Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
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.
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.
Inclusion Criteria:

 -  Participated in DIO-502

 Exclusion Criteria:

 -  Did not participate in DIO-502