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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone; Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082120

D1020C00028

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

AZD1656 day 1-5, AZD1656 + Pioglitazone day 6-10, Pioglitazone day 11-15

Treatment:

Drug: AZD1656

Drug: Pioglitazone

2

Experimental group

Description:

Pioglitazone day 1-5, AZD1656 + Pioglitazone day 6-10, AZD1656 day 11-15

Treatment:

Drug: AZD1656

Drug: Pioglitazone