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

NCT00304538 | Completed Phase 1

• 1 other identifier: DIO-103
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 glucagon in the blood and see how the body responds to the glucagon.

Conditions

Type 1 Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

very low dose (VLD) glucagon DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 -

Sponsors & Collaborators

• DiObex: lead

Study Sites (1)

University Of California, San Diego

San Diego, California, 92103-8765, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Steven Edelman, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 20, 2006
• Study Start: March 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 23, 2006

Record last verified: 2006-08

Locations

US (1)