Phase 2
N=19
PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT02081001 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early) — 17.2; 21.9; 21.3; 7.6 minutes — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Novo Nordisk GlucaGen® (Drug); G-Pump™ (glucagon infusion) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xeris Pharmaceuticals
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early) |
17.2; 21.9; 21.3; 7.6; 14.5; 22.8 | 0.23 |
| PRIMARY Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early) |
12.2; 12.4; 13.9; 7.6; 10.5; 11.0 | 0.23 |
| SECONDARY Glucagon Cmax |
168.1; 328.2; 440.6; 140.2; 229.3; 446.9 | 0.15 |
| SECONDARY Glucose Cmax |
177.6; 198.8; 212.6; 162.0; 183.3; 200.6 | 0.09 |
| SECONDARY Glucagon Tmax |
24.5; 27.3; 31.9; 23.3; 23.9; 23.9 | 0.70 |
| SECONDARY Glucose Tmax |
38.2; 49.5; 49.4; 25.9; 31.2; 52.8 | 0.16 |
| SECONDARY Glucagon AUC |
12104; 21177; 27595; 11070; 15781; 27355 | 0.61 |
| SECONDARY Glucose AUC |
22296; 26251; 27360; 21005; 24079; 25845 | 0.19 |
| SECONDARY Infusion Site Discomfort Score at 10 Minutes |
7.8; 18.9; 22.7; 2.2; 0.3; 0.3 | 0.24 |
| SECONDARY Infusion Site Discomfort Score at 30 Minutes |
1.9; 1.5; 3.8; 0; 0.7; 0.3 | 0.22 |
Summary
The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
Eligibility Criteria
Inclusion Criteria
- Males or females diagnosed with type 1 diabetes mellitus for at least 24 months
- Current usage of subcutaneous insulin pump treatment
- Age 18-65 years
- C-peptide level 10.0%
- Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)
- Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum bilirubin of over 2.0.
- Hematocrit of less than or equal to 34%
- Congestive heart failure, NYHA class II, III or IV
- History of coronary artery disease
- Active foot ulceration
- History of a cerebrovascular accident
- Active alcohol abuse or substance abuse
- Active malignancy, except basal cell or squamous cell skin cancers
- Major surgical operation within 30 days prior to screening
- Seizure disorder
- Current administration of oral or parenteral corticosteroids
- Use of an investigational drug within 30 days prior to screening
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000
- Proliferative or severe non-proliferative retinopathy
- Gastroparesis
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
- Insulinoma
- Allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products.
- Glycogen storage disease
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen
- Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening.
- Any reason the principal investigator deems exclusionary
Data sourced from ClinicalTrials.gov (NCT02081001). 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.