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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790153
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : April 10, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly up to 6 hours during study days ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]
  2. Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) [ Time Frame: Taken repeatedly during treatment periods ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790153


Locations
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United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Klas Malmberg, MD, PhD, Prof AstraZeneca R&D Mölndal
Principal Investigator: Linda Morrow, MD Profil Institute for Clinical Research, Inc.
More Information
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Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00790153    
Other Study ID Numbers: D1020C00012
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009
Keywords provided by AstraZeneca:
Type 2 diabetes, hormonal response
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs