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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00790153

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Insulin Drug: AZD1656	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 AZD1656	Drug: AZD1656 Single dose oral suspension given at one occasion.
Active Comparator: 2 Insulin	Drug: Insulin Insulin infusion given during 3 hours at one occasion.

Arm

Intervention/Treatment

Active Comparator: 1

AZD1656

Drug: AZD1656

Single dose oral suspension given at one occasion.

Active Comparator: 2

Insulin

Drug: Insulin

Insulin infusion given during 3 hours at one occasion.

Outcome Measures

Primary Outcome Measures

Pharmacodynamic variables [Blood samples taken repeatedly up to 6 hours during study days]

Secondary Outcome Measures

Pharmacokinetic variables [Blood samples taken repeatedly during 24 hours on study day sessions]
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) [Taken repeatedly during treatment periods]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Chula Vista	California	United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Klas Malmberg, MD, PhD, Prof, AstraZeneca R&D Mölndal
Principal Investigator: Linda Morrow, MD, Profil Institute for Clinical Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00790153

Other Study ID Numbers:

D1020C00012

First Posted:

Nov 13, 2008

Last Update Posted:

Apr 10, 2009

Last Verified:

Apr 1, 2009

Keywords provided by , ,

Type 2 diabetes, hormonal response

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Insulin

Study Results

No Results Posted as of Apr 10, 2009