Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus

Phase 2

Terminated

• Conditions: Insulin Resistance; Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Mifepristone 600 mg daily

• Registration Number: NCT03052400
• Lead Sponsor: Charles Drew University of Medicine and Science

Brief Summary

Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome

Detailed Description

Randomized, double blind, placebo-controlled clinical trial examining the efficacy and safety of mifepristone 600 mg daily in male subjects with type 2 diabetes mellitus, not associated with Cushing's syndrome, and sub-optimally controlled on basal insulin, with or without prandial insulin and/or maximally-tolerated doses of metformin.

Study Timeline

• Study Start: 2017-02-03
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-14
• Primary Completion: 2021-03-31
• Study Completion: 2021-05-31
• Results First Submitted: 2022-09-22
• Results First Submitted QC: 2022-09-22
• Results First Posted: 2022-10-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching, blinded placebo 1 tablet po daily x 2 weeks, followed by matching, blinded placebo 2 tablets po daily x 10 weeks
Mifepristone 600 mg daily	Mifepristone 600 mg daily	Mifepristone 300 mg po daily x 2 weeks, followed by mifepristone 600 mg po daily x 10 weeks

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Baseline to 3 months	Glycemic lowering

Secondary Outcome Measures

Name	Time	Method
PSA	Baseline to 3 months	Prostate-specific antigen level
Basal Insulin Dose	Baseline to 3 months	Total daily basal insulin dosage
Weight	Baseline to 3 months	Weight in kg
Body Mass Index	Baseline to 3 months	Body mass index in kg/m\^2
Systolic BP	Baseline to 3 months	Systolic blood pressure
Diastolic BP	Baseline to 3 months	Diastolic blood pressure
LDL-cholesterol	Baseline to 3 months	Low-density lipoprotein cholesterol
Cortisol	Baseline to 3 months	Serum cortisol level (AM)
ACTH	Baseline to 3 months	Serum adrenocorticotrophic hormone level (AM)
Uric Acid	Baseline to 3 months	Serum uric acid level
Hypoglycemic Events	Baseline to 3 months	Symptomatic mild and severe hypoglycemic events
Adverse Events	Baseline to 3 months	Non-hypoglycemia-related adverse events

Trial Locations

Locations (1)

Charles Drew University of Medicine and Science; 🇺🇸 Los Angeles, California, United States