Phase 2 N=16 Randomized Single-blind Prevention

The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT02660242 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Glycemic Response During Exercise and Early Recovery — 86; 85; 174; 161 mg/dL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: G-Pen Mini™ (glucagon injection) (Drug); Glucose Tabs (Other); Basal Insulin Reduction (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Jaeb Center for Health Research
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Glycemic Response During Exercise and Early Recovery	86; 85; 174; 161; 90; 92	<0.001 sig
SECONDARY Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery	6; 5; 0; 0	0.99
SECONDARY Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery	0; 0; 5; 1	0.15
SECONDARY Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose	45; 44; 49; 51	0.99
SECONDARY CGM Metrics During Late Recovery - Peak Glucose	241; 239; 267; 269	0.43
SECONDARY CGM Metrics During Late Recovery - Mean Glucose	129; 139; 130; 147	0.16
SECONDARY CGM Metrics During Late Recovery - Coefficient of Variation	32; 35; 36; 33	0.69
SECONDARY CGM Metrics During Late Recovery - Time < 54 mg/dL	3; 3; 3; 2	0.67
SECONDARY CGM Metrics During Late Recovery - Time < 70 mg/dL	10; 8; 8; 6	0.84
SECONDARY CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)	73; 71; 69; 67	0.63
SECONDARY CGM Metrics During Late Recovery - Time > 180 mg/dL	16; 21; 23; 26	0.24
SECONDARY CGM Metrics During Late Recovery - Time > 250 mg/dL	1; 4; 9; 5	0.26

Summary

This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin
Age 18-<65 years
Duration of T1D ≥ 2 years
Random C-peptide < 0.6 ng/ml
Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to discontinue pump use during the study
Exercises regularly, i.e. ≥30 minutes moderate or more vigorous aerobic activity X ≥3 times/week
Body mass index (BMI) <30 kg/m2
Females must meet one of the following criteria:
Of childbearing potential and not currently pregnant or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study; 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
Must be enrolled in the T1D Exchange clinic registry or willing to join the registry

Exclusion Criteria

One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment)
Active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage in past 6 months) that could potentially be worsened by exercise protocol
Peripheral neuropathy with insensate feet
Cardiovascular autonomic neuropathy with inappropriate heart rate response to exercise
Use of non-insulin anti-diabetic medications
Use of beta-blockers
Use of agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives
Use of Pramlintide
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02660242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.