| Trial ID: | L5223 |
| Source ID: | NCT00304538
|
| Associated Drug: |
Very Low Dose (Vld) Glucagon
|
| Title: |
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Very Low Dose-Glucagon in Subjects With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: very low dose (VLD) glucagon
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: DiObex
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-03
|
| Completion Date: |
2006-07
|
| Results First Posted: |
|
| Last Update Posted: |
2006-08-23
|
| Locations: |
University Of California, San Diego, San Diego, California, 92103-8765, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00304538
|
