Type II Diabetes Mellitus
Conditions
Keywords
Type II diabetes mellitus, metformin, sulfonylurea
Brief summary
The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.
Interventions
DRUGAZD1656
Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
DRUGPlacebo
Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or females of non-childbearing potential * Patients treated with a combination of Metformin and SU (glyburide, glimepiride, glibenclamide, glipizide or gliclazide) in stable doses for at least 2 months prior to enrolment visit * Patients should have FPG in the range of 6,0 to 14 mmol/L (108 to 250 mg/dL) at enrolment and on the morning of randomisation
Exclusion criteria
* History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease * Impaired renal function in terms of GFR\<60 ml/min * Use of insulin, glitazones, gemfibrozil, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, e.g., ketoconazole within 14 days before randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG | AE will be collected from the time for randomisation until follow-up visit. Safety variables and vital signs will be measured at the pre-entry, during study days -2 to 10 and at the follow-up visit. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables: (Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) | Blood samples for analysis of plasma concentrations of AZD1656 will be collected on study days 6 and 9. The samples for analysis of glipizide will be collected on study days -1 and 6. |
| Pharmacodynamic variables: 24 h plasma glucose, Insulin | Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9. |
Countries
United States
Outcome results
None listed