Phase 2
Completed N=48
Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D
Source: ClinicalTrials.gov NCT03841526 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise. — 0.12; 0.39; 0.16; 0.24 events/session — p=0.0002
Summary
This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel comparison with a third open-label arm in an outpatient setting. The purpose of the study is to evaluate the preliminary efficacy and safety of Glucagon Ready-to-Use [RTU] to prevent exercise-induced hypoglycemia (EIH) in adults with Type 1 diabetes mellitus (T1D), who perform regular, moderate-to-high intensity aerobic exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise. |
0.12; 0.39; 0.16; 0.24 | 0.0002 sig |
| PRIMARY Outpatient Phase: Mean Number of Hypoglycemic Events |
1.94; 8.43; 2.86; 4.3 | — |
| PRIMARY Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions |
15.69; 21.64; 17.36; 18.11 | — |
| SECONDARY CRC Phase: Interstitial Glucose Below Target Range |
4; 5; 9; 4; 5; 9 | 1.0000 |
| SECONDARY Outpatient Phase: Interstitial Glucose Levels Below Target Range |
14; 14; 12; 40; 14; 14 | 0.8590 |
| SECONDARY Outpatient Phase: Insulin Use Change From Baseline |
-2.80; 2.60; 0.10; -2.10; -7.60; -1.70 | — |
| SECONDARY Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline |
2.25; 2.17; 2.59; 0.01; -0.38; -0.34 | — |
| SECONDARY Outpatient Phase: HFS-II Overall Score Change From Baseline |
1.28; 1.16; 1.50; -0.19; -0.01; -0.03 | — |
| SECONDARY Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline |
3.23; 3.34; 3.20; 0.07; 0.17; 0.20 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin via continuous subcutaneous insulin infusion.
- Age 18 to 9.0% at Screening.
- Renal insufficiency (serum creatinine greater than 3 mg/dL (0.17 mmol/L)).
- Serum alanine aminotransferase or aspartate aminotransferase equal to or greater than 3 times the upper limit of normal.
- Hepatic synthetic insufficiency as defined as a serum albumin of less than 3 mg/dL (0.17 mmol/L); or serum bilirubin greater than 2 mg/dL (0.11 mmol/L).
- Hematocrit of less than or equal to 30%.
- Mean of triplicate blood pressure (BP) readings at Screening where systolic BP 150 mm Hg, or diastolic BP 100 mm Hg.
- Clinically significant electrocardiogram abnormalities.
- Use of > 2.0 U/kg total insulin dose per day.
- Inadequate bilateral venous access in both arms.
- Congestive heart failure, New York Heart Association class III or IV.
- Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers.
- Major surgical operation within 90 days prior to screening, or planned surgical operation during the study.
- History of seizure disorders.
- Bleeding disorder, treatment with warfarin or any anticoagulants, or platelet count below 50,000 mm3 at Screening.
- History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2, neurofibromatosis, or Von Hippel-Lindau disease).
- History of insulinoma.
- History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (dimethylsulfoxide, mannitol, & trehalose) in the investigational formulation.
- History of glycogen storage disease.
- Subject tests positive for human immunodeficiency virus, hepatitis C virus, or active hepatitis B virus infection at Screening.
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- Active substance or alcohol abuse, in the opinion of the investigator. Subjects reporting active marijuana use or testing positive for tetrahydrocannabinol via rapid urine test will be allowed to participate in the study at the discretion of the investigator.
- Participation in other studies involving administration of an investigational therapeutic agent (drug or device) within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study.
- Any reason the investigator deems exclusionary.
Data sourced from ClinicalTrials.gov (NCT03841526). 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. Informational only — not medical advice.