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Robert E. Ratner, MD Chief Scientific and Medical Chief Scientific and Medical Officer Normal Threshold Plasma Glucose Levels for Activation of Counterregulation and Symptoms B: Neuroglycopenic B: Neuroglycopenic A: Autonomic symptoms A:

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Robert E. Ratner, MD Chief Scientific and Medical Chief Scientific and Medical Officer

B C A

A: Autonomic symptoms A: Autonomic symptoms B: Neuroglycopenic B: Neuroglycopenic symptoms symptoms C: Cognitive dysfunction C: Cognitive dysfunction

Normal Threshold Plasma Glucose Levels for Activation of Counterregulation and Symptoms

Glucagon Epinephrine Pancreatic Polypeptide Growth Hormone Suppression of Insulin Secretion 30 40 50 60 70 80 90 Norepinephrine Cortisol Glucagon

Glycemic Threshold (arterial glucose, mg/dL)

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Risk Factors for Severe Hypoglycemia

 Low HbA1c

1c

 Factors interfering with counterregulation  Increases of insulin sensitivity  Changes in drug metabolism

I d t t iti

 Inadequate nutrition  Other medical conditions (e.g., impaired

cognition)

How Often Does Hypoglycemia Occur in Diabetes?

90 100

%

Daily to about 1/wk 1/mo to several times/mo

64.5 24.9 23.5 34.9 12 40.2

20 30 40 50 60 70 80 90

equency of NSHE, %

/ / Only a few times/y or very rarely

NSHE, nonsevere hypoglycemic events. Survey 409 US patients with T1DM (n = 200) and with T2DM (n = 209). Brod M, et al. Value Health. 2011;14:665-671.

12

10 20

T1DM T2DM Fre

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When Does Hypoglycemia Occur With Diabetes?

Awake and at work Awake but not at work

30% 50% 20%

During sleep at night

Brod M, et al. Value Health. 2011;14:665-671.

50%

1/5 of all nonsevere hypoglycemia occurs nocturnally

NSHE, nonsevere hypoglycemic events. Survey 409 US patients with T1DM (n = 200) and with T2DM (n = 209).

All Hypoglycemia Negatively Affects Quality of Life in Patients With T2DM

Alvarez-Guisasola1 (N = 1709; 38% with events) Marrett2 (N = 1984; 63% with events)

−2.68 −6.42 −16.09

  • 25
  • 20
  • 15
  • 10
  • 5

RQoL Decrement

a a a −0.01 −0.06 −0.13 −0.21

  • 0.25
  • 0.2
  • 0.15
  • 0.1
  • 0.05

RQoL Decrement

a a a

a P < .05 vs no reported hypoglycemia.

  • 1. Alvarez-Guisasola F, et al. Health Qual Life Outcomes. 2010;8:86.
  • 2. Marrett E, et al. BMC Res Notes. 2011;4:251.
  • 3. Williams S, et al. Diabetes Res Clin Pract. 2011;91:363-370.

HR

Hypoglycemia Severity

HR

Hypoglycemia Severity Hypoglycemia is also associated with lower treatment satisfaction, poorer adherence, and greater resource utlization3

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Severe Hypoglycemia Is Associated With Increased Risk of Mortality and CV Events

Macrovascular events 3.45 (2.34-5.08); P < .001 Death—any cause 3.30 (2.31-4.72); P < .001 ADVANCE Trial Results1

0.1 1 10

3.30 (2.31 4.72); P .001 Death—non-CV cause 2.86 (1.67-4.90); P < .001 Death—CV cause 3.78 (2.34-6.11); P < .001 Macrovascular events 1.88 (1.03-3.34); P = .04 Death—any cause 6.37 (2.57-15.79); P =

VADT Results2

  • 1. Zoungas S, et al; ADVANCE Collaborative Group. N Engl J Med. 2010;363:1410-1418.
  • 2. Duckworth W, et al; VADT Investigators. VA Diabetes Trial (VADT) update. ADA 70th Scientific Sessions. 2010:

http://webcasts.prous.com/netadmin/webcast_viewer/Preview.aspx?type=0&lid=9473&pv=2&preview=False&idcl=0.

0.1 1 10 Hazard Ratio (95% CI)

6.37 (2.57 15.79); P .0001 Death—CV cause 3.73 (1.34-10.36); P = .0117

Increased Risk Decreased Risk 180 200 65-74

Hypoglycemia, by Age

70 72 121 141 126 152 60 80 100 120 140 160 180 75-84 ≥85

Rate per 100,000 Patient-Years

70 20 40 60

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

8 Year

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Hospitalization for Hyperglycemia and Hypoglycemia

114 130 140 114 70 94 105 40 60 80 100 120 Hyperglycemia

Rate per 100,000 Patient-Years

9 20

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Year Hyperglycemia Hypoglycemia

Adjusted for Diabetes Prevalence

820

800 900

367 676 612

200 300 400 500 600 700 800

Rate per 100,000 Patient-Years with Diabetes 10

100 200

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Year Hyperglycemia Hypoglycemia

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Hypoglycemia Hospitalizations as % of All-Cause T1DM and T2DM Hospitalizations

6.4% 7.0% 3.4% 3.0% 4.0% 5.0% 6.0% 0.0% 1.0% 2.0% T1DM T2DM

Length of Stay

T1DM patients with hypoglycemia stayed longer compared to those with all-cause hospitalizations

7 2

8

4.6 5.0 7.2

4 5 6 7

  • f stay in days

All-cause Hospitalizations Type 1 Diabetes hospitalizations length of stay

1 2 3

Length o

length of stay Hypoglycemia Hospitalizations in Type 1 Diabetes

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Charges for Hospitalizations with Hypoglycemia in T1DM (US$ per admission)

$46 039 $60,000 $46,039 $33,564 $30,655 $20,000 $30,000 $40,000 $50,000

Charges

$0 $10,000 $20,000 Hypoglycemia in T1DM T1DM All-Cause Hospitalizations

National Bill : Total Charges for Hypoglycemia Hospitalizations in T1DM

  • Total hospitalizations = 20,839 (95% CI = 19,233 - 22,445)

Ch h it li ti $46 039 (CI $42 144 $49 934)

  • Charge per hospitalization = $46,039 (CI = $42,144-$49,934)
  • Total charges = $ 959,406,721
  • As a comparison, hypoglycemia hospitalizations in T2DM :
  • Total hospitalizations = 248,422 (CI = 234,321-262,523)
  • Ch

h it li ti $48 569 (CI $45 781

  • Charges per hospitalization = $48,569 (CI = $45,781-

$51,357)

  • Total charges = $ 12.07 billion
  • Average Charge of US All-Cause Hospitalization: $33,232