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To Evaluate the Response to Glucagon During Hypoglycemia

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00817271
First received: January 5, 2009
Last updated: May 6, 2009
Last verified: May 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the response to Glucagon versus the spontaneous hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and Metformin


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open, Two-Way Cross-Over, Phase I Study to Evaluate the Response to Glucagon Versus the Spontaneous Counter-Regulatory Response in T2DM Patients Treated With AZD1656 and Metformin During Hypoglycemia

Resource links provided by NLM:

Drug Information available for: Glucagon
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • P-Glucose levels [ Time Frame: Repeated sampling during the 24 hour period on day 5 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) [ Time Frame: Frequent measurements during the study period ] [ Designated as safety issue: No ]
  • Pharmacokinetic variables (Area under the plasma conc-time curve from time 0 to 24 hours post dose (AUC0-24), maximum plasma conc(Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance [ Time Frame: Repeated sampling during the 24 hour period on day 5 and 8 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide) [ Time Frame: Repeated sampling during the 24 hour period on day 5 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: February 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1656
Dose titration of oral suspension during 2 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose for another 6 days. On day 5 and 8 the dose will be given as a single dose
Drug: Glucagon
1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8
Experimental: 2 Drug: AZD1656
Dose titration of oral suspension during 2 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose for another 6 days. On day 5 and 8 the dose will be given as a single dose

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type II diabetes patients, female with non child-bearing potential
  • T2DM diagnosis confirmed by C-peptide >0.3nmol/L and no glutamic acid decarboxylate (GAD) antibodies at enrolment (screening)
  • Treatment with metformin alone with a total daily dose not less than 1 000 mg. Stable glycaemic control indicated by unchanged treatment within 3 months prior to enrolment

Exclusion Criteria:

  • History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
  • Signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study
  • Participating in another clinical study during the last 30 days prior to enrolment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817271

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: Marcus Hompesch, MD Profil Institut 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: NCT00817271     History of Changes
Other Study ID Numbers: D1020C00018
Study First Received: January 5, 2009
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type II Diabetes
Counter-regulatory response
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on June 17, 2013