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ENDOCRINE PRACTICE Rapid Electronic Article in Press

Rapid Electronic Articles in Press are preprinted manuscripts that have been accepted for publication in an issue of

Endocrine Practice

AACE/ACE COMPREHENSIVE
DIABETES MANAGEMENT
ALGORITHM
2015
TA S K F OR CE
Alan J. Garber, MD, PhD, FACE, Chair

Martin J. Abrahamson, MD George Grunberger, MD, FACP, FACE


Joshua I. Barzilay, MD, FACE Yehuda Handelsman, MD, FACP, FNLA, FACE
Lawrence Blonde, MD, FACP, FACE Irl B. Hirsch, MD
Zachary T. Bloomgarden, MD, MACE Paul S. Jellinger, MD, MACE
Michael A. Bush, MD Janet B. McGill, MD, FACE
Samuel Dagogo-Jack, MD, DM, FRCP, FACE Jeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNU
Michael B. Davidson, DO, FACE Paul D. Rosenblit, MD, PhD, FNLA, FACE
Daniel Einhorn, MD, FACP, FACE Guillermo Umpierrez, MD, FACP, FACE
Jeffrey R. Garber, MD, FACP, FACE Michael H. Davidson, MD, Advisor
W. Timothy Garvey, MD, FACE

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This material is protected by US copyright law. For permission to reused material in any format, complete a permission form
at www.aace.com/permissions. To purchase reprints of this article, please visit: www.aace.com/reprints. DOI:10.4158/EP15693.CS
Copyright © 2015 AACE.
TABLE OF CONTENTS

Com pr e he n si v e Di abe t e s
A lg orit h m
I. Complications-Centric
Model for Care of the
Overweight/Obese Patient

II. Prediabetes Algorithm

III. Goals of Glycemic Control

IV. Glycemic Control Algorithm

V. Algorithm for
Adding/Intensifying Insulin

VI. CVD Risk Factor


Modifications Algorithm

VII. Profiles of Antidiabetic


Medications

VIII. Principles for Treatment


of Type 2 Diabetes

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Complications-Centric Model for Care
of the Overweight/Obese Patient

STEP 1 E VA L U AT I O N F O R C O M P L I C AT I O N S A N D S TA G I N G

C A RD IOM E TA B OL IC D ISEASE B IOMECHANIC AL COMP LIC AT IONS

NO CO MPL IC ATIONS B M I ≥ 2 7 WI TH COM P LI C ATI ON S

BMI 25–26.9, Stage Severity of Complications


or BMI ≥ 27
LOW MEDIUM HIGH

Therapeutic targets for Treatment Treatment intensity for weight


STEP 2 SELEC T: improvement in complications + modality + loss based on staging

Lifestyle Modification: MD/RD counseling; web/remote program; structured multidisciplinary program

phentermine; orlistat; lorcaserin; phentermine/topiramate ER;


Medical Therapy:
naltrexone/bupropion; liraglutide

Surgical Therapy (BMI ≥ 35): Lap band; gastric sleeve; gastric bypass

If therapeutic targets for improvements in complications not met, intensify lifestyle and/or medical
STEP 3 and/or surgical treatment modalities for greater weight loss

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PR EDIABETES ALGORITH M
IFG (1 00– 1 2 5) | IG T ( 140–199) | ME TAB OLIC SYN D R OM E (NCE P 2005 )

L I F E S T Y L E M O D I F I C AT I O N
(Including Medically Assisted Weight Loss)

OT HE R C V D W EI GHT LOSS ANTIHYPE R GLYCE MIC T H E R AP IE S


R ISK FAC TORS T HER APIES FPG > 100 | 2-hour PG > 140

C V D R ISK FAC TOR N ORMA L 1 PRE-DM MU LTIPL E PR E- DM


M OD IF IC ATI ON S ALGOR ITH M G LYC E M I A C RI TE RI ON CR ITER IA

DYSL IPIDE MIA HYPE R TE NSION Low-risk Consider with


ROUTE ROUTE Medications Caution
Progression Intensify
Weight Metformin TZD
Loss
Therapies Acarbose GLP-1 RA
OV E R T
D I A B E TE S

PR OCE E D TO
HYPER G LYCEMI A If glycemia not normalized,
ALG OR I T HM consider with caution

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G OALS FOR G LYCE MIC CONT R OL

IN DIVIDUA LIZ E G OA LS

A1c ≤ 6.5% A1c > 6.5%


For patients without For patients with
concurrent serious concurrent serious
illness and at low illness and at risk
hypoglycemic risk for hypoglycemia

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Glyc em ic Con t r ol A lg or it hm

L I F E S T Y L E M O D I F I C AT I O N
(Including Medically Assisted Weight Loss)

Entry A1c < 7.5% Entry A1c ≥ 7.5% Entry A1c > 9.0%

M O NO T H E R A PY* S YMPTO MS
Metformin D UA L TH ER APY*
NO YES
GLP-1 RA T R I PL E TH ER APY*
GLP-1 RA
SGLT-2i GLP-1 RA DUAL INSULIN
SGLT-2i
Therapy ±
DPP-4i SGLT-2i
DPP-4i Other
MET TZD MET OR Agents
AGi TZD
or other or other
1st-line Basal Insulin 1st-line TRIPLE
TZD Basal insulin
agent agent + Therapy
Colesevelam 2nd-line DPP-4i
SU/GLN
agent
+ Bromocriptine QR Colesevelam
AGi Bromocriptine QR
SU/GLN
+ AGi A DD O R I NTENS I FY
If not at goal in 3 months
SU/GLN
I NS UL I N
If not at goal
proceed to Double Therapy Refer to Insulin Algorithm
in 3 months
proceed to If not at goal in
Triple Therapy 3 months proceed Few adverse events
to or intensify LEGEND or possible benefits
insulin therapy Use with caution
* Order of medications listed represents a suggested hierarchy of usage

P R O G R E S S I O N O F D I S E A S E
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ALGORITHM FOR ADDING/INTENSIF Y ING INSULIN

S T A R T B A S A L (long-acting insulin) I N T E N S I F Y (prandial control)

A1c < 8% A1c > 8% Add GLP-1 RA Add Prandial Insulin


or SGLT-2i
or DPP-4i
TDD 0.1–0.2 U/kg TDD 0.2–0.3 U/kg TDD 0.3–0.5 U/kg
t #BTBM"OBMPH
Glycemic t 1SBOEJBM"OBMPH
Insulin titration every 2–3 days
Control Not t -FTTEFTJSBCMF/1)
to reach glycemic goal:
at Goal**  BOESFHVMBSJOTVMJO
t 'JYFESFHJNFO*ODSFBTF5%%CZ6  PSQSFNJYFEJOTVMJO
t "EKVTUBCMFSFHJNFO
t FBG NHE-BEEPG5%%
t FBG oNHE-BEEPG5%%
t FBG oNHE-BEE6OJU
t *GIZQPHMZDFNJB SFEVDF5%%CZ
t #(NHE-o
t #(NHE-o

Consider discontinuing or reducing sulfonylurea after Insulin titration every 2–3 days to reach glycemic goal:
basal insulin started (basal analogs preferred to NPH)
t *ODSFBTFQSBOEJBMEPTFCZGPSBOZNFBMJGUIFIS
 QPTUQSBOEJBMPSOFYUQSFNFBMHMVDPTFJTNHE-
**Glycemic Goal: t 1SFNJYFE*ODSFBTF5%%CZJGGBTUJOHQSFNFBM#(NHE-
t *GGBTUJOH".IZQPHMZDFNJB SFEVDFCBTBMJOTVMJO
t GPSNPTUQBUJFOUTXJUI5%.GBTUJOHBOEQSFNFBM t *GOJHIUUJNFIZQPHMZDFNJB SFEVDFCBTBMBOEPSQSFTVQQFSPS
 #(NHE-BCTFODFPGIZQPHMZDFNJB  QSFFWFOJOHTOBDLTIPSUSBQJEBDUJOHJOTVMJO
t "DBOE'#(UBSHFUTNBZCFBEKVTUFECBTFEPOQBUJFOUT t *GCFUXFFONFBMEBZUJNFIZQPHMZDFNJB SFEVDFQSFWJPVT
 BHF EVSBUJPOPGEJBCFUFT QSFTFODFPGDPNPSCJEJUJFT  QSFNFBMTIPSUSBQJEBDUJOHJOTVMJO
 EJBCFUJDDPNQMJDBUJPOT BOEIZQPHMZDFNJBSJTL

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CVD R ISK FA CTOR M ODIFICATIONS ALGORITHM

DYSLIPIDEMIA HYPERTENSION

THERAPEUTIC LIFESTYLE CHANGES (See Obesity Algorithm)

L IPID PA N EL: Assess CVD Risk G OAL : SYSTOL IC ~130,


DIASTOL IC ~80 mm Hg

If TG > 500 mg/dL, fibrates, omega-3 ACEi For initial blood pressure
STATIN TH E R A PY ethyl esters, niacin or >150/100 mm Hg:
If statin-intolerant ARB D UAL THER APY

Try alternate statin, lower statin Repeat lipid panel; Intensify therapies to Thiazide
dose or frequency, or add nonstatin assess adequacy, attain goals according ACEi Calcium
LDL-C- lowering therapies tolerance of therapy to risk levels
or Channel
Blocker
DM but no other major risk DM + major CVD risk(s) (HTN, Fam Hx,
ARB
RISK LE VELS MODERATE and/or age <40 HIGH low HDL-C, smoking) or CVD* ß-blocker
DESIRABLE LEVELS DESIRABLE LEVELS
LDL-C (mg/dL) <100 <70
If not at goal (2–3 months)
Non-HDL-C (mg/dL) <130 <100
TG (mg/dL) <150 <150 Add ß-blocker or calcium channel
TC/HDL-C <3.5 <3.0 blocker or thiazide diuretic
Apo B (mg/dL) <90 <80
LDL-P (nmol/L) <1200 <1000 If not at goal (2–3 months)

Add next agent from the above


Intensify TLC (weight loss, physical activity, dietary changes)
IF NOT AT DESIRABLE LEVELS: group, repeat
and glycemic control; Consider additional therapy
If not at goal (2–3 months)

TO LOWER LDL-C: Intensify statin, add ezetimibe &/or colesevelam &/or niacin Additional choices (α-blockers,
TO LOWER Non-HDL-C, TG: Intensify statin &/or add OM3EE &/or fibrates &/or niacin central agents, vasodilators,
TO LOWER Apo B, LDL-P: Intensify statin &/or ezetimibe &/or colesevelam &/or niacin spironolactone)

Assess adequacy & tolerance of therapy with focused laboratory evaluations and patient follow-up Achievement of target blood
pressure is critical
* E V EN MORE IN TEN SI V E T HER APY MI GHT BE WAR R ANT ED

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PR OFI LES OF ANTIDIA BETIC M EDICAT IONS

MET GLP-1 RA SGLT-2i DPP-4i AGi TZD SU COLSVL BCR-QR INSULIN PRAML
GLN
Moderate/
Severe Moderate
HYPO Neutral Neutral Neutral Neutral Neutral Neutral Neutral Neutral Neutral
Mild to Severe

Slight
WEIGHT Loss Loss Neutral Neutral Gain Gain Neutral Neutral Gain Loss
Loss

Dose
Contra-
Exenatide Adjustment May More
indicated Genital More
RENAL/ Contra- May be Worsen Hypo Risk
CKD Mycotic Neutral Hypo Neutral Neutral Neutral
GU indicated Necessary Fluid & Fluid
Stage Infections Risk
CrCl < 30 (Except Retention Retention
3B,4,5
Linagliptin))

GI Sx Moderate Moderate Neutral Neutral Moderate Neutral Neutral Mild Moderate Neutral Moderate

CHF Neutral Neutral Moderate Neutral Neutral


Neutral Neutral Neutral Neutral Neutral Neutral
Increased
CVD Benefit Neutral ? Safe
LDL

Moderate
BONE Neutral Neutral Neutral Neutral Neutral Bone Neutral Neutral Neutral Neutral Neutral
Loss

Few adverse events or possible benefits Use with caution Likelihood of adverse effects

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PR INCIPLES OF THE AACE ALGORITHM
F OR THE TR EATMENT OF T YPE 2 DIA BE TE S

1) Lifestyle optimization and education are essential cations that affect their choice include: risk of the clinician as well as to guide therapy at the
for all patients with diabetes. Lifestyle modifica- inducing hypoglycemia, risk of weight gain, point of care.
tion designed for weight loss, including medical ease of use, cost, and safety impact of kidney, 13) The algorithm should conform, as nearly as pos-
and surgical interventions approved for the treat- heart, or liver disease. This algorithm includes sible, to a consensus for current standard of
ment of obesity, should be considered as primary every FDA-approved class of medications for practice of care by expert endocrinologists who
approaches for therapeutic benefits in over- diabetes. This algorithm also stratifies choice specialize in the management of patients with
weight and obese patients with diabetes, and for of therapies based on initial A1c. type 2 diabetes and have the broadest experi-
prevention of diabetes in high risk patients with 7) The algorithm provides guidance to what thera- ence in outpatient clinical practice.
prediabetes. The treatment of overweight/obe- pies to initiate and add, but respects individual 14) The algorithm should be as specific as possible,
sity in patients with type 2 diabetes and predia- circumstances that would make different choices. and provide guidance to the physician with
betes should proceed according to the Obesity 8) Therapies with complementary mechanisms of prioritization and a rationale for selection of
Treatment Algorithm. Effective interventions for action must typically be used in combinations any particular regimen.
weight loss involve a multidisciplinary team. The for optimum glycemic control. 15) Rapid-acting insulin analogs are superior to Reg-
need for medical therapy for weight loss or glyce- 9) Effectiveness of therapy must be evaluated fre- ular because they are more predictable.
mic control should not be considered as a failure quently until stable (e.g. every 3 months) using 16) Long-acting insulin analogs are superior to NPH
of lifestyle management, but as an adjunct to it. multiple criteria including A1c, SMBG records insulin because they provide a fairly flat re-
2) The A1c target must be individualized, based on including both fasting and post-prandial data, sponse for approximately 24 hours and provide
numerous factors, such as age, comorbid condi- documented and suspected hypoglycemia, and better reproducibility and consistency both be-
tions, duration of diabetes, risk of hypoglycemia, monitoring for other potential adverse events tween subjects and within subjects, with a corre-
patient motivation, adherence, life expectancy, (weight gain, fluid retention, hepatic, renal, or sponding reduction in the risk of hypoglycemia.
etc. An A1c of 6.5% or less is still considered opti- cardiac disease), and monitoring of comorbidi-
mal if it can be achieved in a safe and affordable ties, relevant laboratory data, concomitant drug
manner, but higher targets may be appropriate administration, diabetic complications, and psy- This document represents the official position of the
American Association of Clinical Endocrinologists and
and may change in a given individual over time. cho-social factors affecting patient care.
the American College of Endocrinology. Where there
3) Minimizing risk of hypoglycemia is a priority. It is 10) Safety and efficacy should be given higher prior-
were no RCTs or specific FDA labeling for issues in clin-
a matter of safety, adherence, and cost. ities than initial acquisition cost of medications ical practice, the participating clinical experts utilized
4) Minimizing risk of weight gain is a priority. It too per se since cost of medications is only a small their judgment and experience. Every effort was made
is a matter of safety, adherence, and cost. part of the total cost of care of diabetes. In deter- to achieve consensus among the committee mem-
5) Glycemic control targets include fasting and mining the cost of a medication, consideration bers. Many details that could not be included in the
postprandial glucose as determined by self should be given to monitoring requirements, graphic summary (Figure) are described in the text.
blood glucose monitoring. risk of hypoglycemia and weight gain, etc.
6) The choice of therapies must be individualized 11) The algorithm should be as simple as possible to
based on attributes of the patient (as above) gain physician acceptance and improve its utility All necessary author disclosures are made to AACE and are on
and the medications themselves (see Profiles of and usability in clinical practice. file at the main office. Please contact Lori Clawges at AACE for
Antidiabetic Medications). Attributes of medi- 12) The algorithm should serve to help educate further inquiries.

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