Overview

To Evaluate the Response to Glucagon During Hypoglycemia

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Glucagon
Glucagon-Like Peptide 1
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