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To Evaluate the Response to Glucagon During Hypoglycemia

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ClinicalTrials.gov Identifier: NCT00817271
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : May 7, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: AZD1656 Drug: Glucagon Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2009
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Glucagon
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. P-Glucose levels [ Time Frame: Repeated sampling during the 24 hour period on day 5 and 8 ]

Secondary Outcome Measures :
  1. Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) [ Time Frame: Frequent measurements during the study period ]
  2. 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 ]
  3. Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide) [ Time Frame: Repeated sampling during the 24 hour period on day 5 and 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

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
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins