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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00790153

Enrollment

Registered

2008-11-13

Start date

2008-11-30

Completion date

2009-02-28

Last updated

2009-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes, hormonal response

Brief summary

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

Interventions

DRUGInsulin

Insulin infusion given during 3 hours at one occasion.

DRUGAZD1656

Single dose oral suspension given at one occasion.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic variables	Blood samples taken repeatedly up to 6 hours during study days

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026