A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes (MAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747175

D1020C00002

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

Enrollment: 52 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
• Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
• HbA1c ≤10.5 % 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 ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
• Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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52 participants in 2 patient groups

1

Experimental group

Description:

3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)

Treatment:

Drug: AZD1656

Drug: AZD1656

2

Experimental group

Description:

Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Treatment:

Drug: AZD1656

Drug: AZD1656