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A Phase 2b Study of DIO-902 or DIO-902 Placebo in Addition to Metformin and Atorvastatin or Atorvastatin Placebo for Type 2 Diabetes

NCT00494663 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-11-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

DIO-902

150mg tablet once per day for 16 weeks

DRUG

DIO-902

300mg tablet once per day for 16 weeks

DRUG

DIO-902

450mg DIO-902 tablet once daily for 16 weeks

DRUG

DIO-902 placebo

DIO-902 placebo tablet once daily for 16 weeks

DRUG

DIO-902

150mg tablet of DIO-902 once daily for 16 weeks

DRUG

DIO-902

300mg DIO-902 tablet daily for 16 weeks

DRUG

DIO-902

450mg DIO-902 tablet for 16 weeks

DRUG

DIO-902 placebo

DIO-902 placebo tablet once daily for 16 weeks

Sponsors & Collaborators

  • DiObex

    lead INDUSTRY

Principal Investigators

  • Sherwyn Schwartz, MD · Diabetes & Glandular Disease Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-03-31
Completion
2008-12-31

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00494663 on ClinicalTrials.gov