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Insulin initiation made safer and simpler (Premix analogue)

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Presentation on theme: "Insulin initiation made safer and simpler (Premix analogue)"— Presentation transcript:

1 Insulin initiation made safer and simpler (Premix analogue)

2 2 Simple convenient meal-time regimen 24-hour better physiological control High safety Once-a-day dosing with OADs gives superior control FlexPen – Patient and prescriber acceptance NovoMix 30 Vs. Glargine: New data Once daily NovoMix 30 with OADs: New study High safety: 4 yr data (Premix analogue)

3 3 Simple convenient meal-time regimen –3 studies 24-hour better physiological control High safety Once-a-day dosing with OADs gives superior control FlexPen – Patient and prescriber acceptance (Premix analogue)

4 4 NovoMix ® 30 can be given pre- or post-meal (1) Warren et al. Diabetes Res Clin Pract Oct;66(1):23- 9 Preprandial dosing (NovoMix ® 30, bid) Postprandial dosing (NovoMix ® 30, bid) Before breakfast Before dinner 2 hrs after breakfast 2 hrs after dinner Blood glucose levels (mg/dl) n = 91 p = NS in all cases 12-wk, crossover, N=92 (elderly) T2DM (Premix analogue) Similar BG, given pre- or post meal Study 1

5 5 NovoMix ® 30 can be given pre- or post-meal (2) Blood glucose (mmol/l) –2 –4 4 Time (min) NovoMix ® 30 ( t= +15 min) NovoMix ® 30 (t = 0 min) Human Mixtard ® 30 (t = 0 min) Human Mixtard® 30 (t = –15 min) Kapitza et al. Diabetic Medicine 2004; 21:500–1 Open-label, crossover trial, N=31, T2DM Study 2

6 6 Human Mixtard® 30 NovoMix ® 30 Blood glucose excursion 4 h after injection (mmol.min.l -1 ) t = 0 t = – 30 Injection time in relation to meal p < % p = Hermansen et al. Metabolism 2002;51(7):896–900 9% t = 0 PPG control better than Human Mixtard ® 30 with- or before meal Randomized, crossover, 3-arm, single dose comparison with Human Mixtard ® 30, T1DM, N=50 (Premix analogue) Study 3

7 7 NovoMix® 30 offers simple convenient meal-time regimen – why? No waiting period after injection Can be taken with or after meal No overflow hypo (Premix analogue)

8 8 Simple convenient meal-time regimen  24-hour better physiological control –3 studies (vs. Mixtard, Lispro Mix, NPH) High safety Once-a-day dosing with OADs gives superior control FlexPen – Patient and prescriber acceptance (Premix analogue)

9 9 24h improved postprandial glucose after 3 months * Blood glucose (mmol/l) * 0 Pre Post- 8 6 NovoMix ® 30 Human Mixtard® 30 * p < 0.05 * * Lunch Pre-Post- Breakfast Pre-Post- Dinner Bedtime0200 h Boehm et al. Diabet Med 2002;19(5):393–9 European BIAsp 30 study group (Premix analogue) 12-wk, open-label comparison of NovoMix® 30 bd Vs Mixtard® 30 bd N= 294, T1 and T2 DM Study 1

10 10 NovoMix ® 30 produces significantly lower prandial glucose increment than H. Mixtard® NovoMix ® 30Human Mixtard® 30 Mean prandial glucose increment ( mmol/l) Boehm et al. Diabet Med 2002;19(5):393–399 p < 0.02 between treatment groups (n = 128) (n = 141) 1.66 mM 2.34 mM European BIAsp 30 study group (Premix analogue) 30% Study 1

11 11 NovoMix ® 30 produces significantly lower prandial glucose increment than Lispro Mix Hermansen K et al. Diabetes Care 2002;25:883–8 p < 0.05 –10% p < –17% Humalog ® Mix 25 TM NovoMix ® 30Human Mixtard® 30 Blood glucose excursion 0– 5h (mmol/l h) Randomized, crossover, 3-arm, single dose comparison with Lispro Mix and Human Mixtard®, T2DM, N=45 Study 2

12 12 Greater HbA 1c reduction with NovoMix ® 30 vs. NPH NovoMix ® 30 NPH Change in HbA 1c (%) p = 0.03 Christiansen et al. Diab Obes Met. 2003; 5(6) wk, double-blind, parallel comparison of NovoMix® 30 bd Vs NPH bd N= 403, T2 DM (Premix analogue) Study 3

13 13 NovoMix® 30 offers 24-hour better physiological control - Why? Significantly lower PG increment than human Mixtard® Significantly reduced HbA1c levels (Premix analogue)

14 14 Simple convenient meal-time regimen  24-hour better physiological control  High safety –3 studies Once-a-day dosing with OADs gives superior control FlexPen – Patient and prescriber acceptance (Premix analogue)

15 15 There were no reports of major hypoglycaemia during the trial Lesser number of minor hypoglycaemic episodes with NovoMix® 30 NovoMix ® 30 + met23 NovoMix ® 30 alone20 Met + SU 28 No other safety concerns were raised Hypo profile as safe as OADs Kvapil M et al. Diabetes 2002;51(Suppl 2):A wk, open-label comparison of NovoMix® 30, NM+Met, Met+SU N=329 (Premix analogue) Study 1

16 16 Low risk of nocturnal hypoglycemia (1) Number of hypoglycaemic episodes NovoMix ® 30Human Mixtard® events 20 events 50% relative risk reduction Boehm B et al. Diabet Med 2002;19(5):393–399 (n = 138) (n = 153) 12-wk, open-label comparison of NovoMix® 30 bd Vs Mixtard® 30 bd N= 294, T1 and T2 DM; RR hypo midnight-6 am = 0.62 (38% reduction) European BIAsp 30 study group (Premix analogue) Study 2

17 Low risk of nocturnal hypoglycemia (2) Boehm et al. Diabetologia 2001; 44 (Suppl 1): A st year 2nd year Year of study Patients with at least one major episode (%) p = NS p = 0.04 NovoMix ® 30 Human Mixtard® 30 2-year extension of European trial Only T2DM N=125 5% 8% 0% 10% On correct usage, major hypo can be avoided with NovoMix® 30 (Premix analogue) Study 3

18 18 NovoMix® 30 offers High safety – Why? Hypo profile as safe as OADs Reduced risk of between-meal hypo Low risk of nocturnal hypo (Premix analogue)

19 19 Simple convenient meal-time regimen  24-hour better physiological control  High safety  Once-a-day dosing with OADs gives superior control –2 studies (with Metformin; with glitazone) FlexPen – Patient and prescriber acceptance (Premix analogue)

20 20 Metformin combination Kilo C et al. J Diabetes Compl 2003; 17: Change in HbA 1c from baseline (%) NovoMix® 30 better glycemic control than Human Mixtard® 30 Insulin (+metformin) NovoMix ® 30NPHHuman Mixtard ® 30 US study, 25 centres, N=131, T2 DM, 12 wk 3-arm, open-label comparison of Metformin plus once-daily NM, Mixtard, NPH (Premix analogue) Study 1

21 21 Glitazone combination Raz I et al. Diabetologia 2003;46(Suppl 2):A8 HbA 1c (%) ScreeningVisit 6End of Trial NovoMix ® 30 NovoMix ® 30 + pioglitazone Glibenclamide + pioglitazone * * *p < 0.01 N=246, T2 DM OAD failure, 18 wk 3-arm, open-label comparison of NM+Pio, NM alone, SU+Pio Replace SU/SU+combn failures with NovoMix® 30+Pio in T2DM (Premix analogue) Study 2

22 22 NovoMix® 30 offers once-a-day dosing with OADs and gives superior control – Why? NovoMix® 30 better glycemic control than Human Mixtard® 30 when combined with OADs Replace SU/SU+combn failures with NovoMix® 30+Pio in T2DM (Premix analogue)

23 23 Simple convenient meal-time regimen  24-hour better physiological control  High safety  Once-a-day dosing with OADs gives superior control  FlexPen – Patient and prescriber acceptance –1 study (Premix analogue)

24 24 N=102 82% of healthcare professionals preferred FlexPen ® compared to two other prefilled pens 2 FlexPen ® Lilly pen 82% 14% 3% Aventis prefilled pen Patient and prescriber acceptance (1 ) % p<0.01 vs. Lilly pen and Aventis pen Lawton et al. Diabetes 2001; 50 (suppl 2): A440 (Premix analogue) Study 1

25 25 How can you say that NovoMix® 30 FlexPen enjoys patient and prescriber acceptance? Studies have shown that > 80% healthcare professionals preferred NovoMix FlexPen (Premix analogue)

26 26 Patient profile for NovoMix® 30 (Premix analogue)

27 27 NovoMix 30: What are the patient profiles? NM30 is suitable for following 3 sets of pts. Elderly (50 yrs) people with type 2 diabetes Uncontrolled diabetes in people on conventional insulins People with diabetes prone to or with fear of hypoglycemia

28 28 How to use NovoMix® 30? Initiation of NovoMix® 30: 1)0.2 U/kg/24 h 2)Split 2/3 morning, 1/3 evening 3)Keep OAD dose unchanged Switching from Human Mixtard  30 or NPH:Dose 1:1 (Premix analogue)

29 29 NovoMix 30: Kinetics Human Mixtard ® 30 within 30 minutes 2-8 hours 24 hours NovoMix ® minutes 1-4 hours 24 hours Onset of action Peak action Duration of action

30 30 NovoMix 30 vs. Glargine : New data

31 31 NovoMix 30 vs. Insulin Glargine (1) 1.NM30 provides both basal & prandial control (Glargine provides only basal control- controlling PPG is important) 2.NM 30 - mitogenicity similar to HI; Glargine – 8-fold increased mitogenicity 3.Retinopathy seen in some patients with type 2 diabetes in studies of 1 year or shorter Berger M. Lancet 2000;356: studies presented at ADA ‘04 -NovoMix 30 is superior to Glargine INITIATE study Luzio et al. study

32 32 NovoMix 30 vs. Insulin Glargine (2) INITIATE study INITIATE = INITiation of Insulin to reach A1c TargEt Twice daily NovoMix 30 vs. Bedtime Insulin Glargine Raskin et al. Diabetes June 2004; 53 (Suppl. 2): A143 Study highlights US multicentre, randomized, n=233 type 2 DM inadequately controlled on OAD Duration= 28 wk. OAD: Pts discontinued SUs, Stabilized on met If on glitazones, continued on Pio

33 33 NovoMix 30 vs. Insulin Glargine (3) NovoMix 30 is superior to Insulin Glargine 1.Better overall control - lower HbA1c 2.Better PPG control 3.More patients achieved target HbA1C of ≤ 6.5% or <7%

34 34 NovoMix 30 vs. insulin Glargine (4) Better PPG control than Glargine Raskin et al. Diabetes June 2004; 53 (Suppl. 2): A143 Before breakfast Breakfast +90 Before lunch Lunch +90 Before dinner Dinner +90 Bedtime 2 am

35 35 NovoMix 30 Vs. Insulin Glargine (5) HbA1c target More patients achieved target A1C with NM30 Raskin et al. Diabetes June 2004; 53 (Suppl. 2): A143 Patients reaching target at week 28 (%) 42% 28% 66% 40% p= p=0.0002

36 36 NovoMix 30 vs. Insulin Glargine (6) Luzio et al. NovoMix® 30 or glargine NovoMix® Time (h) Plasma Insulin (pM) NovoMix® 30 Glargine PI AUC 0-24h; p<0.01 Luzio et al. Diabetes June 2004; 53 (Suppl 2): A136 1.Compared PK & PD of NM 30 vs. Glargine 2.28% greater pl. insulin (AUC) 3. 34% greater glucose-lowering effect

37 37 NovoMix 30 Vs. Insulin Glargine (7) Luzio et al. Although equivalent doses of NM30 & Glargine were given: –28% greater plasma insulin (AUC) with NovoMix ® 30 –In contrast to Glargine that targets only basal control, NM targets clinically important PPG + good basal control –32% greater glucose-lowering effect with NovoMix ® 30

38 38 Once daily with OADs: New study

39 39 NovoMix: Once daily when initiated, enabled 42% to achieve target HbA1c (1) Jain et al.; presented at ADA ‘04 Phase 1 of 48 wk, multicenter trial Subjects not achieving targets on OAD with or without once daily basal insulin (NPH/Glargine) of the 92 patients, at 16 wks –23% (21) achieved A1C ≤ 6.5% –42% (39) achieved A1C < 7% –For subjects who achieved A1C ≤ 6.5%, mean A1C reduction was 2.4% BaselineAt 16 wks 8.5%6.1% 2.4% Jain et al. Diabetes June 2004; 53(Suppl. 2): A130 HbA1cHbA1c

40 40 NovoMix: Once daily when initiated, enabled 42% to achieve target HbA1c (2) 57% (n=53) 20% (n=18) 23% (n=21) HbA 1c ≤6.5% 6.5% < HbA 1c <7% HbA 1c ≥7% Jain et al. Diabetes June 2004;53( Suppl. 2):A130 23% patients reached HbA1c ≤6.5% with NovoMix® 30 OD 42%

41 41 High safety: 4 yr data

42 42 NovoMix 30: High safety (4 yr data)- (1) HypoglycaemiaNovoMix 30Mixtard 30 At least 1 major episode 411 Major Nocturnal 06 Minor Nocturnal 511 Extension of 3 m European BIAsp 30 study; n=73 with type 2; 4 yr data on safety vs. Mixtard 30 Boehm et al. Diabetologia 2003; 46(Suppl 2):A269 3 findings Significantly less no. of hypoglycaemic episodes No major nocturnal episode with NM 30 (6 episodes with Mixtard 30) Confirms - with proper use of NovoMix 30, nocturnal hypoglycaemia can be avoided

43 43 NovoMix 30: High safety (4 yr data)- (2) Major Episodes Minor episodes 4 years of study Number of Nocturnal Episodes p = 0.02 p = events 11 events >50% 0 6 events No major nocturnal episode with NM 30 Boehm B et al. Diabetologia 2003; 46(Suppl 2):A269

44 44 Simple convenient meal-time regimen (3 studies) –Comparison of pre & post meal (elderly) (Warren or Albery et al.) –Pre & post meal vs. Mixtard (at or 15 min before meal) (Kapitza et al) –Mixtard (at or 30 min before meal) (Hermansen et al. 2002) 24-hour better physiological control –vs. Mixtard (Boehm et al slides) –vs. Lispro Mix & Mixtard (Hermansen et al. 2002) –vs. NPH (Christiansen et al. 2003)

45 45 High safety (3 studies) –as safe as OADs (Kvapil et al) –Low risk of nocturnal hypo Boehm et al (12 wk study) Boehm et al. (2 yr study) Once-a-day dosing with OADs gives superior control (2 studies) –Metformin combination (Kilo et al. 2003) –Glitazone combination (Raz et al. 2003) FlexPen – Patient and prescriber acceptance (1 study) –Lawton et al.

46 Insulin initiation made safer and simpler (Premix analogue)


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