Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type II Diabetes

In brief

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin

Key facts

Study ID

NCT00856908

Run by

AstraZeneca

People needed

20

Starts

2009-02-01

Expected to finish

2009-08-01

Last updated by the study team

2012-12-06

Who can join

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

You may qualify if…

• type II diabetes patients, female with non child-bearing potential
• Subjects with T2DM diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. Subjects must have been treated with insulin the last 3 months prior to enrolment (screening)
• HbA1c <11% at enrolment (screening) (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard).
• FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

You may not qualify if…

• History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
• Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation.
• Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.

Where it is running

• Research Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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