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"Management of Hyperglycemia in T2DM: Update on

the New ADA-EASD Position Statement"

Silvio E. Inzucchi, M.D.

Yale University School of Medicine

Professor of Medicine

New ADA-EASD Type 2 Diabetes

Treatment Guidelines

July 13, 2012

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Silvio E. Inzucchi, M.D.

Yale University School of Medicine

Professor of Medicine

8

Silvio E. Inzucchi MD

Yale University

New ADA-EASD Type 2 Diabetes

Treatment Guidelines

insulin 1950 1960 1970 1980 1990 2000 2010 9 8 7 6 5 4 3 2 1 Nu mbe r of Med ica tion Cl asse s 10

11

_{Hypertension & Diabetes:}

Drug Classes* in U.S.

over Past Half-Century

Sulfonylureas Biguanides Angiotensin II receptor blockers ACE Inhibitors Ca+ channel blockers - blockers diuretics central -2 agonists peripheral -1 blockers adrenergic neuronal blockers Renin inhibitors vasodilators -glucosidase inhibitors Thiazolidinediones „Glinides GLP-1 Receptor Agonists DPP-4 inhibitors Amylinomimetics Biguanides Bile acid sequestrants Dopamine agonists

+

peripheral

glucose

uptake

hepatic

glucose

production

pancreatic

insulin

secretion

pancreatic

glucagon

secretion

Main Pathophysiological Defects in T2DM

gut

carbohydrate

delivery &

absorption

incretin

effect

HYPERGLYCEMIA

?

2008 ADA / EASD Consensus Algorithm

Nathan DM, et al. Diabetes Care. 2008;31:1

At Diagnosis:

Lifestyle +

Metformin _{Lifestyle + Metformin}

+ Sulfonylureaa Lifestyle + Metformin + Basal Insulin Lifestyle + Metformin + Intensive Insulin Lifestyle + Metformin + Pioglitazone Lifestyle + Metformin + GLP-1 agonistb Lifestyle + Metformin + Basal Insulin Lifestyle + Metformin + Pioglitazone + Sulfonylureaa

STEP 1

STEP 2

STEP 3

Tier 2: Less well-validated therapies Tier 1: Well-validated therapies

Reinforce lifestyle changes at every visit and check A1C every 3 months until < 7.0%, then at least every 6 months thereafter. Change interventions whenever A1C ≥ 7.0%.

a_{Sulfonylureas other than glibenclamide (glyburide) or chlorpropamide.} b_{Insufficient clinical use to be confident regarding safety.}

MET TZD 2 DPP4 1 AGI 3 A1C 6.5 – 7.5%** Monotherapy MET + GLP-1 or DPP4 1 TZD 2 Glinide or SU 5 TZD + GLP-1 or DPP4 1 MET + Colesevelam AGI 3 2 - 3 Mos.*** 2 - 3 Mos.*** 2 - 3 Mos.*** Dual Therapy MET + DPP4 _{or GLP-1} 1,10 or TZD2 SU or Glinide 4,5 A1C 7.5 – 9.0% Dual Therapy 8 2 - 3 Mos.*** 2 - 3 Mos.*** Triple Therapy 9 MET + GLP-1 or DPP4 1 + TZD 2 Glinide or SU 4,7 MET + GLP-1 or DPP4 1 + TZD 2 GLP-1 or DPP41 + SU 7 TZD 2 A1C > 9.0% No Symptoms

Drug Naive Under Treatment

INSULIN ± Other Agent(s) 6 Symptoms INSULIN ± Other Agent(s) 6 INSULIN ± Other Agent(s) 6 Triple Therapy

AGI α-Glucosidase Inhibitor

DPP4 DPP-4 Inhibitor

GLP-1 Incretin Mimetic

Met Metformin

SU Sulfonylurea

TZD Thiazolidinedione FPG Fasting Plasma Glucose PPG Post-prandial Glucose A1C Goal ≤ 6.5%* MET + GLP-1 or DPP4 1 ± SU 7 TZD 2 GLP-1 or DPP4 1 ± TZD 2

Rodbard H et al. Endocrine Practice 2009

* _{May not be appropriate for all patients} ** _{For patients with diabetes and A1C< 6.5,}

pharmacologic Rx may be considered

*** _{If A1C goal not achieved safely}

1 _{DPP4 if PPG and FBG or GLP-1 if}

PPG

2 _{TZD if metabolic syndrome (MetS) and/or}

non-alcoholic fatty liver disease (NAFLD)

3 _{AGI if PPG}

4 _{Glinide if PPG or SU if FBG} 5 _{Low dose secretagogue recommended} 6 _{a) Discontinue insulin secretagogue with}

multidose insulin b) Can use pramlintide with prandial insulin.

7 _{Decrease secretagogue by 50% when added}

to GLP-1 or DPP-4

8 _{If A1c <8.5, combination Rx with agents that}

cause hypoglycemia should be used with caution

9 _{If A1c> 8.5, in patients on Dual Therapy,}

insulin should be considered

10 _{GLP-1 not approved for initial combination Rx} INSULIN

± Other Agent(s) 6

HbA_1c≥7.5%1 HbA 1c <7.5%1 Monitor HbA_1c≥7.5%1 HbA 1c <7.5%1 Monitor

HbA_1c≥6.5%1 _{after lifestyle trial}

Metformin2 HbA_1c ≥ 6.5%1 _HbA

1c<6.5%1

Monitor

Add insulin2,8

(esp. if very hyperglycemic) Insulin + Metformin + SU4

1 _{Or individually agreed target.}

2 _{With active dose titration.}

3 _{See the NICE clinical guideline on obesity (www.nice.org.uk/CG43).}

4 _{Offer once-daily sulfonylurea if adherence is a problem.}

5 _{Only continue DPP-4 inhibitor or thiazolidinedione if reduction in HbA}

1c

of at least 0.5 percentage points in 6 months.

6 _{Only continue exenatide if reduction in HbA}

1c of at least 1 percentage point

and weight loss of at least 3% of initial body weight at 6 months.

Consider SU4 if:

• Not overweight3, or

• Metformin is not tolerated or contraindicated, or

• Rapid therapeutic response needed due to hyperglycemic symptoms. Consider glinide for people with erratic lifestyles.

Consider substituting DPP-4i9 or TZD10 for SU if significant risk of hypo-

glycemia (or its consequences) or SU contraindicated / not tolerated. Consider DPP-4i9 or TZD10 instead of insulin if insulin unacceptable (due to

employment, social, recreational, or other personal issues) Consider adding exenatide6 if:

•BMI ≥35, European descent7, & problems associated with high weight, or

•BMI <35 kg/m2 _{& insulin unacceptable because of occupational implications or}

weight loss would benefit other comorbidities. Increase insulin dose & intensify regimen over time. Consider pioglitazone with insulin if:

• A TZD has previously had a marked glucose-lowering effect, or

• BG control is inadequate with high-dose insulin.

Metformin +SU4

National Institute for

Health and Clinical

Excellence (NICE)

TYPE 2 DIABETES

National clinical guideline for

management in primary &

secondary care (2009)

HbA_1c ≥ 7.5%1 HbA 1c< 7.5%1 Monitor HbA_1c≥7.5%1 HbA_1c <7.5%1 Monitor HbA_1c≥7.5%1 _HbA 1c <7.5%1 Monitor

Consider adding DPP-4i9 _{or TZD}10

if metformin contraindicated or not tolerated

HbA_1c ≥ 6.5%1 HbA_1c<6.5%1

Monitor

Sulfonylurea4

Metformin2 _+DPP-4i5,9 _{or + TZD}5,10

7 _{With adjustment for other ethnic}

groups.

8 _{Continue with metformin and}

sulfonylurea (and acarbose, if used), but only continue other drugs that are licensed for use with insulin. Review the use of sulfonylurea if hypoglycemia occurs. 9 _{DPP-4 inhibitor refers to} sitagliptin or vidagliptin. 10 _{Thiazolidinedione refers to} pioglitazone or rosiglitazone. SU4 _+DPP-4i5,9 _{or + TZD}5,10 HbA_1c≥7.5%1 HbA_1c <7.5%1 Monitor Metformin2 _{+ SU}4 _{+ DPP4i}5_{, or} Metformin2 _{+ SU}4 _{+ TZD}5, 10_{, or} Metformin2 _{+ SU}4 _{+ GLP-1R agonist}6 Start insulin2,8

National Institute for

Health and Clinical

Excellence (NICE

)

TYPE 2 DIABETES

National clinical guideline for

management in primary &

secondary care (2009)

Did We

Really

Need Another Guideline ?

1. Increasing number & variety of anti-hyperglycemic

agents.

2. New data re: benefits vs. risks of tight glycemic control.

3. Increasing concerns about drug safety.

4. Increasing discourse about personalized medicine and

‘patient

-

centered’ care.

5. Prior guidelines were consensus documents that did

not undergo formal Association review to become an

2010

2011

2012

ADA

EASD

Invitations Draft Revisions

Literature Review

S O N D J F M A M J J A S O N D J

2012

EASD

S O N D J F M A M J

ADA-EASD Position Statement: Timeline

Hard copy publication Revisions Draft 5.4 to 25 Experts

Expert

Review

2011

PPC & POGS

Review

Exec Comms.

Review

Management of Hyperglycemia in Type 2

Diabetes: A Patient-Centered Approach

Position Statement of the American Diabetes Association (ADA) and

the European Association for the Study of Diabetes (EASD)

Diabetes Care 2012;35:1364–1379

Writing Group

American Diabetes Association Richard M. Bergenstal MD

Int’l Diabetes Center, Minneapolis, MN

John B. Buse MD, PhD

University of North Carolina, Chapel Hill, NC

Anne L. Peters MD

Univ. of Southern California, Los Angeles, CA

Richard Wender MD

Thomas Jefferson University, Philadelphia, PA

Silvio E. Inzucchi MD (co-chair)

Yale University, New Haven, CT

European Assoc. for the Study of Diabetes Michaela Diamant MD, PhD

VU University, Amsterdam, The Netherlands

Ele Ferrannini MD

University of Pisa, Pisa, Italy

Michael Nauck MD

Diabeteszentrum, Bad Lauterberg, Germany

Apostolos Tsapas MD, PhD

Aristotle University, Thessaloniki, Greece

David R. Matthews MD, DPhil (co-chair)

ADA-EASD Position Statement: Management of

Hyperglycemia in T2DM: A Patient-Centered Approach

1. PATIENT-CENTERED APPROACH

2. BACKGROUND

•

•

•

3. ANTIHYPERGLYCEMIC TX

•

•

- Lifestyle

- OAD s& non-insulin injectables - Insulin

•

- Initial drug therapy

- Advancing to dual combination tx - Advancing to triple combination tx - Transitions to / titrations of insulin

4. OTHER CONSIDERATIONS

• Age

•

•

•

Disease, Hypoglycemia)

5. FUTURE DIRECTIONS /

RESEARCH NEEDS

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

1. Patient-Centered Approach

“

...

providing care that is respectful of and responsive to

individual patient preferences, needs, and values - ensuring

that patient values guide all clinical decisions.”

•

Gauge patient’s preferred level of involvement.

•

Shared decision making

–

final decisions re: lifestyle choices

ultimately lies with the patient.

•

Explore, where possible, therapeutic choices.

•

Utilize decision aids.

Diabetes Care 2012;35:1364–1379

“We Need Minimally Disruptive Medicine”

The burden of treatment for many

people with complex, chronic,

comorbidities reduces their capacity

to collaborate in their care.

4 Principles

1. Establish the weight of burden.

2. Encourage coordination in

clinical practice.

3. Acknowledge comorbidity in

clinical evidence.

4. Prioritize from the

patient

perspective.

Impact of Intensive Therapy for Diabetes:

Summary of Major Clinical Trials

Study

Microvasc

CVD

Mortality

UKPDS













DCCT / EDIC*













ACCORD







ADVANCE







VADT







Long Term Follow-up Initial Trial

* in T1DM

Kendall DM, Bergenstal RM. © International Diabetes Center 2009

UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854.

Holman RR et al. N Engl J Med. 2008;359:1577. DCCT Research Group. N Engl J Med 1993;329;977.

Nathan DM et al. N Engl J Med. 2005;353:2643. Gerstein HC et al. N Engl J Med. 2008;358:2545. Patel A et al.N Engl J Med 2008;358:2560. Duckworth W et al. N Engl J Med 2009;360:129. (erratum: Moritz T. NEnglJMed 2009;361:1024)

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

3. ANTI-HYPERGLYCEMIC THERAPY

•

Glycemic targets

-

HbA1c < 7.0%

(mean PG 150-160

mg/dl

[8.3-8.9

mmol/l

])

-

Pre-prandial PG <130

mg/dl

(7.2

mmol/l

)

-

Post-prandial PG <180

mg/dl

(10.0

mmol/l

)

-

Individualization

is key:



_{Tighter targets (6.0 - 6.5%) - younger, healthier}



Looser targets (7.5 - 8.0%

+

) - older, comorbidities,

hypoglycemia prone, etc.

-

Avoidance of hypoglycemia

Most Intensive Less Intensive Least Intensive

Patient Age

Disease Duration

Other Comorbidities

None Few/Mild Multiple/Severe

Hypoglycemia Risk

Low Moderate High

8.0%

6.0%

7.0%

Established Vascular Complications

None

Early Micro Advanced Micro

Psychosocioeconomic Considerations

Highly Motivated, Adherent, Knowledgeable,

Excellent Self-Care Capacities, & Comprehensive Support Systems

Less motivated, Non-adherent, Limited insight, Poor Self-Care Capacities,

& Weak Support Systems

Cardiovascular

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

3. ANTI-HYPERGLYCEMIC THERAPY

•

Therapeutic options: Lifestyle

-

Weight optimization

-

Healthy diet

-

Increased activity level

Diabetes Care 2012;35:1364–1379

Class

Mechanism

Advantages

Disadvantages

Cost

• Closes KATP channels

• Insulin secretion • Extensive experience • Microvascular risk • Hypoglycemia • Weight gain • Low durability • ? Ischemic preconditioning Low TZDs • Activates PPAR- • Insulin sensitivity • No hypoglycemia • Durability • TGs, HDL-C • ? CVD events (pio) • Weight gain

• Edema / heart failure

• Bone fractures

• ? MI (rosi)

• ? Bladder ca (pio)

High

-GIs • Inhibits -glucosidase

• Slows carbohydrate absorption • No hypoglycemia • Nonsystemic • Post-prandial glucose • ? CVD events • Gastrointestinal • Dosing frequency • Modest A1c Mod.

Class

Mechanism

Advantages

Disadvantages Cost

• ? Beta cell mass

• ? CV protection • GI • ? Pancreatitis • Medullary ca • Injectable High Amylin mimetics

• Activates amylin receptor

• glucagon • gastric emptying • satiety • Weight loss • Post-prandial glucose • GI • Modest A1c • Injectable • Hypo w/ insulin • Dosing frequency High Bile acid sequestrants

• Binds bile acids

• Hepatic glucose production • No hypoglycemia • Nonsystemic • LDL-C • GI • Modest A1c • TGs • Dosing frequency High Dopamine-2 agonists • Activates DA receptor • Modulates hypothalamic control of metabolism • Insulin sensitivity • No hypoglycemia • ? CVD events • Modest A1c • Dizziness/syncope • Nausea • Fatigue High

Class

Mechanism

Advantages

Disadvantages

Cost

Insulin • Activates insulin

receptor • Glucose disposal • Hepatic glucose production • Universally effective • Unlimited efficacy • Microvascular risk • Hypoglycemia • Weight gain • ? Mitogenicity • Injectable • Training requirements • “Stigma” Variable

©2011 by American College of Physicians

Figure 1. Pooled between-group differences in HbA1c level

with monotherapy and combination therapies

140 head-to-head trials+26 observational studies of mono, combo therapy with intermed./ long-term clinical outcomes and harms reported

Bennett WL, et al. Ann Intern Med 2011;154:602

Agency for Healthcare Research & Quality:

©2011 by American College of Physicians

Figure 2. Pooled between-group difference in body weight

with monotherapy and combination therapies

Bennett WL, et al. Ann Intern Med 2011;154:602

Agency for Healthcare Research & Quality:

©2011 by American College of Physicians

Figure 4. Pooled odds of mild or moderate hypoglycemia

with monotherapy and combination therapies.

Agency for Healthcare Research & Quality:

Comparative Effectiveness & Safety of T2DM Medications

Bennett WL, et al. Ann Intern Med 2011;154:602

“

Evidence on long-term clinical outcomes

(all-cause

mortality, cardiovascular disease, nephropathy, and

neuropathy)

was of low strength or insufficient. Most

medications decreased A1c level by about 1% and most

2-drug combinations produced similar reductions.”

“Evidence supports

metformin as a first-line

agent to treat

T2DM. Most 2-drug combinations similarly reduce A1c

levels, but some increased risk for hypoglycemia and other

adverse events.”

Diabetes Care 2012;35:1364–1379

Diabetes Care 2012;35:1364–1379

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Age: Older adults

-

Reduced life expectancy

-

Higher CVD burden

-

Reduced GFR

-

At risk for adverse events from polypharmacy

-

More likely to be compromised from hypoglycemia



Less ambitious targets



HbA1c <7.5

–

8.0% if tighter targets

not easily achieved



Focus on drug safety

Diabetes Care 2012;35:1364–1379

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Weight

-

Majority of T2DM patients overweight / obese

-

Intensive lifestyle program

-

Metformin

-

GLP-1 receptor agonists

-

? Bariatric surgery

-

Consider LADA in lean patients

Diabetes Care 2012;35:1364–1379

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Sex/ethnic/racial/genetic differences

-

Little is known

-

MODY & other monogenic forms of diabetes

-

Latinos: more insulin resistance

-

East Asians: more beta cell dysfunction

-

Gender may drive concerns about adverse effects

(e.g., bone loss from TZDs)

Diabetes Care 2012;35:1364–1379

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Comorbidities

-

Coronary Disease

-

Heart Failure

-

Renal disease

-

Liver dysfunction

-

Hypoglycemia



Metformin: CVD benefit (UKPDS)



Avoid hypoglycemia



_{? SUs & ischemic preconditioning}



? Pioglitazone &

CVD events



? Effects of incretin-based

therapies

Diabetes Care 2012;35:1364–1379

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Comorbidities

-

Coronary Disease

-

Heart Failure

-

Renal disease

-

Liver dysfunction

-

Hypoglycemia



Metformin: May use unless

condition is unstable or severe



Avoid TZDs



? Effects of incretin-based

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Comorbidities

-

Coronary Disease

-

Heart Failure

-

Renal disease

-

Liver dysfunction

-

Hypoglycemia



Increased risk of hypoglycemia



Metformin & lactic acidosis



_{US: stop}

SCr

≥ 1.5 (1.4 women)



_{UK: half-dose}

GFR < 45 &

stop

GFR < 30



Caution with SUs (esp. glyburide)



DPP-4-

i’s –

dose adjust for most

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Comorbidities

-

Coronary Disease

-

Heart Failure

-

Renal disease

-

Liver dysfunction

-

Hypoglycemia



_{Most drugs not tested in advanced}

liver disease



Pioglitazone may help steatosis

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

4. OTHER CONSIDERATIONS

•

Comorbidities

-

Coronary Disease

-

Heart Failure

-

Renal disease

-

Liver dysfunction

-

Hypoglycemia



Emerging concerns regarding

association with

increased

morbidity / mortality



_{Proper drug selection is key in}

Guidelines for Glucose, BP, & Lipid Control

American Diabetes Assoc. Goals

HbA1C

< 7.0%

(individualization)

Preprandial

glucose

70-130

mg/dL (3.9-7.2 mmol/l)

Postprandial

glucose

< 180

mg/dL

Blood pressure

< 130/80

mmHg

Lipids

LDL: < 100

mg/dL (2.59 mmol/l)

< 70

mg/dL (1.81 mmol/l)

(with overt CVD)

HDL: > 40

mg/dL (1.04 mmol/l)

> 50

mg/dL (1.30 mmol/l)

TG: < 150

mg/dL (1.69 mmol/l)

ADA. Diabetes Care 2012;35:S11–S63 HDL = high-density lipoprotein; LDL = low-density

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

KEY POINTS

•

Glycemic targets & BG-lowering therapies must be individualized.

•

Diet, exercise, & education: foundation of any T2DM therapy program

•

Unless contraindicated, metformin = optimal 1st-line drug.

•

After metformin, data are limited. Combination therapy with 1-2 other

oral / injectable agents is reasonable; minimize side effects.

•

Ultimately, many patients will require insulin therapy alone / in

combination with other agents to maintain BG control.

•

All treatment decisions should be made in conjunction with the patient

(focus on preferences, needs & values.)

•

Comprehensive CV risk reduction - a major focus of therapy.

Diabetes Care 2012;35:1364–1379

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

Contrasts to 2008 ADA-EASD Treatment Algorithm

•

Not as prescriptive / algorithmic

•

Calibration of treatment targets to patient needs

•

Acknowledgement of the role of lifestyle change

prior

to

metformin (in selected patients)

•

Individualization of treatment options

•

Harmonization of 5 dual therapy options

after

metformin

•

Recognition of role for initial combination therapy (A1c>9%)

•

Endorsement of triple therapy, when required

ADA-EASD Position Statement: Management of Hyperglycemia in T2DM

Invited Reviewers

Professional Practice Committee, American Diabetes Association

Panel for Overseeing Guidelines and Statements, European Association for the Study of Diabetes American Association of Diabetes Educators

The Endocrine Society American College of Physicians James Best, The University of Melbourne, Australia

Henk Bilo, Isala Clinics, Zwolle, Netherlands

John Boltri, Wayne State University, Detroit, MI

Thomas Buchanan, Univ of So California, LA, CA

Paul Callaway, University of Kansas,Wichita, KS

Bernard Charbonnel, University of Nantes, France

Stephen Colagiuri, The University of Sydney, Australia

Samuel Dagogo-Jack, Univ of Tenn, Memphis, TN

Margo Farber, Detroit Medical Center, Detroit, MI

Cynthia Fritschi, University of Illinois, Chicago, IL

Rowan Hillson, Hillingdon Hospital, Uxbridge, U.K.

Faramarz Ismail-Beigi, CWR Univ, Cleveland, OH

Devan Kansagara, Oregon H&S Univ, Portland, OR

Ilias Migdalis, NIMTS Hospital, Athens, Greece

Donna Miller, Univ of So California, LA, CA

Robert Ratner, MedStar/Georgetown Univ, DC

Julio Rosenstock, Dallas Diab/Endo Ctr, Dallas, TX

Guntram Schernthaner, Rudolfstiftung Hosp, Vienna, Austria

Robert Sherwin, Yale University, New Haven, CT

Jay Skyler, University of Miami, Miami, FL

Geralyn Spollett, Yale University, New Haven, CT

Ellie Strock, Int’l Diabetes Center, Minneapolis, MN

Agathocles Tsatsoulis, University of Ioannina, Greece

Andrew Wolf, Univ of Virginia Charlottesville, VA

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