NCT00790153

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 type-2-diabetes

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 10, 2009

Status Verified

April 1, 2009

First QC Date

November 11, 2008

Last Update Submit

April 9, 2009

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes, hormonal response

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic variables

    Blood samples taken repeatedly up to 6 hours during study days

Secondary Outcomes (2)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

AZD1656

Drug: AZD1656

2

ACTIVE COMPARATOR

Insulin

Drug: Insulin

Interventions

InsulinDRUG

Insulin infusion given during 3 hours at one occasion.

2
AZD1656DRUG

Single dose oral suspension given at one occasion.

1

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

InsulinAZD1656

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Klas Malmberg, MD, PhD, Prof

    AstraZeneca R&D Mölndal

    STUDY DIRECTOR

  • Linda Morrow, MD

    Profil Institute for Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

November 1, 2008

Study Completion

February 1, 2009

Last Updated

April 10, 2009

Record last verified: 2009-04

Locations

US(1)