search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DIO-902
DIO-902
DIO-902
Sponsored by
DiObex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, type 2 diabetes, cholesterol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participated in DIO-502

Exclusion Criteria:

  • Did not participate in DIO-502

Sites / Locations

  • Dr. Terence Hart
  • Genova Research
  • Research Solutions
  • Arkansas Primary Care Clinic
  • Advanced Medical Research
  • Mills-Peninsula Helath Services
  • Diabetes Research Goup University of Hawaii at Manoa
  • Creighton Diabetes Center
  • AHS Oklahoma Physician Group
  • Covance Clinical Research Unit - Dr. Andrew Ahmann
  • Covance CRU
  • Diabetes Glandular Disease Research Associates
  • Flinders Medical Centre
  • Lyell McEwin Hospital
  • ECRU
  • School of Medicine and Pharmacology
  • Keough Institute
  • Endocrinology Research Unit
  • Endocrinology Department
  • Royal Melbourn Hospital
  • Middlemore Hospital
  • Lipid and Diabetes Research
  • Waikaito Hospital
  • Diabetes Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2.

3

Arm Description

150mg DIO-902 + 10mg Atorvastatin

300mg DIO-902 + 10mg Atorvastatin

450mg DIO-902 + 10mg Atorvastatin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 3, 2008
Last Updated
May 22, 2008
Sponsor
DiObex
search

1. Study Identification

Unique Protocol Identification Number
NCT00622089
Brief Title
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

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Program terminated
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
DiObex

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, type 2 diabetes, cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
150mg DIO-902 + 10mg Atorvastatin
Arm Title
2.
Arm Type
Experimental
Arm Description
300mg DIO-902 + 10mg Atorvastatin
Arm Title
3
Arm Type
Experimental
Arm Description
450mg DIO-902 + 10mg Atorvastatin
Intervention Type
Drug
Intervention Name(s)
DIO-902
Intervention Description
150mg DIO-902 + 10mg atorvastatin
Intervention Type
Drug
Intervention Name(s)
DIO-902
Intervention Description
300mg dose once per day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
DIO-902
Intervention Description
450mg dose once per day for 24 weeks
Primary Outcome Measure Information:
Title
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participated in DIO-502 Exclusion Criteria: Did not participate in DIO-502
Facility Information:
Facility Name
Dr. Terence Hart
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Genova Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Research Solutions
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Primary Care Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Advanced Medical Research
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Mills-Peninsula Helath Services
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Diabetes Research Goup University of Hawaii at Manoa
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
AHS Oklahoma Physician Group
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Covance Clinical Research Unit - Dr. Andrew Ahmann
City
Portland
State/Province
Oregon
ZIP/Postal Code
927239
Country
United States
Facility Name
Covance CRU
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Diabetes Glandular Disease Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Lyell McEwin Hospital
City
North Western Adelaide
State/Province
South Australia
Country
Australia
Facility Name
ECRU
City
Box Hill, Melbourne
State/Province
Victoria
Country
Australia
Facility Name
School of Medicine and Pharmacology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Keough Institute
City
Nedands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Endocrinology Research Unit
City
Herston Road
ZIP/Postal Code
QLD 4029
Country
Australia
Facility Name
Endocrinology Department
City
St Leonards
ZIP/Postal Code
NSW 2065
Country
Australia
Facility Name
Royal Melbourn Hospital
City
Victoria
Country
Australia
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
Country
New Zealand
Facility Name
Lipid and Diabetes Research
City
Christchurch
Country
New Zealand
Facility Name
Waikaito Hospital
City
Hamilton
Country
New Zealand
Facility Name
Diabetes Centre
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs