Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus
Brief summary
The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
Interventions
DRUGAZD1656
3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.
DRUGPlacebo
Placebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated, written informed consent prior to any study specific procedures. * Male, T2DM patients aged 20-60 years * Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment * Patients should not have been treated with glitazones within 6 months prior to enrollment * Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).
Exclusion criteria
* History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease. * Prolonged QTcF\>450 msec or shortened QTcF\<350 msec or family history of long QT syndrome. * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. * Systolic BP\>159 mmHg or diastolic BP\>99 mmHg at screening and on Day-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state. | From screening until Follow up |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656 | From pre-dose Day 1 to 48 hours after dose |
| Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656 | Glucose levels from Day -1 to day 3 |
Countries
United States
Outcome results
None listed