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

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790153
• Other study ID #: D1020C00012
• Status: Completed
• Phase: Phase 1
• First received: November 11, 2008
• Last updated: April 9, 2009
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin
Insulin infusion given during 3 hours at one occasion.
• AZD1656
Single dose oral suspension given at one occasion.

Locations

Country	Name	City	State
United States	Research Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic variables		Blood samples taken repeatedly up to 6 hours during study days	No
Secondary	Pharmacokinetic variables		Blood samples taken repeatedly during 24 hours on study day sessions	No
Secondary	Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)		Taken repeatedly during treatment periods	No