A Phase 2b Study of DIO-902 or DIO-902 Placebo in Addition to Metformin and Atorvastatin or Atorvastatin Placebo for Type 2 Diabetes
Public ClinicalTrials.gov record NCT00494663. 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 2b, Randomized, Double-Blind, Parallel-Group, Study of Safety and Efficacy of 16 Weeks of Treatment With DIO-902 or DIO-902 Placebo in Addition to Metformin and Atorvastatin or Atorvastatin Placebo in Subjects With Type 2 Diabetes Mellitus (Protocol No. DIO-502)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated cortisol may contribute to the development of type 2 diabetes. The purpose of this research study is to test the safety of DIO-902 when taken by mouth with metformin and the cholesterol-lowering drug atorvastatin to determine the type and severity of any side effects from this treatment. Other purposes of the study are to see how the treatment affects your blood glucose levels, cholesterol levels, blood pressure, and waist circumference.
Study identification
- NCT ID
- NCT00494663
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Jul 2007 (Type not available)
- Primary completion
- Mar 2008 (Estimated)
- Completion
- Dec 2008 (Estimated)
- Last update posted
- Nov 13, 2008
2007 – 2008
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dr. Terence Hart | Muscle Shoals | Alabama | 35662 | — |
| Genova Research | Tucson | Arizona | 85741 | — |
| Research Solutions | Jonesboro | Arkansas | 72401 | — |
| Arkansas Primary Care Clinic | Little Rock | Arkansas | 72211 | — |
| Advanced Medical Research | Lakewood | California | 90712 | — |
| Mills-Peninsula Helath Services | San Mateo | California | 94401 | — |
| Diabetes Research Goup University of Hawaii at Manoa | Honolulu | Hawaii | 96813 | — |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | — |
| AHS Oklahoma Physician Group | Tulsa | Oklahoma | 74104 | — |
| Covance Clinical Research Unit - Dr. Andrew Ahmann | Portland | Oregon | 927239 | — |
| Covance CRU | Austin | Texas | 78752 | — |
| Diabetes Glandular and Disease Research Associates | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00494663, 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 Nov 13, 2008 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00494663 live on ClinicalTrials.gov.