To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin; Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790153

D1020C00012

Details and patient eligibility

About

To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.

Enrollment: 12 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers.
• Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
• Have a body mass index (BMI) ≥19 and ≤30

Exclusion criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
• Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
• Daily use of nicotine containing substances.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

1

Active Comparator group

Description:

AZD1656

Treatment:

Drug: AZD1656

2

Active Comparator group

Description:

Insulin

Treatment:

Drug: Insulin