Effect of different fixed pramlintide:insulin dose ratios on postprandial glucose in T1DM

Study identifier:D5570C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 1 Diabetes

Phase

Phase 1

Healthy volunteers

No

Study drug

Pramlintide acetate

Sex

All

Actual Enrollment

32

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Nov 2012
Primary Completion Date: 01 Sept 2013
Study Completion Date: 01 Sept 2013

Study design

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

AstraZeneca, Juvenile Diabetes Research Foundation

Inclusion and exclusion criteria