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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00790153
First received: November 11, 2008
Last updated: April 9, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Insulin
Drug: AZD1656
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly up to 6 hours during study days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
  • Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) [ Time Frame: Taken repeatedly during treatment periods ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2008
Study Completion Date: February 2009
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790153

Locations
United States, California
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.
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00790153     History of Changes
Other Study ID Numbers: D1020C00012
Study First Received: November 11, 2008
Last Updated: April 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type 2 diabetes, hormonal response

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014