Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01082120
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 2.9
• Patients Per Site Per Month: 9.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: AZD1656; Drug: Pioglitazone	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15	Drug: AZD1656; Tablets orally, twice daily for 10 days; Drug: Pioglitazone; Tablet oral single dose for 10 days
Experimental: 2 Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15	Drug: AZD1656; Tablets orally, twice daily for 10 days; Drug: Pioglitazone; Tablet oral single dose for 10 days

Outcome Measures

Primary Outcome Measures

1. To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of AUC (0-24) and Cmax. [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 Measures

1. 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. [Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.]

2. 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. [Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.]

3. 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. [Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Chula Vista	California	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Stanko Skrtic, AstraZeneca
• Principal Investigator: Elaine Watkins, DO, Profil Institute for Clinical Research, Inc.
• Study Chair: Mirjana Kujacic, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01082120
• Other Study ID Numbers: D1020C00028
• First Posted: Mar 8, 2010
• Last Update Posted: Jul 12, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Type 2 Diabetes Mellitus; Pioglitazone
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Pioglitazone

Study Results

No Results Posted as of Jul 12, 2010