Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD1656; Drug: Placebo; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103622

D1020C00031

Details and patient eligibility

About

The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
• Body mass index between ≥19 and ≤42 kg/m2.
• Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.

Exclusion criteria

• History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
• Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
• Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

twice daily Day 1 to Day 7; digoxin on day 4

Treatment:

Drug: AZD1656

Drug: Digoxin

2

Placebo Comparator group

Description:

twice daily Day 1 to Day 7; digoxin on day 4.

Treatment:

Drug: Placebo

Drug: Digoxin