Clinical trial NCT01103622: Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
Official title: An Open-label, Randomised, Placebo Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics of Digoxin During Co-administration With AZD1656
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Type 2
Digoxin
drug-drug interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
timeFrame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
Secondary outcomes:
measure: evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.
timeFrame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
measure: describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
timeFrame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
measure: describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
timeFrame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca
name: Stanko Skrtic
role: STUDY_DIRECTOR
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Christoph Kapitza
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mirjana Kujacic
role: STUDY_CHAIR
References: