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.
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
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Chula Vista, California, United States
Additional Information
Starting date: February 2009
Last updated: May 6, 2009
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