Study identifier:D5570C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus
Type 1 Diabetes
Phase 1
No
Pramlintide acetate
All
32
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Oct 2014 by AstraZeneca
AstraZeneca
AstraZeneca, Juvenile Diabetes Research Foundation
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Pramlintide 6 mcg per unit of insulin dose The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin. | - |
Experimental: Pramlintide 9 mcg per unit of insulin dose The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin. | - |
Experimental: Pramlintide 12 mcg per unit of insulin dose The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin. | - |
Placebo Comparator: Placebo | Other: Placebo Placebo Comparator |