To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: AZD1656; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768105

D1020C00014

Details and patient eligibility

About

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.

Enrollment: 24 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female with non child-bearing potential
• Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
• HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard)

Exclusion criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
• History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
• Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD1656

2

Placebo Comparator group

Treatment:

Drug: Placebo