Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea

Completed · Phase 1 · Has a placebo group

Conditions studied: Type II Diabetes Mellitus

In brief

The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.

Key facts

Study ID

NCT00995787

Run by

AstraZeneca

People needed

75

Starts

2009-10-01

Expected to finish

2010-02-01

Last updated by the study team

2010-02-26

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — San Diego, California, United States

Full record on ClinicalTrials.gov

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