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A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Very Low Dose-Glucagon in Subjects With Type 1 Diabetes Mellitus

Information source: DiObex
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: very low dose (VLD) glucagon (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: DiObex

Official(s) and/or principal investigator(s):
Steven Edelman, MD, Principal Investigator, Affiliation: University of California, San Diego


The purpose of this study is to identify the safest dose of very low dose glucagon to prevent hypoglycemia in patients with Type I diabetes who use insulin pumps and to measure the the amount of glucagon in the blood and see how the body responds to the glucagon.

Clinical Details

Official title: A Phase 1b, Single-Blind Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Three Separate Dose Levels of Very Low Dose-Glucagon Administered Subcutaneously Overnight for 6, 9 or 12 Hours in Subjects With Type 1 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: 1) Evaluate the safety and tolerability of VLD-glucagon in doses of 2, 4 and 8 ng/kg/minute when infused overnight 2) Evaluate the PK profile in plasma of VLD-glucagon 3) Evaluate the pharmacodynamic activity of these doses by measuring glucose levels

Secondary outcome: Compare the number of times and amount of time subjects have glucose levels < 70 mg/dL when treated with VLD-glucagon vs. the control infusion

Detailed description: Glucagon is currently used to treat severe hypoglycemia. DiObex believes that glucagon replacement therapy with very low doses of glucagon may prevent hypoglycemia without compromising effective glycemic control by insulin. In this study very low doses of glucagon will administered to Type I diabetics who use insulin pumps. The glucagon will be administered subcutaneously overnight for 6, 9 or 12 hours to see if the number of mild or impending hypoglycemia events can be safely decreased. Three different doses of glucagon will be compared to a control infusion.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria: 1. Males or females, 18 to 55 years of age, requiring daily insulin for the management of type 1 diabetes mellitus for >10 years 2. On a stable basal insulin regimen using CSII therapy (“stable” defined as total daily dose of insulin not changed by more than ± 20% for 2 months prior to screening) 3. Glycosylated hemoglobin (HbA1c) ≤8. 0% 4. Total daily insulin requirement of ≤1 unit/kg of body weight 5. Fasting C-peptide level of <1. 0 ng/mL (<330 pmol/L) (may be done at screening or may be taken from subject’s medical record if performed within the past 12 months) 6. Body mass index (BMI) ≤25. 5 kg/m2 and body weight over past 6 months within ± 5% 7. Hemoglobin, hematocrit, and platelets within normal limits; no clinically significant abnormality of white blood cells (WBC) or differential 8. Serum chemistry results within normal limits except for liver enzymes [aspartate transaminase (AST) and alanine transaminase (ALT)] which must be within 2. 5 times upper limit of normal (ULN) and creatinine which must be <1. 6 mg/dL 9. Normal thyroid stimulating hormone 10. No history of HIV infection and negative results for hepatitis B and C 11. Negative serum pregnancy test, non-lactating, and using adequate contraception, if female and of child bearing potential (intact uterus and pre-menopausal) 12. Medications for the treatment of high blood pressure and/or dyslipidemia are allowed if regimen stable for 2 months prior to screening 13. Medically stable as determined by history and physical examination, including vital signs 14. Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality 15. Willing and able to give written informed consent Exclusion Criteria: 1. Participation in a clinical trial with or use of an investigational agent within 30 days of Study Visit 1. 2. History of atherosclerosis including coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident, or transient ischemic attacks 3. History or symptoms of pheochromocytoma 4. History of any malignancy within 3 years except for basal cell skin cancer 5. Active infection, drug or alcohol abuse, eating disorder, or psychiatric disorder 6. Concomitant medications: systemic or potent topical steroids or medications that may affect blood glucose, e. g., sulfonylureas, alpha-glucosidase inhibitors, biguanides, meglitinides, thiazolidinediones 7. Any condition which increases the risk of participation in the trial in the opinion

of the investigator -

Locations and Contacts

University Of California, San Diego, San Diego, California 92103-8765, United States
Additional Information

Starting date: March 2006
Last updated: August 21, 2006

Page last updated: August 23, 2015

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