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Atropine

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00689208Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve ActivityEARLY_PHASE1 COMPLETED 12 — — May 1, 2007Nov 1, 2008Mar 13, 20091 Sweden
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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 — 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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