Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Glucose lowering
Brief summary
To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.
Interventions
DRUGAZD1656
Oral tablet, BID dose
DRUGsimvastatin
Oral tablet, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax. | Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3) |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin and simvastatin acid and vice versa by assessment of tmax, t1/2 and CL/F (only for AZD1656) | Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) |
| To evaluate the steady state pharmacokinetics of the AZD1656 metabolite when AZD1656 is administered with and without simvastatin, by assessment of AUC(0-24), Cmax and tmax. | Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) |
| To evaluate the effect of AZD1656 on the pharmacodynamics of simvastatin by assessment of AUC(0-t) and Cmax of active 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors. | Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) |
| To evaluate the safety and tolerability of AZD1656 alone and in combination with simvastatin by assessments of adverse events, laboratory variables, electrocardiogram, blood pressure, pulse, results of physical examination, and weight. | At pre entry, during the study days, |
Countries
United States
Outcome results
None listed