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

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622089
• Other study ID #: DIO-503
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: January 3, 2008
• Last updated: May 22, 2008
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2008
• Source: DiObex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participated in DIO-502

Exclusion Criteria:

• Did not participate in DIO-502

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• DIO-902
150mg DIO-902 + 10mg atorvastatin
• DIO-902
300mg dose once per day for 24 weeks
• DIO-902
450mg dose once per day for 24 weeks

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	ECRU	Box Hill, Melbourne	Victoria
Australia	School of Medicine and Pharmacology	Fremantle	Western Australia
Australia	Endocrinology Research Unit	Herston Road
Australia	Keough Institute	Nedands	Western Australia
Australia	Lyell McEwin Hospital	North Western Adelaide	South Australia
Australia	Endocrinology Department	St Leonards
Australia	Royal Melbourn Hospital	Victoria
New Zealand	Lipid and Diabetes Research	Christchurch
New Zealand	Waikaito Hospital	Hamilton
New Zealand	Middlemore Hospital	Otahuhu	Auckland
New Zealand	Diabetes Centre	Wellington
United States	Covance CRU	Austin	Texas
United States	Diabetes Research Goup University of Hawaii at Manoa	Honolulu	Hawaii
United States	Research Solutions	Jonesboro	Arkansas
United States	Advanced Medical Research	Lakewood	California
United States	Arkansas Primary Care Clinic	Little Rock	Arkansas
United States	Dr. Terence Hart	Muscle Shoals	Alabama
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Covance Clinical Research Unit - Dr. Andrew Ahmann	Portland	Oregon
United States	Diabetes Glandular Disease Research Associates	San Antonio	Texas
United States	Mills-Peninsula Helath Services	San Mateo	California
United States	Genova Research	Tucson	Arizona
United States	AHS Oklahoma Physician Group	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
DiObex

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No