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OpenTrials
Completed

NCT Number: NCT00817271

To Evaluate the Response to Glucagon During Hypoglycemia

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1656

Drug

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

glucagon

Drug

1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8

Primary outcomes

  1. P-Glucose levels

    Time frame: Repeated sampling during the 24 hour period on day 5 and 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
May 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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