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

Condition(s) targeted: Type 2 Diabetes

Intervention: DIO-902 (Drug); DIO-902 (Drug); DIO-902 (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: DiObex

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.

Official title: An Open Label Follow-On Study of Safety and Pharmacodynamic Effects of 24 Weeks of Treatment With DIO-902 in Combination With Metformin and Atorvastatin in Subjects With Type 2 Diabetes Mellitus (Protocol No. DIO-503)

Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participated in DIO-502

Exclusion Criteria:

- Did not participate in DIO-502

Endocrinology Department, St Leonards NSW 2065, Australia; Not yet recruiting
Greg Fulcher, Phone: 02 9926 8388, Email: dfulcher@med.usyd.edu.au
Greg Fulcher, Principal Investigator

Endocrinology Research Unit, Herston Road QLD 4029, Australia; Not yet recruiting
Michael D'Emden, Phone: 07 3636, Ext: 7955, Email: michael.d'emden@health.gld.gov.au
Michael D'Emden, Principal Investigator

Royal Melbourn Hospital, Victoria, Australia; Not yet recruiting
Lee Anne Lynch, Phone: 0393427428, Email: lee-ann.lynch@mh.org.au
Spiros Fourlanos, Principal Investigator

Lipid and Diabetes Research, Christchurch, New Zealand; Not yet recruiting
Zarnia Morrison, Phone: 64 3 3640449, Email: zarnia.morrison@cdhb.govt.nz
Russell Scott, Principal Investigator

Waikaito Hospital, Hamilton, New Zealand; Not yet recruiting
Anne Johnstone, Phone: 64 7 839 8701, Ext: 66, Email: johnstoa@waikatodhb.govt.nz
Peter Dunn, Principal Investigator

Diabetes Centre, Wellington, New Zealand; Not yet recruiting
Linda Kent, Phone: 64 4 9186631, Email: linda.kent@ccdhb.org.nz
Elaine Barrington-Ward, Principal Investigator

Dr. Terence Hart, Muscle Shoals, Alabama 35662, United States; Recruiting
Alice Arnold, Phone: 256-386-1107, Email: aarnold@hiwaay.net
Terence Hart, Principal Investigator

Genova Research, Tucson, Arizona 85741, United States; Recruiting
Mary Drew, Phone: 520-219-6394, Email: mdrew@genovaresearch.com
Leah Schmidt, MD, Principal Investigator

Arkansas Primary Care Clinic, Little Rock, Arkansas 72211, United States; Recruiting
Greta Moore, Phone: 501-661-0531
Derek Lewis, MD, Principal Investigator

Research Solutions, Jonesboro, Arkansas 72401, United States; Recruiting
Todd Carr, Phone: 870-219-9259, Email: tcarr@researchsolutionscorp.com
Kevin Ganong, MD, Principal Investigator

Middlemore Hospital, Otahuhu, Auckland, New Zealand; Not yet recruiting
Terry Gracez, Phone: 64 92760044, Email: gracezt@middlemore.co.nz
Dr. Baker, Principal Investigator

Mills-Peninsula Helath Services, San Mateo, California 94401, United States; Recruiting
Irina Nayberg, Phone: 650-696-4261, Email: nayberi@sutterhealth.org
David Klonoff, Principal Investigator

Advanced Medical Research, Lakewood, California 90712, United States; Recruiting
Mohammed Hassanin, Phone: 562-867-8195, Email: amr@advmedresearch.com
Mansoor Shah, MD, Principal Investigator
Michael Perley, MD, Principal Investigator
Stuart Finkelstein, MD, Principal Investigator

Diabetes Research Goup University of Hawaii at Manoa, Honolulu, Hawaii 96813, United States; Not yet recruiting
Nina Bermudez, Phone: 808-587-8620, Email: ninaeb@hawaii.edu
Richard Arakaki, Principal Investigator

Creighton Diabetes Center, Omaha, Nebraska 68131, United States; Recruiting
Merideth Dynn-Wall, Phone: 402-280-4379, Email: meridethdynn-wall@creighton.edu
Mark Rendell, MD, Principal Investigator

AHS Oklahoma Physician Group, Tulsa, Oklahoma 74104, United States; Recruiting
Lisa Vaughn, Phone: 501-221-5012, Email: lvaughn@researchsolutionscorp.com
Kandace Berner, Phone: 5012215012, Email: kberner@researchsolutionscorp.com
Steven Landgarten, MD, Principal Investigator

Covance Clinical Research Unit - Dr. Andrew Ahmann, Portland, Oregon 927239, United States; Recruiting
Rhonda Muhly, Phone: 503-294-7193, Email: rhonda.muhly@covanc.com
Bethany Klopfenstein, Principal Investigator

Flinders Medical Centre, Adelaide, South Australia, Australia; Not yet recruiting
Pam Taylor, Phone: 08 82769666, Email: pamala.taylor@rgh.sa.gov.au
Steven Stranks, Principal Investigator

Lyell McEwin Hospital, North Western Adelaide, South Australia, Australia; Not yet recruiting
Judy Bradshaw, Phone: 08 878 293 49, Email: judy.bradshaw@nwahs.sa.gov.au
Bill Jeffries, Principal Investigator

Diabetes Glandular Disease Research Associates, San Antonio, Texas 78229, United States; Recruiting
Monica Gonzales, Phone: 210-615-5565, Email: mygonzales@dgdclinic.com
Sherwyn Schwartz, MD, Principal Investigator

Covance CRU, Austin, Texas 78752, United States; Recruiting
Ruth Anne Sullivan, Phone: 512-302-6508, Email: ruthanne.sullivan@covance.com
David Carter, Principal Investigator

ECRU, Box Hill, Melbourne, Victoria, Australia; Not yet recruiting
Joanne Phillips, Phone: 09 98950337, Email: joanne.phillips@med.monash.edu.au
Richard Simpson, Principal Investigator

Keough Institute, Nedands, Western Australia 6009, Australia; Not yet recruiting
Carolyn Earle, Phone: 08 9346 2921, Email: rmri@wt.com.au
Joey Kaye, Principal Investigator

School of Medicine and Pharmacology, Fremantle, Western Australia 6160, Australia; Not yet recruiting
Anna-Marie Dunlop, Phone: 61 8 9431 3229, Email: amarie@meddent.uwa.edu.au
Timothy Davis, Principal Investigator

Starting date: January 2008
Ending date: December 2008
Last updated: February 12, 2008