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**ANA038ComparisonoftheefficacyandsafetyofNovoMix?30andBHI30inatwice-dailymeal-relatedregimen,inamixedpopulationofpatientswithtype1andtype2diabetes.Inthis12-week,randomised,openlabelled,parallel-groupcomparison,294adultmaleandfemalesubjectswhohadbeenusinginsulininatwice-dailyregimenwererandomisedtoreceiveNovoMix?30,injectedwithin10minutesbeforebreakfastanddinner(n=143),orBHI30injectedapproximately30minutespriortobreakfastanddinner(n=151).Ofthese,140patientswereexposedtoNovoMix30,and151wereexposetoBHI30.Threepatientswithdrewfromthestudyafterrandomisation,butbeforeexposure,asitwasfoundthathadnotbeentreatedwithinsulinfortherequiredminimumof2years.Thetreatmentcomparison,whichusedHbA1cafter12weeksastheprimaryefficacyendpoint,wasbasedonanon-inferioritycriterionforthedifferencebetweenthetwobiphasicinsulinsAllpharmacokineticandpharmacodynamicendpointsweresimilarlyanalysedonthebasisofanullhypothesisthattherewasnodifferencebetweentreatments.Safetyandtolerabilityofthetworegimenswasevaluatedbymeasurementofthefrequency,severityandtimingofhypoglycaemicepisodes.**ANA038Summary:Bloodglucoseconcentrationwassignificantlylowerafterbreakfastanddinner,beforelunchandatbedtimeintheNovoMix?30group.Analysisof8-pointbloodglucoseprofilesrevealedsignificantlylowerbloodglucoseconcentrationsafterbreakfastanddinner,beforelunchandatbedtimeintheNovoMix?30group.At12weeks,valueswereapproximately1%lowerintheNovoMix?groupafterbreakfastanddinner(10.4versus11.4mmol/linNovoMix?30andBHI30groupsrespectivelyafterbreakfast,and9.22versus10.2mmol/lafterdinner;p0.05betweengroupsforbreakfastandp0.02fordinner).Beforelunch,bloodglucoseconcentrationsof6.64mmol/lintheNovoMix?30groupcomparedfavour
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