  4. CGM Time in Range, Event Level

    Time frame · 60 Minutes

    Registry description

    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

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

    Time frame · 60 Minutes

    Registry description

    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

  6. CGM Minimum Glucose, Event Level

    Time frame · 120 Minutes

    Registry description

    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

  7. CGM Maximum Glucose, Event Level

    Time frame · 120 Minutes

    Registry description

    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

  8. CGM Mean Glucose, Event Level

    Time frame · 120 Minutes

    Registry description

    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

  9. CGM Time in Range, Event Level

    Time frame · 120 Minutes

    Registry description

    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

  10. CGM Time Below 70 mg/dL

    Time frame · 120 Minutes

    Registry description

    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

  11. CGM Mean Glucose

    Time frame · 3 weeks

    Registry description

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

  12. CGM Time in Range

    Time frame · 3 weeks

    Registry description

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

  13. CGM Time Below 70

    Time frame · 3 weeks

    Registry description

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

  14. CGM Coefficient of Variation

    Time frame · 3 weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of units· 30 minutes

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

GroupValue (Hypoglycemic Events)
G-Pen Mini™ (Glucagon Injection)58
Glucose Tabs53
Secondary and other outcome results(7)
Secondary outcomeMedian· 60 Minutes

Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level

GroupValue (mg/dL)
G-Pen Mini™ (Glucagon Injection)59
Glucose Tabs56
Secondary outcomeMedian· 60 Minutes

CGM Maximum Glucose, Event Level

GroupValue (mg/dL)
G-Pen Mini™ (Glucagon Injection)102
Glucose Tabs116
Secondary outcomeMedian· 60 Minutes

CGM Mean Glucose, Event Level

GroupValue (mg/dL)
G-Pen Mini™ (Glucagon Injection)79
Glucose Tabs87
Secondary outcomeMedian· 60 Minutes

CGM Time in Range, Event Level

GroupValue (percentage of time)
G-Pen Mini™ (Glucagon Injection)62
Glucose Tabs67
Secondary outcomeMedian· 60 Minutes

CGM Time Below 70 mg/dL, Event Level

GroupValue (percentage of time)
G-Pen Mini™ (Glucagon Injection)35
Glucose Tabs33
Secondary outcomeMedian· 120 Minutes

CGM Minimum Glucose, Event Level

GroupValue (mg/dL)
G-Pen Mini™ (Glucagon Injection)57
Glucose Tabs56
Secondary outcomeMedian· 120 Minutes

CGM Maximum Glucose, Event Level

GroupValue (mg/dL)
G-Pen Mini™ (Glucagon Injection)122
Glucose Tabs139

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
G-Pen Mini™ (Glucagon Injection)Participants treat non-severe hypoglycemic events with glucagon.0 / 200 / 202 / 20
Glucose TabsParticipants treat non-severe hypoglycemic events with glucose tabs.0 / 200 / 201 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2001

Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes.

Haymond et al. 2001Diabetes carecited by 71

PMID 11315823DOI 10.2337/diacare.24.4.643PUB-11315823

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHaymond 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. PMID 28591776

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin 2. Age: 18.0 to \< 65.0 years 3. Duration of T1D: ≥2.0 years 4. Body mass index 20.0 to \<35.0 kg/m2 and weight 110 to \<250 lbs 5. HbA1c \<8.5% (point of care or local lab, within past month) 6. 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) 7. Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study 8. 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 9. 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) 10. 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 11. Willing to adhere to the protocol requirements for the duration of the study 12. Participant has a smart phone available and is able to use it daily 13. Must be enrolled in the T1D Exchange clinic registry or willing to join the clinic registry Exclusion Criteria: 1. More than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment) 2. 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) 3. 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. 4. Known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance 5. 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 6. Use of non-insulin anti-diabetic medications 7. Use of daily systemic beta-blocker 8. Use of beta-adrenergic agonists, theophylline (or other methylxanthines) 9. Use of 1st generation anticholinergic drugs (such as Brompheniramine, Chlorpheniramine, Dimenhydrinate, Diphenhydramine, and Doxylamine) 10. Use of systemic corticosteroids 11. History of hypersensitivity to glucagon or any related product or excipient or severe hypersensitivity reactions (such as angioedema) to any drugs 12. History of epilepsy or seizure disorder 13. Uncontrolled hypertension, \>160 mmHg systolic or \>100 mmHg diastolic 14. 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 \[i.e. 7 METs x 60 minutes x 5 days a week, where 7 METs is equivalent to jogging\]) 15. Currently following a very low calorie or other weight-loss diet 16. 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

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