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

This study has been completed.
Sponsor:
Information provided by:
DiObex
ClinicalTrials.gov Identifier:
NCT00304538
First received: March 16, 2006
Last updated: August 21, 2006
Last verified: August 2006
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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:

  1. Males or females, 18 to 55 years of age, requiring daily insulin for the management of type 1 diabetes mellitus for >10 years
  2. 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)
  3. Glycosylated hemoglobin (HbA1c) ≤8.0%
  4. Total daily insulin requirement of ≤1 unit/kg of body weight
  5. 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)
  6. Body mass index (BMI) ≤25.5 kg/m2 and body weight over past 6 months within ± 5%
  7. Hemoglobin, hematocrit, and platelets within normal limits; no clinically significant abnormality of white blood cells (WBC) or differential
  8. 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
  9. Normal thyroid stimulating hormone
  10. No history of HIV infection and negative results for hepatitis B and C
  11. Negative serum pregnancy test, non-lactating, and using adequate contraception, if female and of child bearing potential (intact uterus and pre-menopausal)
  12. Medications for the treatment of high blood pressure and/or dyslipidemia are allowed if regimen stable for 2 months prior to screening
  13. Medically stable as determined by history and physical examination, including vital signs
  14. Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality
  15. Willing and able to give written informed consent

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by DiObex:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014