Status:
COMPLETED
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Very Low Dose-Glucagon in Subjects With Type 1 Diabetes Mellitus
Lead Sponsor:
DiObex
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 gluca...
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 glyce...
Eligibility Criteria
Inclusion
- Males or females, 18 to 55 years of age, requiring daily insulin for the management of type 1 diabetes mellitus for \>10 years
- 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)
- Glycosylated hemoglobin (HbA1c) ≤8.0%
- Total daily insulin requirement of ≤1 unit/kg of body weight
- 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)
- Body mass index (BMI) ≤25.5 kg/m2 and body weight over past 6 months within ± 5%
- Hemoglobin, hematocrit, and platelets within normal limits; no clinically significant abnormality of white blood cells (WBC) or differential
- 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
- Normal thyroid stimulating hormone
- No history of HIV infection and negative results for hepatitis B and C
- Negative serum pregnancy test, non-lactating, and using adequate contraception, if female and of child bearing potential (intact uterus and pre-menopausal)
- Medications for the treatment of high blood pressure and/or dyslipidemia are allowed if regimen stable for 2 months prior to screening
- Medically stable as determined by history and physical examination, including vital signs
- Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality
- Willing and able to give written informed consent
Exclusion
- Participation in a clinical trial with or use of an investigational agent within 30 days of Study Visit 1.
- History of atherosclerosis including coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident, or transient ischemic attacks
- History or symptoms of pheochromocytoma
- History of any malignancy within 3 years except for basal cell skin cancer
- Active infection, drug or alcohol abuse, eating disorder, or psychiatric disorder
- Concomitant medications: systemic or potent topical steroids or medications that may affect blood glucose, e.g., sulfonylureas, alpha-glucosidase inhibitors, biguanides, meglitinides, thiazolidinediones
- Any condition which increases the risk of participation in the trial in the opinion of the investigator -
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00304538
Start Date
March 1 2006
End Date
July 1 2006
Last Update
August 23 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Of California, San Diego
San Diego, California, United States, 92103-8765