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

Sponsored by:	DiObex
Information provided by:	DiObex
ClinicalTrials.gov Identifier:	NCT00304538

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: very low dose (VLD) glucagon	Phase I

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Glucagon

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety Study
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

Further study details as provided by DiObex:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	10
Study Start Date:	March 2006
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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 -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304538

Locations

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

Sponsors and Collaborators

DiObex

Investigators

Principal Investigator:

Steven Edelman, MD

University of California, San Diego

More Information

Study ID Numbers:	DIO-103
Study First Received:	March 16, 2006
Last Updated:	August 21, 2006
ClinicalTrials.gov Identifier:	NCT00304538
Health Authority:	United States: Food and Drug Administration

Keywords provided by DiObex:

diabetes

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glucagon
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009