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Sponsored by: |
DiObex |
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Information provided by: | DiObex |
ClinicalTrials.gov Identifier: | NCT00304538 |
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 |
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Type 1 Diabetes |
Drug: very low dose (VLD) glucagon |
Phase I |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | July 2006 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
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United States, California | |
University Of California, San Diego | |
San Diego, California, United States, 92103-8765 |
Principal Investigator: | Steven Edelman, MD | University of California, San Diego |
Study ID Numbers: | DIO-103 |
Study First Received: | March 16, 2006 |
Last Updated: | August 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00304538 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetes |
Metabolic Diseases Autoimmune Diseases Glucagon Hormone Antagonists Diabetes Mellitus Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases |
Diabetes Mellitus Type 1 Hormones Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Autoimmune Diseases Immune System Diseases Glucagon Physiological Effects of Drugs Diabetes Mellitus Hormones, Hormone Substitutes, and Hormone Antagonists |
Gastrointestinal Agents Endocrine System Diseases Hormones Pharmacologic Actions Diabetes Mellitus, Type 1 Therapeutic Uses Glucose Metabolism Disorders |