Page 560 - fbkCardioDiabetes_2017

536 Initiation & Intensification of Insulin Therapy in T2DM

Highlights

FIX FASTING FIRST 1 CONSISTENT EFFICACY 2
22.2 Lantus ® with or without Metformin
Baseline Week 12 Week 24
⊗ (12 wk): –1.5 –1.1 –1.6 –2.0 –1.1 –1.5
16.6 ⊗ (24 wk): 8.5 –1.7 8.5 –1.3 8.6 –1.9 9.4 –2.4 9.2 –1.5 8.7 –1.7
10
Glucose (mmol/L) 11.1 Type 2 diabetes Mean A1C (%) 7.5 5 7 6.8 7.4 7.2 7 6.7 7.4 7 8.1 7.7 7.2 7

5.5
2.5
Normal
0
0600 1000 1400 1800 2200 0200 0600 0
Time of day EASIE L2T3 INSIGHT 4020 4022 Pooled
SAFETY – HYPOGLYCAEMIA 2 LONG-TERM SAFETY
4
Unadjusted pooled event rates of overall,
nocturnal, and severe hypoglycaemia at Lantus ® had a neutral effect on CV
Episodes per patient-year 2 Week 12 Epidemiology Lantus ® is not associated with
Week 12 and Week 24 with Lantus ® with or
3
outcomes and cancer incidence 3
3
3
without Metformin
Week 24
0.9 0.9
1
0.7 0.7
women, prostate cancer in man, and
0.2 0.3 Programme an increased risk of breast cancer in
Northern European,
colorectal cancer in men and women 4–
0.1 0.1
0 US Databases & ISICA 7
PG cut-off Overall Nocturnal Severe
(mmol/L) < 3.9 < 3.1 < 3.9 < 3.1 < 2.0
1. Courtesy of Dr Jay Skyler, adapted from Polonsky KS, et al, N Engl J Med 1988;318:
1231–9; 2. Owens DR, et al. Diabetes Technol Ther 2013;15(suppl 1):A-88 [Abstract P-170]; 3.
ORIGIN Trial Investigators, et al. N Engl J Med 2012;367:319–28; 4. Boyle P. Oral presentation
at ADA 2012, Philadelphia, PA, USA. June 11, 2012; 5. Habel LA, et al. Diabetes Care
2013;36:3953–60; 6. Stürmer T, et al. Diabetes Care 2013;36:3517–25; 7. Grimaldi-Bensouda L,
et al. Diabetes Care 2014;37:134–43.
®
ORIGIN: a landmark Lantus trial
First ORIGIN data presented at ADA‘12: Label update in 2013
2012 The world’s longest and largest randomized Includes CV safety & efficacy
Lantus ® cardiovascular (CV) outcomes trial in data from ORIGIN
pre- and early diabetes 1*
Lantus ® does not alter the risk
ADA ’13: Assessing cognitive function, cancer for CV outcome vs
2013 safety, relationship of grip strength to CV risk standard of care
and also renal function No association with overall
ESC ’13: CV risk and hypoglycemia incidence and increased risk
of any cancer
ORIGIN sub-studies continue, e.g.:
• Hypoglycemia predictors Rates of severe hypoglycemia
2014 • Microvascular are very low
• Biomarkers
Provides long-term
ORIGINALE observational follow-up: glycemic control
To assess effects of Lantus ® and/or
n-3 PUFA on CV events / other outcomes
Results in a modest mean increase
in body weight
*12,500 patients with new or recently diagnosed diabetes with a high CV risk;
Treatment with Lantus ® or omega-3 FA; Over 6 or 7 years of follow-up
1. ORIGIN Trial Investigators, Gerstein HC, et al. N Engl J Med 2012;367(4):
319–28

GCDC 2017