Back to resultsInvestigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD1656
Pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Pioglitazone
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed Type 2 Diabetes Mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug
- Body mass index between ≥19 and ≤42 kg/m2.
Exclusion Criteria:
- Impaired renal function
- Clinically significant illness or clinically relevant trauma.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15
Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15
Outcomes
Primary Outcome Measures
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of AUC (0-24) and Cmax.
Secondary Outcome Measures
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of tmax, t1/2 and CL/F.
To evaluate the pharmacokinetics of the AZD1656 and its metabolite, when AZD1656 is administered with and without pioglitazone, by assessment of AUC(0 24), Cmax and tmax.
To evaluate the pharmacokinetics of the Pioglitazone metabolite hydroxyl pioglitazone, when pioglitazone is administered with and without AZD1656, by assessment of AUC(0-24), Cmax and tmax.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01082120
Brief Title
Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus
Official Title
Open, Randomized, Phase I Study in Subjects With Type 2 Diabetes Mellitus Treated With Metformin to Evaluate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether administration of AZD1656 will affect the pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Pioglitazone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15
Arm Title
2
Arm Type
Experimental
Arm Description
Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15
Intervention Type
Drug
Intervention Name(s)
AZD1656
Intervention Description
Tablets orally, twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Tablet oral single dose for 10 days
Primary Outcome Measure Information:
Title
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of AUC (0-24) and Cmax.
Time Frame
Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Secondary Outcome Measure Information:
Title
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of tmax, t1/2 and CL/F.
Time Frame
Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Title
To evaluate the pharmacokinetics of the AZD1656 and its metabolite, when AZD1656 is administered with and without pioglitazone, by assessment of AUC(0 24), Cmax and tmax.
Time Frame
Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Title
To evaluate the pharmacokinetics of the Pioglitazone metabolite hydroxyl pioglitazone, when pioglitazone is administered with and without AZD1656, by assessment of AUC(0-24), Cmax and tmax.
Time Frame
Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed Type 2 Diabetes Mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug
Body mass index between ≥19 and ≤42 kg/m2.
Exclusion Criteria:
Impaired renal function
Clinically significant illness or clinically relevant trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanko Skrtic
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elaine Watkins, DO
Organizational Affiliation
Profil Institute for Clinical Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mirjana Kujacic
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus
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