Overview

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

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
DiObex
Treatments:
Glucagon
Glucagon-Like Peptide 1
Criteria
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 -