A Phase 1 interventional study of Estradiol, medroxyprogesterone, hydrocortisone, GH and Matching placebo in Type 1 Diabetes, sponsored by Sansum Diabetes Research Institute. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Sansum Diabetes Research Institute · Phase 1, Interventional, and Basic science
This is a randomized, double-masked, placebo-controlled, single-center study to evaluate stimulated C-peptide secretion after exogenous administration of mild immunosuppression and growth-promoting factors to women with preexisting T1DM who had a decline in insulin requirement or had detectable C-peptide during a previous pregnancy. Fifteen subjects will be enrolled and randomly assigned in a 2:1 ratio to either active treatment or placebo in a parallel group design.
Participation for individual subjects will consist of an initial Screening Visit, a 2-week baseline period, a Baseline Visit, visits at week 2 and 4 of the treatment period, a visit at the end of the treatment period (week 6), and a follow-up visit 2 weeks after study treatment discontinuation.
Subjects will receive either active treatment or matching placebo of estradiol 1 mg every 8 hours; medroxyprogesterone 2.5 mg every 24 hours; hydrocortisone 2.5 mg every morning, 1.25 mg every afternoon, and 1.25 mg at bedtime each night; and growth hormone 2 mg once a day).
The primary objective of this study is to determine whether women with preexisting T1DM who showed a decline in insulin requirement, defined as a decrease in insulin requirement of 25% or more, or a decrease deemed to be clinically significant by the investigator, with no other medically determined reason, or who had detectable C-peptide during a previous pregnancy will show a change in stimulated C peptide response when not pregnant and treated with exogenous pregnancy-related hormones and growth factors (Estradiol, medroxyprogesterone, hydrocortisone, GH) for 6 weeks.
The secondary objectives of this study are as follows:
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Exclusion Criteria:
interventions include Estradiol, medroxyprogesterone, hydrocortisone, GH as follows * Estradiol 1mg every 8 hours administered orally * Medroxyprogesterone 2.5 mg every 24 hours administered orally * Hydrocortisone 2.5 mg every morning, 1.25 mg every afternoon, and 1.25 mg at bedtime administered orally * Growth hormone 2 mg once a day administered by subcutaneous injection
Drug: Estradiol, medroxyprogesterone, hydrocortisone, GH
Matching placebo
Drug: Matching placebo
* Estradiol 1mg every 8 hours administered orally * Medroxyprogesterone 2.5 mg every 24 hours administered orally * Hydrocortisone 2.5 mg every morning, 1.25 mg every afternoon, and 1.25 mg at bedtime administered orally * Growth hormone 2 mg once a day administered by subcutaneous injection,
Also known as: estradiol,medroxyprogesterone,hydrocortisone,growth hormone
matching placebo
Also known as: inert pills
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
Time frame: 6 weeks
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
Time frame: 6 weeks
Insulin requirement
Proportion of subjects with a 25% or greater decrease from Baseline in total daily insulin requirement at Week 6
Time frame: 6 weeks
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Sansum Diabetes Research Institute