Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD1656; Drug: simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096940

D1020C00029

Details and patient eligibility

About

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any metformin or metformin with one other oral anti-diabetic drug (OAD)
• Body mass index between greater than or equal to 19 and less than or equal to 42 kg/m2
• HbA1c greater than 6.5% at enrollment

Exclusion criteria

• Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
• Significant cardiovascular event within the last 6 months prior to enrollment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV

Trial design

44 participants in 3 patient groups

1

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

2

Experimental group

Description:

Simvastatin

Treatment:

Drug: simvastatin

3

Experimental group

Description:

AZD1656 + simvastatin

Treatment:

Drug: simvastatin

Drug: AZD1656