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To Evaluate the Response to Glucagon During Hypoglycemia

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: AZD1656 (Drug); Glucagon (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Klas Malmberg, MD, PhD, Prof., Study Director, Affiliation: AstraZeneca R&D Mölndal
Marcus Hompesch, MD, Principal Investigator, Affiliation: Profil Institut for Clinical Research Inc.


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: P-Glucose levels

Secondary outcome:

Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)

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

Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Research Site, Chula Vista, California, United States
Additional Information

Starting date: February 2009
Last updated: May 6, 2009

Page last updated: August 23, 2015

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