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

COMPLETEDPHASE1

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

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

NCT00304538•DiObex

View on ClinicalTrials.gov

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.

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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
+5 more 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 -

Locations (1)

University Of California, San Diego

San Diego, California, United States

Key Dates

Start Date

March 1, 2006

Completion Date

July 1, 2006

Last Updated

August 23, 2006

Enrollment

Estimated participants

Conditions

Type 1 Diabetes

Interventions

very low dose (VLD) glucagon

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Dysautonomia in Children With Type 1 Diabetes

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Lipoprotein Kinetics in T1D

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery