Type 2 Diabetes
Conditions
Keywords
Type II Diabetes, Counter-regulatory response, Hypoglycemia
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
Interventions
DRUGAZD1656
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
DRUGGlucagon
1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| P-Glucose levels | Repeated sampling during the 24 hour period on day 5 and 8 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) | Frequent measurements during the study period |
| 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 | Repeated sampling during the 24 hour period on day 5 and 8 |
| Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide) | Repeated sampling during the 24 hour period on day 5 and 8 |
Countries
United States
Outcome results
None listed