NCT01265017

Role of Pregnancy Related Hormones in Lowering the Insulin Requirement in Pregnant Women With Type 1 Diabetes

Single-center, Double-masked, Placebo-controlled Parallel-group Study of Pregnancy-related Hormones Estradiol and Medroxyprogesterone, in Conjunction With Hydrocortisone and Growth Hormone to Stimulate C-peptide Secretion in Women With T1DM

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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: * Determine whether the study treatment leads to a change in T1DM autoantibodies between Baseline and Week 6 * Determine the percentage of subjects experiencing a clinically significant decline in total daily insulin requirement at Week 6, defined as a 25% decrease from Baseline * Descriptively evaluate the association between serum levels of growth hormone, cortisol, and prolactin and changes in C-peptide levels * Evaluate the safety of administration of the study treatments compared with placebo, as measured by blood pressure, pulse, weight change, blood glucose, and adverse events (AEs)

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Estradiol, medroxyprogesterone, hydrocortisone, GH	* 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	Matching placebo	matching placebo

Timeline

• Start date: 2012-07-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2010-12-22
• Last updated: 2018-04-18

Locations

1 site across 1 country: United States