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Copy of HUMALOG MIX 50... your multiple choice

This presentation deals with the role of the new formula provided by ELI LILLY & co regarding the role provided by this unique ratio and communicates the exact pt profile vs the other lilly forms
by

ahmad alhussein

on 13 April 2011

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Transcript of Copy of HUMALOG MIX 50... your multiple choice

Humalog mix 50
your multiple choice agenda:
introduction
proof of concept trials:
1-twice daily lispro vs. twice daily human
2-mix 50 tid vs. human bid
3-mix 50 tid vs. basal bolus
adjusted clinical profiles The two defects of type 2 diabetes are insulin resistance and insulin deficiency
Many patients eventually need insulin because of advanced insufficiency in insulin secretion (insulinopenia)
Insulinopenia is caused by (a) ß-cell dysfunction and (b) decreased ß-cell mass
The majority of insulin-requiring patients require both basal and prandial insulin supplementation

WHAT IS THE SIGNIFICANCE BEHIND THE 50/50 RATIO NORMAL
DIABETICS
DISCUSSED SAFETY AND EFFICACY OF CSII VS MDI
BOTH ACHIEVED HBA1C < 7 AT THE ILLUSTRATED RATIOS HERMAN ET AL : CLINICAL STUDIES ON 3 AXIS schernthaner VS TID BID 1' MEAN BG
2' HBA1C,7 POINT BG,HYPOGLYCEMIA ONE PROSPECTIVE CROSS-OVER OPEN-LABELLED RANDOMIZED HISTORY:
CONVENTIONAL INSULIN THERAPY 40 PATIENTS LEAD IN: HUMAN INSULIN MIX FOR ONE MONTH 3 MONTHS MIX 50 3 MONTHS HUMAN MIX RESULTS NOTICE THE SIGNIFICANCE OF THE LM50 VS BOTH 30/70 AND BASELINE ,WHILE HUMAN MIX HAS NO SIGNIFICANCE VS BASELINE *N.B: SIGNIFICANT REDUCTION IN THIS FACTOR VS HUMAN MIX ( THIS IS UNCOMMON IN THE COMPARISON BETWEEN PREMIXED FORMS ) BG EXCURSIONS:
LOWER * AFTer 3 meals VS BASELINE AND 30/70
2 HR PP :
LOWER * AFTER LUNCH AND DINNER VS BASELINE AND 30/70 HYPOGLYCEMIA:
RATE : *
INCIDENCE : COMPARABLE ROSENSTOCK Basal/bolus is considered the ideal insulin treatment for diabetes in terms of physiological action and overall glycemic control (Hirsch et al, 2005)
VS + PARALLEL OPEN LABEL RANDOMIZED DEMONSTRATION OF NON INFERIORITY _by testing diff in hba1c at endpoint



1' CHANGE IN HBA1C AT END POINT



2' 8-POINT BG PROFILE, HYPOGLYCEMIA,INSULIN DOSE,BODY WT 7.5>hba1c<12 374 on lantus + oral for 6 months preprandial should reach 110 mg/dl LM50 patients not reaching FPG target could switch pre-dinner injection to lispro mix 25 assigned groups of similar ages,bmi,duration of diabetes,different ages and races limit for non inferiority was -0.3
the diff in hba1c was -0.22
howaever the confidence interval drove it to the
value -0.38 ,therefore: non-inferiority was not proven however both reached hba1c <7 after 6 months with comparable data thru out the whole study after the 6 months:
8-point bg comparable at all points
except fasting and 2-hr post breakfast
0.2 u/kg/day lower with mix 50 and wt gain is comparable comparable incidents and rates of hypoglycemia roche 1' pp

2' fasting,hba1c,dose,hypoglycemia 6 month,open label, cross over,100 pts most of type 2 100 lispro mix 50 and 25 human 50 and 30/70 12 weeks and switch targets required:
fasting <7.8 mmol/l
and 2 hrs < 10 pp:significantly lower hba1c and dose :comparable hypoglycemia:lower in all who is candidate for me?? someone who needs less shots,does not incr the risk of severe,noct,overall hypoglycemia uncontrolled on mixed insulin bid as long as we increase dose: whether analogue or traditional hba1c above target with bid,shernthaner revealed this in his study
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