intensive insulin management and basal/bolus therapy

New Drugs and Devices: What is In

The Pipeline For Type 1 and Type 2

Diabetes

Steven V. Edelman, MD

Professor of Medicine

University of California San Diego School of Medicine

Veterans Affairs Medical Center

Founder and Director, Taking Control Of Your Diabetes, a 501(c)3

Not-for-Profit Organization

Type 1 Diabetes

Etiology

Screening and Prevention

Encapsulated islet cells

New glucagons

Artificial pancreas

SGLT1&2 inhibitors

Very smart apps

Pipeline Drugs And Devices Differ

Depending On What Type Of DiabetesType 2 Diabetes

Etiology

Screening and Prevention

Implantable GLP-1 RA

Oral GLP-1

Glucagon receptor antagonists

CGM for type 2 Diabetes

Most powerful therapy in type 2 diabetes!

Natural History and Cause

of Type 1 Diabetes Autoimmune condition

Genetic predisposition

Damage to the cells of the pancreas

Pre-diabetes Diabetes

Time = months to a few years

100% Insulin making cells of the pancreas

Putative Trigger

Immune System Dysfunction

Circulating Auto Antibodies (ICA, GAD)

Symptoms

Pettus J, Edelman SV. (2013) Adjunctive Therapies. In The American Diabetes Association/JDRF Type 1 Diabetes

Sourcebook (319-340). VA: American Diabetes Association

Screening: Looking

For Antibodies

Anyone up to age 45

and

with a 1st degree relative

with type 1 diabetes

TrialNet

Can We Prevent The ImmuneAttack On The Pancreas?

Taken from Viacyte.com

Viacyte Device

Stem

Amylin

BLOOD VESSEL

CELLSMEMBRANE

Using the Devices in Mice Controls Blood Sugars

0

100

200

300

400

500

600

-42 -14 14 42 70 98 126 154 182 210 238

Blo

od

Glu

co

se (

mg

/dL

)

Time (days post-implant)

STZ

No STZ

Insulin implants

STZ VC-01 blood glucose control by graft stable 5+ months

after VC-01 explant,return of blood glucose topre-implant levels

9

Cell survival and differentiation into beta-cells 12 weeks after implant

Appears safe and well-tolerated

Encaptra device appears to be immune protective as designed

Need to optimize engraftment as it relates to the foreign body response to the device

STEP ONE: Demonstrated

Differentiation Into Beta Cells and

Potential for Prolonged Cell Survival

Both: 12-week PEC-Encap in

T1D patient Bottom: dark brown

= Nkx6.1 immunoreactivity

marks endocrine cells

PEC-Encap week 1

Age at Diagnosis of T1D

Beck RW, Tamborlane WV, Bergenstal RM, Miller KM, Dubose SN, Hall CA.

The T1D Exchange Clinic Registry. J Clin Endocrinol Metab. 2012; 97:4383-9.

You can get type 1 diabetes

at any age!

➢ The most missed diagnosis in diabetes

➢ Type 1 diabetes can occur at anyage

➢ Slower beta-cell destruction (may respond briefly to oral agents)

➢ Typically does not have features of the Metabolic Syndrome

➢ Blood test positive for type 1 diabetes (GAD auto antibodies)

Latent Autoimmune Diabetes in Adults

(LADA)

Gary Hall Jr.Olympic Gold MedalistWorld Record Holder

Edelman SV. Taking control of your diabetes: a patient oriented book on diabetes.

Fourth Edition Professional Communications Inc., Greenwich, CT. 544 pages, 2013.

Edelman SV, Henry RR. Diagnosis and management of type 2 diabetes.

12th Edition. Professional Communications, Inc., Greenwich, CT. 288 pages, 2014.

My Story with Type 1 Diabetes

Diagnosed at the age of 15

(1970) with the classic

symptoms

Thirst

Urination

Weight loss

Poor wound healing

Blurry vision

Fatigue

Edelman SV. Taking control of your diabetes: a patient oriented book on diabetes. Fifth

Edition Professional Communications Inc., Greenwich, CT. , 2018.

My Story With Type 1 Diabetes

No one in my family had type 1 diabetes

I was sent home from the hospital on one shot of insulin a day (NPH/Reg)

Urine testing only

No A1c test

No pumps or pens

No insulin analogs

No CGM

Edelman SV. Taking control of your diabetes: a patient oriented book on diabetes. Fifth


Banting and Best

University of Toronto, 1921

Jacobs. Diabetes Care. 1997; 20:1279.

Time (h)

22.00 3.00 7.00 8.00 9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00 18.00 19.00

1000

500

250

0

750

LisPro Regular

Serum Insulin Levels in Type 1 Diabetes

breakfast lunch dinner

Jacobs. Diabetes Care. 1997;20: 1279.

(mm

ol/

l)

Do

in

mg

/dL

15

10

5

0

Time (h)

22.00 3.00 7.00 8.00 9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00 18.00 19.00

*p < 0.05

Blood Glucose Levels

breakfast lunch dinner

Lispro Regular

Avg A1c=6.8

90

180

270

Subcutaneous Insulin Has A Very

Narrow Therapeutic Window

Too little insulin leads to postprandial hyperglycemia

Too much leads to hypoglycemia

Very difficult to get it just right

HypoglycemiaHyperglycemia

Insulin DoseEdelman SV. Taking control of your diabetes: a patient oriented book on diabetes. Fifth


Physiologic Insulin, Glucagon and

Amylin Secretion

LiverPancreas

Portal Vein

Systemic Circulation

InsulinAmylin

Glucagon

Beta Cell

Alpha Cell

Pettus J, Edelman SV. (2013) Adjunctive Therapies. In The American Diabetes

Association/JDRF Type 1 Diabetes Sourcebook (319-340). VA: American Diabetes Association

Inhaled Insulin (Afrezza)

Santos Cavaiola T, Edelman SV. Inhaled insulin: A breath of fresh air? A review of inhaled insulin. Clinical Therapeutics. 2014. 36(8)

Rapid on

Rapid off

• Better post meal glucose

values• Less delayed hypoglycemia

Faster Acting Aspart or Fiasp(addition of L-arginine and niacinamide for faster absorption)

Bode et al DTT Vol 19 2017

2 hour PG levels in

T1D onPump

therapy after a

standarized meal

comparing Aspart

(Novolog)with

Faster Aspert

(Fiasp)

Xeris ready-to-use liquid glucagon for

treatment of severe hypoglycemia

Translates to a strong value proposition:

Auto-injector delivery

◦ Ultra-compact design

◦ Simple, two-step operation

◦ Integrated safety features

Pre-filled syringe delivery preferred in some market segments

Superior caregiver/patient experience

◦ Reduced time to administration

◦ Increased likelihood of successful administration

◦ Reduced anxiety

Treatment of severe hypoglycemia –

as per current GEK labelIndication

• 0.5 and 1.0 mg of glucagon

• Pediatric and adult populationsDosing

• SC delivery

• SHL “Molly” auto-injector

− Auto-inject and auto-retract

− ‘Lock-out’ safety needle

– 1 - 2 second hold down time

(labeled at 5 seconds)

• Pre-filled syringe option also

available

Drug

Delivery

Devices

2 years at room temperatureStorage

Could a ready-to-use liquid glucagon

help address unmet need?

Lilly

Will There Be Adjustable Sizes? What is desirable: Contextual

awareness

Utilization of the sensors commonly found in today’s smartphones to tie BG to:

Location – GPS

Activity◦ Accelerometer

◦ Gyroscope

Time – day – date◦ Clock

◦ Calendar

Courtesy of

mHealthSys, Inc.

BG, blood glucose

Unmet needs – wireless sensor data

aggregation with multivariate

analytics• Wirelessly interfaced metabolic

sensors

• Aggregation and multivariate

analytics provide deeper insights Activity

BP

HR

Weight, body

fat

Courtesy of

mHealthSys, Inc.

Blood Glucose

Activity

Meals/Food Intake

Food intake

Activity

Glucose

BP, blood pressure; HR, heart rate

Courtesy of

mHealthSys, Inc.

Unmet needs –

automatic food recognition

Suggested portions

Estimate CHO, protein and fat

Recommended dose & testing schedule

Postprandial BG prediction

CHO, carbohydrate

Integrated system

Food type

Volume Carbs

Breaded 110 ml 11 g

Rice 120 ml 16.4 g

Salad 80 ml 2.6 g

Captured image

3D model

80 ml

120m

l

110 ml

Segmentation

CHO estimation Recognition

SaladRice

Breaded

Bolus Calculator

Smartphone server side

Plate detection

Mougiakakou S, et al. Diabetes Tech Ther 2015:17(Suppl. 1);A126 Abstract

285

Scan Your Plate With Your Smart Phone App!Basal/Bolus or MDI Insulin Regimen

With Rapid and Long-Acting

Analogs/Inhaled Insulin

4:00 16:00 20:00 24:00 4:00

Breakfast Lunch Dinner

8:0012:008:00

Time

Insu

lin

Acti

on

GlulisineOr

AspartOr

FiaspOr

Lisproor

Inhaled InsulinU-100/U-300

Glargine/Detemir) Degludec

Adapted with permission from Leahy J. In: Leahy J, Cefalu W, eds. Insulin Therapy. New York: Marcel Dekker; 2002:87-112. Nathan DM.

N Engl J Med 2002;347:1342-1349.

BOLUS

Basal

Smart Pens For You MDI

(Multiple Daily Injection) Folks

Works On The

iPhone XI I

38

Artificial Panreas

Tandem t:slim G5/X2

Medtronic 630/670G/530G

OmniPod

Insulin Pumps

Edelman SV. Taking control of your diabetes: a patient oriented book on diabetes.

Fourth Edition Professional Communications Inc., Greenwich, CT. 544 pages, 2013.

530G/630G/670G

Enlite by Medtronic

Dexcom G4

& G5

Platinum

Continuous Glucose Monitoring Devices Currently Available In The United States

How CGM and Trending Information

Can Affect Our Decisions (CF/I:CHO)

Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body

weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgraduate Medicine. 123(3), 2013.

G5 Dexcom Now Connects Directly to the

Smart Phone and Apple Watch Smart Phone

Clarity App

Mean glucose value

Standard Deviation

Time in Range

24 hour multiday

profile

An Artificial Pancreas Is Coming Faster

Than We Thought Possible

BG

mg/dL

Time

180

70

50

Alarm –

impending

hypoNo response –

alarm plus insulin

reduction or

off/glucagon on if

needed

Alarm –

impending

hyper

No response – alarm plus

automated insulin push

to bring level below

threshold(glucagon off)

Resume preset basal rate

Minimize time

in “Red” zones

iLet • BigFoot • Tandem • Insulet • Medtronic

How does the Auto mode feature work?AUTOMATED BASAL INSULIN DELIVERY

Auto Mode:

▪ 48 hours before it kicks in▪ Delivers automated basal insulin

doses every 5 minutes▪ Automated basal target = 120 mg/dL▪ Temporary target of 150 mg/dL can

be used

Bolusing & Meals

▪ Must enter blood glucose (BG) readings and/or carbohydrate grams

670G

HYBTID

Closed Loop

Important to Understand

what it can and cannot do This is a basal rate modulator

Works well overnight

Still requires meal boluses, correction bolus, and many fingersticks

Diabetes tasks during the day are not decreased

There are more alarms

Glucose

670G Study Subject Download

Average glucose = 153 (eA1c = 7.5%), 1% of readings < 70

mg/dl

D.I.Y.

SYSTEM

Old Medt.

Pump

iPhone

Riley Loop

Always in automode

Current BS-Blue

Predicted dotted line-Blue

How much insulin orange

(Example 6 extra units last hour)

Bars above and below baseline

Exercise targets

Cut out hypos almost completely

No lows at night

More time in range

iLet: Bionic Pancreas

2 ports for

insulin and glucagon

CGM Readings On and Off the Bionic Pancreas

Eversense

Implantable CGM (under FDA review)

“Other” Therapies for People

with Type 1 Diabetes

Symlin

Incretins (GLP-1 RA)*

SGLT-2 Inhibitors*

Inhaled Insulin

*Medications approved only type 2 diabetes at the current time

Sotagliflozin: First-in-Class Dual

SGLT1 and SGLT2 Inhibitor

SGLT1 is the primary transporter for absorption of glucose and galactose in the GI tract

SGLT2 is expressed in the kidney, where it reabsorbs 90% of filtered glucose

SGLT 1 SGLT 2

GI, gastrointestinal; SGLT, sodium-dependent glucose transporter Diabetes Care. 2015; 38(7):1181-8.

A1C and Hypoglycemia:T1D

Sotagliflozin significantly reduced mean A1C compared with placebo after 29 days with no increase in hypoglycemia

Change in A1C

-0.06

-0.55

-0.6

-0.5

-0.4

-0.3

-0.2

-0.1

0

Placebo Sotagliflozin

Ch

an

ge

fro

m b

ase

lin

e (

%)

*

*P = 0.002 relative to

placebo

-0.4

-0.7

-0.8

-0.7

-0.6

-0.5

-0.4

-0.3

-0.2

-0.1

0


Ch

an

ge

fro

m b

ase

lin

e (

PP

D)

Change in number of hypoglycemic events (SMBG

≤70 mg/dL), per patient per day (PPD)

Multiple events for a patient were each counted

SMBG, self-monitoring of blood

glucose

Diabetes Care. 2015; 38(7):1181-8.

Body Weight T1D

Patients treated with sotagliflozin demonstrated weight loss compared with weight gain in the placebo group

0.5

-1.7

-2

-1.5

-1

-0.5

0

0.5

1


Ch

an

ge

fro

m b

ase

lin

e (

kg

)

*

*P = 0.005 relative to placebo

Diabetes Care. 2015; 38(7):1181-8.

CGM Time in Target, Hyperglycemic,

and Hypoglycemic Ranges T1D

5.8

40.254

7.9

35.756.4

6.7

2568.2

<70 mg/dL

70–180 mg/dL

>180 mg/dL

Blood glucose

CGM

Sotagliflozin

% time in

ranges

Baseline

CGMDays –2 to –6

P=0.003

vs.

placebo

P=0.002

vs.

placebo

Treatment

CGMDays 3–27

8.5

35.

6

55

.

Placebo

% time in

ranges

Diabetes Care. 2015; 38(7):1181-8.

Phase 3 Program in T1DM Summary

inTandem program has the largest efficacy and safety database of an oral anti-diabetic agent for T1DM

Sotagliflozin significantly:

◦ Reduced A1C

◦ Reduced body weight

◦ Reduced blood pressure

◦ Reduced bolus insulin (leading to less hypoglycemia)

◦ Glucose variability (more time in range)

◦ Reduced severe hypoglycemia in the setting of optimized insulin setting

Benefit/risk profile favorable

◦ Additional A1C efficacy on top of insulin (consistent with SGLT 2 inhibition)

◦ Efficacy beyond A1C

◦ No increase in severe hypoglycemia, lower PPG, lower incidence of documented hypoglycemia (consistent with SGLT1 inhibition)

◦ DKA is manageable with appropriate care instructions

Type 2 Diabetes Trends Among

Adults in the U.S. 1990

Mokdad et al., Diabetes Care 2000;23:1278-83.

No Data Less than 4% 4% - 6% Above 6%

www.diabetes.org

Above 10%

Diabetes Trends Among Adults in the U.S.

2017: Over 258 billion dollars a year!

No Data Less than 4% 4% - 6% Above 6%

You Can Get Type 1 and Type 2

Diabetes at Any Age!

Barbara diagnosed

with Type 1 at age 64

Jose diagnosed

with Type 2 at age 5

LADA

Risk of Developing Type 1 And T2D

General Population 0.3% 8-11%

If you have a sibling with T1D

4% ~30%

If your mother has T1D 2 – 3% ~30%

If your father has T1D 6 – 8% ~30%

If you have an identical twin with T1D

~50% 100%72

73

74

75

76

77

78

4.0

4.5

5.0

5.5

6.0

6.5

7.0

7.5

1990 1992 1994 1996 1998 2000

The genes

for type 2

diabetes and

obesity are

linked

together

The Prevalence

of Type 2 Diabetes and Obesity

Pre

vale

nce i

n P

op

ula

tio

n (

%)

Diabetes

Mean body weight

Bo

dy W

eig

ht

kg

Years

1990’s 2017P

ou

nd

s

Central or Abdominal Obesity

of Type 2 Diabetes MRI of the Belly

White is abdominal fat

Diabetes in America.. NIH No. 95-1468. 1995:233-257.

Causes of Mortality in Patients With

Diabetes 20 years Ago:

The same Trend Exists in 2017

STROKE

Other

Pneumonia/

InfluenzaMalignant

Neoplasms

“Diabetes

complications”

10%

13%

13%

4% 5%

55%

Heart Disease

http://professional.diabetes.org/?loc=bb-dorg

Most Common Causes of Death in People With

Type 2 Diabetes: It is not eye, kidney or nerve

disease!

Geiss LS, et al. In: Diabetes in America, 2nd ed. 1995. Bethesda, MD: National Institutes

of Health; 1995:Chapter 11.

0

10

20

30

40

50

% of

Deaths

Ischemic

Heart

Disease

Other

Heart

Disease

Diabetes

related

Cancer Stroke Infection Other

Almost 80% do to any type

of heart disease and stroke

http://professional.diabetes.org/?loc=bb-dorg

Relatively New Class of Injectable

Medications for Type 2 Diabetes

GLP-1 RA Agonists

Improved control (A1c)

WEIGHT LOSS

Low risk of low blood glucose

LillyAstraZeneca NovoNordisk

Trulicity

Sanofi

Fixed Combinations Of Basal Insulin and GLP1-RA

Xultophy and Soliqua

Lancet Diabetes Endocrinol. 2014 Nov;2(11):856-8, 2017 PDR PIs

J

Two excellent diabetes medication in one pen!“Basal insulins that are super charged”

57 years of age BMI 32, drug naïve or metformin

DOD 6.3 years

A1c Oral Semaglutide (-0.7 to -1.9%) Dose ranging

A1c Injectable semaglutide -1.9%

A1cOral placebo -0.3%

Weight loss oral smeaglutide -6.9kg (highest dose)

Weight loss injectable semaglutide -6.4%

Mild to moderate GI side effects in both groups

ITCA 650—Medical Device To

Deliver Type 2 medication

Previously-approved GLP-1

therapeutic with demonstrated:

−Glycemic control

−Weight loss

−Safety

MEDICINE: EXENATIDE

Previously-approved delivery system

Small micropump

−Maintains stability at temps ≈37⁰C

−Maintains stability for > 12 months

TECHNOLOGY

Not yet approved by the FDA

Study SAVOR EXAMINE TECOS CAROLINA CARMELINA

DPP4-i saxagliptin

alogliptin sitagliptin linagliptin linagliptin

Comparator placebo placebo plcebo sulfonylurea placebo

N 16,500 5,400 14,000 6,000 8,300

Results 2013 2013 June 2015

2017 2017

✓ ✓ ✓

Large Non-Insulin CVOTs in T2DM

DPP-4 Inhibitors

Study LEADER ELIXA SUSTAIN 6

EXSCEL REWIND

GLP1-RA liraglutide lixisenatide semaglutide exenatide LR dulaglutide

Comparator placebo placebo placebo placebo placebo

N 16,500 14,000 6,000 5,400 8,300

Results 2016 2015 2016 2018 2019

✓ ✓✓


GLP-1 Receptor Agonists

Courtesy of Silvio Inzucchi MD, Yale University

✓

Study EMPA-REG CANVAS DECLARE NCT01986881

SGLT-2-i empaglifozin canagliflozin dapagliflozin ertugliflozin

Comparator placebo placebo placebo placebo

N 7300 4300 22,200 3900

Results Sept 2015 2017 2019 2020


SGLT-2 Inhibitors

Courtesy of Silvio Inzucchi MD, Yale University

✓ ✓

Investigatte Before Vilifying A Medication

(relative risk vs absolute risk)

(imbalance that is statistically significant)

Avandia (rosiglitazone): CAD Actos (pioglitazone): bladder cancer Insulin glargine (Lantus): breast cancer DPP-4 inhibitors: pancreatic cancer Onglyza (saxagliptin): hosp. for CHF Invokana (canagliflozin): amputation Ozempic (semaglutide) retinopathy/DME

Elvis

Abbott FreeStyle Libre: Now approved in the US

Waterproof

Lasts 10 days

12 hour warm up

Swipe to get a number

No calibration

Low Cost

swipe

Future Developments

Develop:

• A simple

• Easy to apply

• Low cost

• Disposable sensor

• Integrated into a

monitor or smart phone

Will give you a

glucose reading

every 5 minutes!

Natural History of Type 2 Diabetes Is Characterized by

Progressive Loss of Beta Cell Function

Macrovascular complications

Microvascular complications

Insulin resistance

Insulin secretion

Postprandial glucose

Fasting glucose

Progression of Dysglycemia

Prediabetes and Early Type

2 Diabetes: Generally

Asymptomatic

Diagnosis of Type 2

Diabetes Typically Delayed

Years to Decades

Progression to Type 2 Diabetes

Can be Prevented or Delayed

Adapted from Ramlo-Halsted BA, Edelman SV. Prim Care. 1999;26:771-789

Prediabetes Type 2 Diabetes

Completed diabetes prevention trials

Edelman, S. Diagnosis and Management of Type 2 Diabetes 10th Edition, Chapter 16.

Clinical study Treatment (3-4 years)Relative riskreduction

Finnish Diabetes Prevention Study Diet & exercise vs. control 58%

Diabetes Prevention ProgramDiet & exercise vs.placeboMetformin vs placebo

58%31%

STOP-NIDDM Acarbose vs. placebo 25%

Tripod Troglitazone in GDM 56%

XENDOS Orlistat vs. placebo 45%

DREAM Rosiglitazone vs. placebo 62%

ACT NOW Pioglitazone vs. placebo 72%

ORIGINInsulin glargine vs. placebo

28%

Developments In The Past

Decade For Type 2 Diabetes

DPP4 inhibitors (4 in the class)

SGLT2 Inhibitors (3 in the class)

GLP1-RA (5 in the class)

Several positive CVOT trials

Newer basal insulins

Fixed combinations of GLP1-RA & basal insulins

Insulin pumps for type 2 (Vgo and the T-Flex)

Inhaled insulin

Software programs and multiple apps

% o

f P

ati

en

tsa

Ach

ievin

g H

bA

1c <

7%

2003-20061

N=999

0

2007-20101,2

N=1444

2011-20142

N=2677

50

56.8%52.2% 50.9%

10

20

30

40

60

70

90

100

80

NHANES, National Health and Nutrition Examination Survey.aPatients with either Type 1 or Type 2 diabetes.

1. Ali MK et al. N Engl J Med. 2013;368:1613-1624. 2. Carls GS et al. 76th ADA Scientific Sessions. June 10–14, 2016. Poster 1515-P.

NHANES Data

ONLY ABOUT HALF OF PATIENTS ACHIEVE

HbA1c <7% WITH VIRTUALLY NO CHANGE

OVER THE LAST DECADE

NNO CHANGE IN THE LAST DECADE

HEDIS data from >1000 health plans covering >171 million lives (2014)

% o

f P

ati

en

ts A

ch

ievin

g H

bA

1c <

7%

2007 2008 2009 2010 2011 2012 2013 2014 2007 2008 2009 2010 2011 2012 2013 2014

HMO POPULATION MEDICAID POPULATION

ONLY ABOUT 40% OF PATIENTSa

ARE AT HbA1c <7%

ONLY ABOUT 30% OF PATIENTSa

ARE AT HbA1c <7%

0

50

10

20

30

40

60

70

80

90

100

% o

f P

ati

en

ts A

ch

ievin

g H

bA

1c <

7%

0

50

10

20

30

40

60

70

80

90

100

National Committee for Quality Assurance. http://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality.aspx.

HEDIS, Healthcare Effectiveness Data and Information Set.aPatients with either Type 1 or Type 2 diabetes.

COMMERCIAL HMO AND MEDICAID

POPULATION RESULTS ARE EVEN WORSE

NO CHANGE IN 10 YEARS NO CHANGE IN 10 YEARS

HEDIS data from >1000 health plans covering >171 million lives in 2014

2005 2014

29.7% 31.1%OF ALL

PATIENTS

WITH

DIABETES*

OF ALL

PATIENTS

WITH

DIABETES*

% OF DIABETIC

PATIENTS WITH

VERY POOR GLYCEMIC

CONTROL

(HbA1c >9%)

IN THE US

National Committee for Quality Assurance. http://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality.aspx.

*In a commercial HMO population that includes either Type 1 or Type 2 diabetes.

RATES OF VERY POOR GLYCEMIC CONTROL IN

DIABETES HAVE ALSO NOT IMPROVED

$110

$119

$130

$140

$151

$164

$180

$202

$224

$249

$274

$301 $331 $363

$0

$50

$100

$150

$200

$250

$300

$350

$400

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

MEDICAL COSTS OF T2D ARE

INCREASING IN THE US

* Includes medical costs of type 2 diabetes and related complications.

Total US Medical Costs for Diabetes From 2007 to

2020 (in billion US dollars)*

>$1000 cost burden

for every person in

US

Reference: UnitedHealth Group, The United States of Diabetes: Challenges and opportunities in the decade ahead. Working paper 5. November 2010.

DIABETES IS NOT A

RARE DISEASE AND

IT IS NOT AN

INEXPENSIVE

DISEASE

$

Steven V. Edelman, MDClinical Professor of Medicine

University of California, San Diego

Director, Taking Control of Your Diabetes

(TCOYD)

Type 2 Diabetes: Why Do

Clinical Trial Results

Disappear In Real World

Practice?

William Polonsky PhDPresident,g Behaviorall Diabetes Institute (BDI))

Clinical Professor of Medicine

University of California, San Diego

Diabetes Care (accepted for publication)

25%

REAL-WORLD RESULTS

PREDICTED UNDER TYPICAL

TRIAL CONDITIONSa

EXPLAINING

THE GAP

REAL

WORLDb

-1.04%

75%

-0.52%

GAP ADHERENCEc

Carls GS et al. 76th ADA Scientific Sessions. June 10–14, 2016. New Orleans, LA. Poster 117-LB.

BASELINE

CHARACTERISTICS,

ADDITIONAL DRUG

THERAPY

RCT, randomized clinical trial.aLinear regression model fitted to estimate the change in HbA1c 1 year after initiating GLP-1 RA or DPP-4i based on baseline and treatment characteristics. bOptum/Humedica SmartFile database (2007-2014) was used (GLP-1 RA 221 patients; DPP-4i 652 patients). Change in HbA1c measured from drug initiation to 365±90 days later. cMedical adherence classified as poorly adherent if percentage of days covered (PDC) <80%.

{

0

–1.2

–0.4

–0.8

–0.2

Ch

an

ge i

n H

bA

1c (

%)

–1.0

–0.6

–1.4

–1.6

POOR ADHERENCE IS THE KEY

CONTRIBUTOR TO THE EFFICACY GAP: GLP-1

RAs

Video of type 2 live longer

Get Type 2 Diabetes..And Live Longer Because Of It!

THANK

YOU!

[email protected] V. Edelman, MD

Professor of Medicine

University of California San Diego School of Medicine

Veterans Affairs Medical Center

Founder and Director, Taking Control Of Your Diabetes, a 501(c)3

Not-for-Profit Organization

intensive insulin management and basal/bolus therapy

Documents