established and novel pharmacological therapies for type 2 diabetes mcgill first canadian summit on...
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Established and Novel Pharmacological Therapies
for Type 2 Diabetes
McGill First Canadian Summit onSurgery for Type 2 Diabetes
Montréal, QuébecMay 6, 2010
David C.W. Lau, MD, PhD, FRCPCProfessor of Medicine and Biochemistry
Julia McFarlane Diabetes Research CentreUniversity of Calgary
Email: [email protected]
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Disclosures
• Research funding:CIHR, AHFMR, Alberta Cancer Board, AstraZeneca, BMS, Dainippon, GSK, Eli Lilly, Pfizer and sanofi-aventis
• Consultant or advisory board member: Abbott, Allergan, AstraZeneca, Bayer, Boehringer-Ingelheim, GSK, Eli Lilly, Merck, Novartis, Novo Nordisk, Pfizer, Roche, sanofi-aventis, Sepracor
• Speaker bureau:CDA, HSFC, AstraZeneca, Abbott, Bayer, Boehringer-Ingelheim, Eli Lilly, GSK, Merck, Novo Nordisk, Pfizer sanofi-aventis and Sepracor
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Overview
• Glycemic control and vascular complications • Pathophysiology of type 2 diabetes• 2008 CDA Clinical Practice Guidelines on the
management of type 2 diabetes• Pharmacotherapy for type 2 diabetes• Novel and emerging therapies for type 2 diabetes
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1 Fong DS, et al. Diabetes Care. 2003; 26 [Suppl. 1]:S99–S102.2 Molitch ME, et al. Diabetes Care. 2003; 26 [Suppl.1]:S94–S98.3 Kannel WB, et al. Am Heart J. 1990; 120:672–676.4 Gray RP & Yudkin JS. In Textbook of Diabetes. 1997.5 Mayfield JA, et al. Diabetes Care. 2003;26 [Suppl. 1]:S78–S79.
DiabeticretinopathyLeading causeof blindness in working-age adults1
DiabeticnephropathyLeading cause of end-stage renal disease2
Cardiovasculardisease
Stroke2- to 4-fold increase in cardiovascular mortality and stroke3
DiabeticneuropathyLeading cause of non-traumatic lower extremity amputations5
8/10 diabetic patients die from CV events4
Diabetes is a Serious Chronic Disease
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P Hossain et al. N Engl J Med 2007;356:213-215
Global Increase 180 472 million!
Global Prevalence of Diabetes in 2000 and Projections for 2030
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Obesity as the Major Cause of Diabetes
IDF. Diabetes Atlas. Second Edition 2003
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Glycemic Control and Complications
DCCT: Type 1 diabetes followed for 6.5 years A1C 7% versus 9% 60% reduction in microvascular
complications 1
DCCT-EDIC 17-year follow-up 57% reduction in major CVD outcomes 2
UKPDS: Type 2 diabetes followed for 10 yrs A1C 7% versus 7.9% 25% reduction in microvascular
complications 3
Each 1% decrease in A1C ~30% reduction in microvascular complications in both Type 1 and Type 2 diabetes
1. DCCT Research Group. N Engl J Med 1993;329:977-862. DCCT/EDIC Research Group. N Engl J Med 2005;353:2643-533. Holman RR et al. N Engl J Med 2008;359:1577-1589
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UKPDS: Long-term Glycemic ControlCross-sectional, median values
UKPDS, Lancet 1998;352:837-853
06
7
8
9
0 3 6 9 12 15
HbA
1c (
%)
Years from randomisation
Conventional
Intensive
6.2% upper limit of normal range
8
A1C
7
Years 2 6 10
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Stratton IM, et al. UKPDS 35. BMJ 2000;321:405–12
Perc
enta
ge in
crea
se in
rela
tive
risk
corr
espo
ndin
g to
a 1
% ri
se in
HbA
1C
**
Any diabetes-related
endpoint
21%
**
Diabetes-related death
21% **
All cause
mortality
14%*
Stroke
12%
**
Peripheral vascular disease†
43%
**
Myocardial infarction
14%
**
Micro-vascular disease
37%
**
Cataract extraction
19%
† Lower extremity amputation or fatal PVD* P = 0.035; **P < 0.0001
UKPDS 35: Decreased Risk of Diabetes-related complications with 1% in A1C
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Glucose Lowering (A1C 0.9%) and Non-fatal MIs
Ray KK et al. Lancet 2009;373:1765-1672
17%
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Glucose Lowering (A1C 0.9%) and CAD
Ray KK et al. Lancet 2009;373:1765-1672
15%
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The (DCCT/EDIC) Study Research Group. N Engl J Med 2005;353:2643-2653
DCCT/EDIC in DM1: 17-yearCumulative Incidence of First CV Event
Legacy effect; benefit of
early aggressive glycemic control on
CVD outcomes
DCCT/EDIC Research Group. N Engl J Med 2005;353:2643-53
ACE42%
CVD
57%
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Holman RR, et al. N Engl J Med 2008;359:1577-1589
UKPDS 10-year Follow-up:Kaplan-Meier Curves for Outcomes
Legacy effect; benefit of
early aggressive glycemic control on
CVD outcomes
Holman RR, et al. N Engl J Med 2008;359:1577-1589
Ins-SU
End-pt9%
MI15%
Micro24%
Death13%
Met
End-pt21%
MI33%
MicroNS
Death27%
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STENO-2 13-year Follow-up:Kaplan-Meier Curves of the Risk of Death and CV Events
All cause 45%
CVD
57%
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Defining Glycemic Control
Parameter Target Rationale
A1C ≤ 7% (0.070 lab value)
A1C levels >7% are associated with significantly increased risk of microvascular and macrovascular complications
FPG 4.0–7.0 mmol/L FPG levels are a major contributor to A1C values of >8.5%
2h PPG 5.0–10.0 mmol/L(or 5.0–8.0 mmol/L)
In A1C levels approaching ≤7%, there is a greater contribution from postprandial glucose levels; if A1C targets are not met, lowering PPG to 5.0–8.0 mmol/L can be considered
2008 CDA CPGs. Can J Diabetes 2008;32(Suppl 1):S29–S31
A1C = glycated hemoglobin FPG = fasting plasma glucose PPG = postprandial plasma glucose
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Targets for Glycemic Control
• In most people with type 1 or type 2 diabetes, A1C ≤ 7% should be targeted to reduce microvascular complications [Grade A, Level 1A]
• In type 2 diabetes, A1C ≤ 6.5% may be considered to further lower the risk of nephropathy [Grade A, Level 1A]
Can J Diabetes 2008;32(Suppl 1):S29-S31
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Intestine:Glucose Absorption
Liver: Glucose Production
Muscle
Fat
PeripheralGlucoseUptake
Pancreas
InsulinSecretion
+
- +
Brain &Nervous System
BLOOD GLUCOSE
Control of Blood Glucose
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Diminishedinsulin
HyperglycemiaLiver
1. Insulin deficiency
2. Excess glucose output 3. Insulin resistance
Pancreas
Muscle and fat
Excess glucagon
Islet
Diminishedinsulin
α-cell produces excess glucagon
β-cell produces less insulin
Pathophysiology of Type 2 DiabetesThree Main Defects
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Adapted from Williams G, Pickup JC, eds. Handbook of Diabetes, 3rd ed. Malden, MA: Blackwell Publishing, 2004. DeFronzo RA. Ann Intern Med. 1999;131:281–303; Buse JB, et al. In: Williams Textbook of Endocrinology. 10th ed. Philadelphia: Saunders, 2003;1427–1483.
Pancreatic β-cells Sulfonylureas, meglitinides
↑ insulin release
Gut
α-glucosidase inhibitors glucose
absorption
Muscle
Liver
Biguanides Thiazolidinediones
Insulin glucose production
ThiazolidinedionesBiguanides
Insulin ↑ glucose uptake
Oral Anti-diabetic agents: Mechanisms of action
Amelioration of hyperglycemia
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Insulin Secretion Profiles in Type 2 Diabetes and Non-Diabetic Subjects
K Polonsky et al. New Engl J Med 318:1231-1239, 1998
Pa
ncre
atic
Insu
lin S
ecr
etio
n (
pm
ol/m
in)
Clock Time (hours)
No Diabetes
Type 2 diabetes
Meals (9 am, 1pm, 6pm)
800
700
600
500
400
300
200
100
6:00 am 10:00 2:00 pm 6:00 10:00 2:00 am
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β-ce
ll fu
nctio
n (%
)
Years
100
75
50
25
00 1 2 3 4 5 6
β-cell function declines, while . . .
UK Prospective Diabetes Study Group. Diabetes 1995;44:1249–1258
Years0 1 2 3 4 5 6
9
10
8
7
6
5
HbA
1C
. . . hyperglycemiaincreases
Progressive Impairment in β-cell FunctionDiet/conventional Rx (n=376)Metformin (n=159)Sulfonylurea/intensive (n=511)
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Food intake
Stomach
GI tract
Intestine
Increases and prolongs GLP-1 effect on alpha-cells:
Alpha-cells
Pancreas
Insulin release
Net effect: Blood glucose
Beta-cells
Increases and prolongs GLP-1 and GIP effects on beta-cells:
DPP-4 inhibitor
Glucagon secretion
Incretins
DPP-4
DPP-4 Inhibitors Enhance Incretin and Insulin Secretion
Adapted from: Barnett A. Int J Clin Pract 2006;60:1454-70 Drucker DJ, Nauck MA. Nature 2006;368:1696-705Idris I, Donnelly R. Diabetes Obes Metab 2007;9:153-65
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Lifestyle Intervention
A1C ≥9%
• Initiate pharmacotherapy immediately
• Consider initiating metformin concurrently with another agent from a different class;
• Initiate insulin
Symptomatic hyperglycemia with metabolic decompensation
Initiate insulin ± metformin
A1C <9%
Initiatemetformin
If not at target
2008 CDA CPGs. Can J Diabetes 2008;32(Suppl 1):S1–201
2008 CDA CPGs Treatment Algorithm
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Initiate metformin
Initiate pharmacotherapy immediately without waiting for effect from lifestyle interventions: Consider initiating metformin concurrently with another agent from a different class; or insulin Initiate insulin
± metformin
If not at target
Add an agent best suited to the individual:
• Alpha-glucosidase inhibitor
• Incretin agent: DPP-4 inhibitor
• Insulin
• Insulin secretagogue: Meglitinide, Sulfonylurea
• TZD
• Weight loss agent
If not at target:
• Add another drug from a different class; or
• Add bedtime basal insulin to other agent(s); or
• Intensify insulin therapy
2008 CDA Clinical Practice GuidelinesClinical Assessment - Lifestyle intervention (Nutrition therapy and physical activity)
A1C < 9.0% A1C ≥ 9.0% Symptomatic hyperglycemia with metabolic decompensation
2008 CDA CPGs. Can J Diabetes 2008;32(Suppl 1):S53–S61
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2008 CDA CPGs. Can J Diabetes 2008;32(suppl 1):S53-S61
* Less hypoglycemia in the context of missed meals
2008 CDA Clinical Practice Guidelines:Drug Therapy for Type 2 Diabetes
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0 6 12 18 24 30 38 46 54 62 70 78 91 1046
6.5
7
7.5
8
8.5
9
Sitagliptin and Metformin Combination Therapy
24-Week Phase Continuation Phase Extension Phase
A1C
(LS
mea
n ch
ange
%)
Time (weeks)Sita 100 mg qd (n=50) Met 500 mg bid (n=64)
Met 1000 mg bid (n=87) Sita 50 mg bid + Met 500 mg b.i.d. (n=96)
Sita 50 mg bid + Met 1000 mg bid (n=105)
Adapted from Qi Daniel S, et al. 73-OR, EASD 2008Sita = sitagliptin; Met = metformin
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Exenatide Monotherapy:A1C Change from Baseline
0
-1.2
-1.0
-0.8
-0.6
-0.4
-0.2
0.04 8 12 16 24
Study Week
LS M
ean
(SE
)
in A
1C (
%)
*
*
*
*
*
*
*
*
ITT patients. Analysis using mixed-models repeated measures. Mean baseline A1C values (%): exenatide 5 g: 7.9%;exenatide 10 g: 7.8%; placebo: 7.8%. *P ≤ 0.001 vs. placebo. ITT=intent-to-treat. LS=least-squares. SE=standard error.
Adapted from Moretto TJ, et al. Clin Ther. 2008;30(9):1448-1460.
Exenatide 5 µg (n=76)Exenatide 10 µg (n=76)Placebo (n=75)
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Exenatide Monotherapy: Weight Change from Baseline
-4.0
-3.5
-3.0
-2.5
-2.0
-1.5
-1.0
-0.5
0.00 4 8 12 16 24
LS M
ean
(SE
)
in W
eigh
t (kg
)
Study Week
†
*
†
*
*
*
Exenatide 5 µg (n=77)Exenatide 10 µg (n=76)Placebo (n=76)
ITT patients. Analysis using mixed-model repeated measures. Mean baseline weights: 85 to 86 kg.Statistical comparisons are vs. placebo. *P ≤ 0.007. †P ≤ 0.027. ITT=intent-to-treat. LS=least-squares. SE=standard error
Adapted from Moretto TJ, et al. Clin Ther. 2008;30(9):1448-1460.
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Kahn SE et al. N Engl J Med 2006;355:2427-2443
ADOPT: Kaplan-Meier Estimates of the Cumulative Incidence of Monotherapy Failure at 5 Years
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SGLT2 Inhibitor
• Sodium–glucose cotransporter-2 (SGLT2) reabsorbs glucose in the proximal tubule
• Dapagliflozin induces glucosuria by inhibiting sodium–glucose cotransporter-2
• Insulin-independent glucose lowering
• Lowers A1C by 0.6-0.8%• 2-3% body weight loss
Komoroski B et al. Clinical Pharm & Therapeutics 2009;85:513–519
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Glucokinase Activators
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Glucokinase Activators
• Glucokinase serves as a glucose sensor of the pancreatic islet β cells‐
• Controls the conversion of glucose to glycogen in the liver and regulates hepatic glucose production
• Lowers glucose by stimulating insulin release and glucose uptake in liver
• Can be used in combination with other OHAsMatchinski F Nature Rev Drug Discovery 2009;8;399-416
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Pharmacotherapy for Type 2 Diabetes
• Glycemic control is an integral component of optimal diabetes management
• Metabolic control also reduces cardiovascular disease risk in people with diabetes
• Availability of effective and safe drugs that lower glucose without significant adverse effects will add to current armamentarium
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Thank you
Questions?