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

Completed · Phase 1

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID: NCT00304538
Run by: DiObex
People needed: 10
Starts: 2006-03-01
Expected to finish: 2006-07-01
Last updated by the study team: 2006-08-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 -

Where it is running

University Of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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