A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00302224. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2a, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Study of Safety, Tolerability, Pharmacokinetics and Activity of 14 Days of Oral Dosing With the 2S,4R Enantiomer of Ketoconazole (DIO-902) in Subjects With Type 2 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed to test the safety, tolerability of a newly developed form of ketoconazole (DIO-902) for the treatment of elevated blood sugars in type 2 diabetes. This study also will also examine the effect of the drug on total and LDL cholesterol and blood pressure. Elevated cortisol may contribute to the development of Type II diabetes. The investigational drug DIO-902 may reduce the level of cortisol in blood and therefore provide better control of blood sugar levels in patients with Type II diabetes.
Study identification
- NCT ID
- NCT00302224
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2005
- Primary completion
- Not listed
- Completion
- Jul 31, 2006
- Last update posted
- Feb 21, 2008
2005 – 2006
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Asha Thomas, MD - Medstar | Washington D.C. | District of Columbia | 20003 | — |
| Marc Rendell, MD - Creighton University | Omaha | Nebraska | 68131 | — |
| Dr. Andrew Ahmann, MD - Radiant Research | Portland | Oregon | 97239 | — |
| Carlos Arauz-Pacheco, MD - Radiant Research | Dallas | Texas | 75247 | — |
| Sherwin Schwartz, MD - Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00302224, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 21, 2008 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00302224 live on ClinicalTrials.gov.