To Evaluate the Response to Glucagon During Hypoglycemia

AstraZeneca8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

AZD1656DRUG

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

GlucagonDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

Research Site

Chula Vista, California, United States

Outcomes

Primary Outcomes

P-Glucose levels

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

Secondary Outcomes

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

Time frame: 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

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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.