Clinical trial NCT00622089: Open Label Safety & Pharmacodynamic Study 24Wk w/DIO-902 Combo w/Metformin & Atorvastatin in T2DM Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Keywords: diabetes
type 2 diabetes
cholesterol
Lead sponsor: DiObex
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Participated in DIO-502

Exclusion Criteria:

* Did not participate in DIO-502

Primary outcomes:
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Dr. Terence Hart
state: Alabama
city: Tucson
country: United States
facility: Genova Research
state: Arizona
city: Jonesboro
country: United States
facility: Research Solutions
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic
state: Arkansas
city: Lakewood
country: United States
facility: Advanced Medical Research
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Helath Services
state: California
city: Honolulu
country: United States
facility: Diabetes Research Goup University of Hawaii at Manoa
state: Hawaii
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Tulsa
country: United States
facility: AHS Oklahoma Physician Group
state: Oklahoma
city: Portland
country: United States
facility: Covance Clinical Research Unit - Dr. Andrew Ahmann
state: Oregon
city: Austin
country: United States
facility: Covance CRU
state: Texas
city: San Antonio
country: United States
facility: Diabetes Glandular Disease Research Associates
state: Texas
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: North Western Adelaide
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Box Hill, Melbourne
country: Australia
facility: ECRU
state: Victoria
city: Fremantle
country: Australia
facility: School of Medicine and Pharmacology
state: Western Australia
city: Nedands
country: Australia
facility: Keough Institute
state: Western Australia
city: Herston Road
country: Australia
facility: Endocrinology Research Unit
city: St Leonards
country: Australia
facility: Endocrinology Department
city: Victoria
country: Australia
facility: Royal Melbourn Hospital
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
state: Auckland
city: Christchurch
country: New Zealand
facility: Lipid and Diabetes Research
city: Hamilton
country: New Zealand
facility: Waikaito Hospital
city: Wellington
country: New Zealand
facility: Diabetes Centre
Study officials:
References: