| Trial ID: | L4504 |
| Source ID: | NCT01265017
|
| Associated Drug: |
Estradiol, Medroxyprogesterone, Hydrocortisone, Gh
|
| Title: |
Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Estradiol, medroxyprogesterone, hydrocortisone, GH|DRUG: Matching placebo
|
| Outcome Measures: |
Primary: stimulated C-peptide response, The primary efficacy endpoint is the Week 6 change from Baseline in stimulated C peptide response. It will be modeled as a function of treatment group and baseline stimulated C peptide using an analysis of covariance model. The assessment at the Screening Visit will serve as the baseline assessment in computing the C peptide change from baseline endpoint, 6 weeks | Secondary: Clinical, immunologic and hormonal responses, The following secondary efficacy endpoint will be summarized descriptively and graphically by treatment group to which subjects were randomized: Week 6 changes from Baseline in the following: HbA1c, Total daily insulin requirement, IAA, GADA, IA-2A, ICA (pending the availability of sample processing, ZnT8A (pending the availability of sample processing), IGF-1, Prolactin, Growth hormone, Cortisol, 6 weeks|Insulin requirement, Proportion of subjects with a 25% or greater decrease from Baseline in total daily insulin requirement at Week 6, 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sansum Diabetes Research Institute
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2012-07
|
| Completion Date: |
2020-06
|
| Results First Posted: |
|
| Last Update Posted: |
2018-04-18
|
| Locations: |
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01265017
|
