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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes Mellitus

Treatments: Drug: Placebo; Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995787

D1020C00026

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 2 patient groups, including a placebo group

AZD1656

Experimental group

Treatment:

Drug: AZD1656

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo