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Physostigmine

Phase 1

Insulin Resistance | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Mar 13, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Physostigmine · 1 trial · 1 indication

Early Phase 1 1
NCT00689208Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve ActivityInsulin Resistance
COMPLETED12 Analytics
EARLY_PHASE1COMPLETED
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
Insulin Resistance
NCT0068920812
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Study Endpoints

Primary Endpoints

Study the effect of anticholinergic drugs on insulin sensitivity by assessment of glucose infusion rate during hyperinsulinemic euglycemic clamp.
After Insulin bolus, following will be measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).

Secondary Endpoints

Study the effect of cholinergic stimulation on insulin sensitivity by assessment ofglucose infusion rate during hyperinsulinemic euglycemic clamp.
measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
Study the possible difference in effect of cholinergic (physostigmine) andanticholinergic (atropine) drugs on insulin sensitivity in a lean and abdominal obese subgroup of subjects.
measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Interventions

NameTypeDescription
AtropineDRUG10 ug/kg bolus, 4 ug/kg/h infusion
PhysostigmineDRUG0,12ug/kg/min
Placebo SodiumDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed written informed consent * BMI of lean and abdominally obese men and women * weight stable Exclusion Criteria: * Ongoing clinically significant diseases * History of repeated syncope * resting pulse\<50 or systolic blood pressure \<100

Countries:Sweden
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