Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
- Registration Number
- NCT00622089
- Lead Sponsor
- DiObex
- Brief 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.
- Detailed Description
To maintain the blind in Protocol DIO-502, subjects will be re-randomized at Study Visit 1 to one of three doses of DIO-902: 150, 300 or 450 mg QHS. All subjects receiving DIO-902 placebo and 50% of subjects receiving DIO-902 will be re-randomized to one of three DIO-902 doses. The remaining 50% of subjects receiving DIO-902 will be assigned to their original DIO-902 dose. The re- randomization will be performed by a group independent of study conduct to ensure the treatment status of the subject while in Protocol DIO-502 remains blinded. In addition, subjects will continue on the same dose of metformin that they had been taking during the conduct of Protocol DIO-502. Subjects will continue on atorvastatin 10 mg for the first 4 weeks of this protocol. Thereafter, at Study Visits 3 and 4, the dose of atorvastatin may be increased up to a maximum of 40 mg daily in order to achieve LDL-cholesterol/non-HDL cholesterol goals specified within the protocol. In addition, after Study Visit 4 (Week 12) subjects with HbA1c levels of \> 7.5% (0.075 Hb Fract.) will undergo a one time titration of their oral hypoglycemic regimen as per the algorithm provided in the protocol.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
- Participated in DIO-502
- Did not participate in DIO-502
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 DIO-902 150mg DIO-902 + 10mg Atorvastatin 2. DIO-902 300mg DIO-902 + 10mg Atorvastatin 3 DIO-902 450mg DIO-902 + 10mg Atorvastatin
- Primary Outcome Measures
Name Time Method The following parameters will be evaluated at Week 12 and Week 24: • Proportion of subjects who reach the lipid goal as defined in the protocol from baseline • Proportion of subjects who meet the HbA1c goal as defined in the protocol from baseline 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Diabetes Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States
ECRU
🇦🇺Box Hill, Melbourne, Victoria, Australia
Endocrinology Department
🇦🇺St Leonards, Australia
Genova Research
🇺🇸Tucson, Arizona, United States
AHS Oklahoma Physician Group
🇺🇸Tulsa, Oklahoma, United States
Covance Clinical Research Unit - Dr. Andrew Ahmann
🇺🇸Portland, Oregon, United States
Advanced Medical Research
🇺🇸Lakewood, California, United States
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Dr. Terence Hart
🇺🇸Muscle Shoals, Alabama, United States
Arkansas Primary Care Clinic
🇺🇸Little Rock, Arkansas, United States
School of Medicine and Pharmacology
🇦🇺Fremantle, Western Australia, Australia
Keough Institute
🇦🇺Nedands, Western Australia, Australia
Covance CRU
🇺🇸Austin, Texas, United States
Mills-Peninsula Helath Services
🇺🇸San Mateo, California, United States
Research Solutions
🇺🇸Jonesboro, Arkansas, United States
Diabetes Research Goup University of Hawaii at Manoa
🇺🇸Honolulu, Hawaii, United States
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Lyell McEwin Hospital
🇦🇺North Western Adelaide, South Australia, Australia
Endocrinology Research Unit
🇦🇺Herston Road, Australia
Middlemore Hospital
🇳🇿Otahuhu, Auckland, New Zealand
Royal Melbourn Hospital
🇦🇺Victoria, Australia
Waikaito Hospital
🇳🇿Hamilton, New Zealand
Lipid and Diabetes Research
🇳🇿Christchurch, New Zealand
Diabetes Centre
🇳🇿Wellington, New Zealand