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

Completed · Phase 1 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01103622

Run by

AstraZeneca

People needed

20

Starts

2010-06-01

Expected to finish

2010-12-01

Last updated by the study team

2011-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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