Glucose Lowering
Conditions
Keywords
Diabetes
Brief summary
To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.
Interventions
DRUGAZD1656
Single dose oral tablet
Sponsors
AstraZeneca
Study design
Allocation
NA
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 OAD or insulin * Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the 4 categories: mild , moderate, severe normal
Exclusion criteria
* Clinically significant progression of current disease or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP * Clinically significant neuropathy according to the Investigator. However subjects with diabetic neuropathy which is not clinically significant according to the Investigator may be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline | The baseline values will be as follows: |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of AZD1656 in T2DM patients with various degrees of renal impairment. To describe the pharmacodynamics of AZD1656 in T2DM patients with various degrees of renal impairment by assessment of 24-hours glucose profile | blood samples will be collected for up to 48 hours postdose and urine samples for up to 12 hours postdose for measurement of plasma and urine concentrations of AZD1656 and its metabolite |
Countries
United States
Outcome results
None listed