Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Type 2, Digoxin, drug-drug interaction
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.
Interventions
DRUGAZD1656
Oral tablet bd, step-wise increased dosage
DRUGDigoxin
Oral tablet od on Day 4
DRUGPlacebo
Oral tablet bd, step-wise increased dosage
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Serial PK blood samples will be taken on days 4-8 during the treatment periods |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Safety assessments will be monitored throughout the study, from screening visit until follow up visit. |
| 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). | Serial PK blood samples will be taken on days 4-8 during the treatment periods |
| describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2. | Serial PK blood samples will be taken on days 4-8 during the treatment periods |
Countries
United States
Outcome results
None listed