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Effective Use of Insulin in Diabetes: Update for 2007

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Title: Effective Use of Insulin in Diabetes: Update for 2007


1
Effective Use of Insulin in Diabetes Update for
2007
  • Thomas M. Flood, MD
  • Director
  • Georgia Center for Diabetes
  • Atlanta, Georgia

2
Key Question
  • How comfortable are you with initiating insulin
    therapy in your patient population?
  • Completely comfortable
  • Somewhat comfortable
  • Slightly comfortable
  • Not comfortable at all
  • Use your keypad to vote now!

3
Faculty Disclosure
  • Dr Flood has no relevant financial relationships
    with any commercial interests to disclose.

4
Learning Objectives
  • State current management goals for diabetes
  • Identify barriers to optimal use of insulin, and
    how to overcome them
  • Discuss the roles of short-, intermediate-, and
    long-acting insulins in the management of
    diabetes

5
A1C Targets Suggested by Different Organizations

Optimal target A1C lt6 (normal range)
Organization A1C Target ()
AACE lt6.5
EASD lt6.5
ADA lt7 (general) lt6 (individual patient)
As close to normal (lt6) without significant
hypoglycemia. AACE American Association of
Clinical Endocrinologists ADA American
Diabetes Association EASD European Association
for the Study of Diabetes.
6
Key Question
  • What percentage of patients with diabetes
  • achieve the AACE goal of A1C lt6.5?
  • 25
  • 35
  • 55
  • 75
  • Use your keypad to vote now!

7
State of Diabetes in America Blood Sugar
Control Across the United States as Measured by
A1C
National average 67 above goal (A1C ?6.5)
WA 68.4
ME 27.2
MT 55.2
ND 29.7
MN 59.3
VT 26.7 NH 20.4 MA 29.5 CT 28.4 RI
29.5 NJ 67.3 DE 66.4 MD 68.1
VT
OR 64.2
NH
ID 63.3
W 24.2I
NY 71.1
SD 24.6
MA
WY 63.0
MI 65.4
CT
RI
IA 58.9
PA 70.9
NE 56.5
NJ
OH 71.7
NV 67.3
IL 72.6
IN 66.4
MD
UT 72.4
DE
CO 67.1
WV 69.5
CA 34.5
VA 67.7
KS 67.0
KY 66.8
MO 66.2
NC 65.7
TN 65.6
OK 65.6
AR 69.6
AZ 67.3
SC 66.3
NM 68.6
MS 72.8
AL 71.3
GA 69.3
LA 71.3
TX 67.7
FL 63.9
N gt157,000
Top 10 Highest
AACE. State of Diabetes in America. May 2005.
Available at http//www.aace.com/public/awareness
/stateofdiabetes/DiabetesAmericaReport.pdf
8
Diabetes Demographics in the United States
Population Aged 20 Years
Physician-Diagnosed Diabetes () Physician-Diagnosed Diabetes () Undiagnosed Diabetes () Undiagnosed Diabetes ()
Physician-Diagnosed Diabetes () Physician-Diagnosed Diabetes () Undiagnosed Diabetes () Undiagnosed Diabetes ()
1998-1994 2001-2004 1998-1994 2001-2004
Male 5.4 7.6 3.5 4.3
Female 5.4 7.1 2.6 1.8
White 5.0 6.2 2.6 2.8
Black 8.6 11.4 4.2 3.1
Mexican 9.7 11.8 4.7 3.3
Total 5.4 7.3 3.0 3.0
Adapted from National Center for Health
Statistics. Health, United States, 2006. With
Chartbook on Trends in the Health of Americans.
Hyattsville, Md 2006.
9
No A1C Threshold in Type 2 Diabetes
Epidemiologic Data From the UKPDS
80
Myocardial infarction
Microvascular end points
60
AACE Goal
Adjusted Incidence per 1000 Person-Years ()
40
20
?
0
5
6
7
8
9
10
11
Updated Mean A1C ()
UKPDS United Kingdom Prospective Diabetes
Study. Stratton IM et al. BMJ. 2000321405-412.
10
Risk Factor Control in Adults With Diabetes
NHANES III (1988-1994)/NHANES 1999-2000
NHANES III, n 1204
NHANES 1999-2000, n 370
48.2
50
44.3
P lt.001
37.0
40
35.8
33.9
29.0
30
Patients ()
20
10
7.3
5.2
0
A1C lt7
BP lt130/80 mm Hg
TC lt200 mg/dL
Good control
Achieved all 3 indicated goals. BP blood
pressure NHANES National Health and Nutrition
Examination Survey TC total cholesterol.
Saydah SH et al. JAMA. 2004291335-342.
11
Stages of Type 2 Diabetes Criteria for
Advancing to Next Stage?
A1C not at target ?7.0
100
Monotherapy
75
Combination oral therapy
ß-Cell Function ( ß)
50
Insulin
25
Type 2 Diabetes Phase I
Type 2 Diabetes Phase II
Phase III
0
-12
-10
-6
-2
2
0
6
10
14
Years From Diagnosis
Based on data of UKPDS 16. UKPDS Group.
Diabetes. 1995441249-1258.
12
Stepwise Management of Type 2 Diabetes
Adapted from Williams G. Lancet. 199434395-100.
13
Key Question
  • What is the approximate amount that A1C
  • can be lowered through use of oral agents?
  • 1
  • 2
  • 3
  • 4
  • Use your keypad to vote now!

14
Oral Antihyperglycemic MonotherapyMaximum
Therapeutic Effect on A1C
Acarbose
Precose PI. West Haven, Conn Bayer 2003
Aronoff S et al. Diabetes Care.
2000231605-1611 Garber AJ et al. Am J Med.
1997102491-497 Goldberg RB et al. Diabetes
Care. 199619849-856 Hanefeld M et al. Diabetes
Care. 200023202-207 Lebovitz HE et al. J Clin
Endocrinol Metab. 200186280-288 Simonson DC et
al. Diabetes Care. 199720597-606 Wolfenbuttel
BH, van Haeften TW. Drugs. 199550263-288.
15
UKPDS Early Initiation of Insulin Therapy
Improves A1C Control
Conventional therapy Insulin therapy Sulfonylurea
insulin therapy
9
8
7
A1C ()
ULN 6.2
6
5
0
4
1
2
3
6
5
0
Years From Randomization
ULN upper limit of A1C nondiabetic
range. Wright A et al. Diabetes Care.
200225330-336.
16
Clinical Inertia Failure to Advance Therapy
When Required
Last A1C Value Before Abandoning Treatment
10
9.6
9.1
Mean A1C at Last Visit ()
9
8.6
8.8
8
ADA Goal
7
Sulfonylurea
Combination
Diet/Exercise
Metformin
2.5 Years
2.9 Years
2.2 Years
2.8 Years
Brown JB et al. Diabetes Care. 2004271535-1540.
17
Key Question
  • What are the barriers for your patients with
  • type 2 diabetes regarding initiation of
  • insulin therapy?
  • Concern that insulin use is forever
  • Fear of injection
  • Equating insulin use with worsening diabetes and
    complications
  • Fear of weight gain
  • Use your keypad to vote now!

18
Patient Barriers to Insulin Use Perception vs
Reality
Perception Reality
Failing oral therapy Failing oral therapy
58 of patients believe using insulin means they have failed OAD therapy OAD failure is due to progressive nature of type 2 diabetes insulin is best agent to control disease
Needle phobia Needle phobia
Fear associated with early experiences Current needles considered painless easy-to-use injection systems are available
Fear of complications Fear of complications
Common association of insulin with diabetic complications Complications are due to uncontrolled, progressive disease insulin actually results in reduction of vascular damage
OAD oral antidiabetic drug. Meese J. Diabetes
Educ. 2006329S-18S Peyrot M et al. Diabet Med.
2005221379-1385.
19
Clinician Barriers to Insulin Use Perception vs
Reality
Perception Reality
Hypoglycemia is prevalent with insulin use Severe hypoglycemia is very uncommon in patients with type 2 diabetes, occurring at 10 the rate in patients with type 1 diabetes
Insulin use increases atherosclerosis Studies indicate no exacerbation of cardiovascular disease
There is weight gain with insulin use Weight gain is modest and can be controlled with diet and exercise
Patients have a negative attitude regarding insulin use Insulin is a positive approach to achieving glycemic control
Douek IF et al. Diabet Med. 200522634-640
Malmberg K et al. J Am Coll Cardiol.
19952657-65 Malmberg K et al. BMJ.
19973141512-1515 Romano G et al. Diabetes.
1997461601-1606 UKPDS Group. Lancet.
1998352837-853.
20
Information and Patient Education Links for
Healthcare Professionals
  • American Association of Diabetes Educators
    (www.diabeteseducator.org)
  • American Association of Clinical Endocrinologists
    (www.aace.com)
  • American Diabetes Association (www.diabetes.org)
  • International Diabetes Federation (www.idf.org)
  • National Diabetes Education Initiative
    (www.ndei.org)
  • National Diabetes Education Program
    (ndep.nih.gov)
  • National Institute of Diabetes and Digestive and
    Kidney Diseases (www2.niddk.nih.gov)

21
Next Steps
  • What do we do for the patient who has failed on
    1 or 2 oral agents?

22
Basal Insulin Therapy
  • Usual first step when beginning insulin therapy
  • Continue OAD and add basal insulin to optimize
    FPG
  • A1C of up to 9.0 often brought to goal by
    addition of basal insulin therapy to OADs
  • Easy and safe patient-directed treatment
    algorithms with small risk of serious
    hypoglycemia
  • ADA and EASD recommended Although 3 OADs can be
    used, initiation and intensification of insulin
    therapy is preferred based on effectiveness and
    expense

FPG fasting plasma glucose. ADA. Diabetes Care.
200629(suppl 1)S4-S42 AACE position statement.
Available at http//www.aace.com/pub/pdf/guideli
nes/OutpatientImplementationPositionStatement.pdf.
Nathan DM et al. Diabetes Care.
2006291963-1972.
23
Rationale for Basal Insulin TherapyInsulin and
Glucose Patterns
Basal insulin
Normal
T2DM
Glucose
Insulin
400
120
100
300
80
µU/mL
mg/dL
200
60
40
100
20
600
1000
1800
1400
200
2200
600
600
1000
1800
1400
200
2200
600
B
L
D
B
L
D
Time
Time
B breakfast D dinner L lunch T2DM type
2 diabetes mellitus. Polonsky KS et al. N Engl J
Med. 19883181231-1239.
24
Options for Initiating Insulin Therapy
  • Basal insulin
  • NPH insulin (at bedtime)
  • Insulin detemir (once or twice daily)
  • Insulin glargine (once daily)
  • Premixed insulin preparations
  • 70/30 NPH insulin/regular insulin
  • 50/50 NPL insulin/insulin lispro
  • 70/30 NPA insulin/insulin aspart
  • 75/25 NPL insulin/insulin lispro

Analog premixes
NPA neutral protamine aspart NPL neutral
protamine lispro.
25
Idealized Profiles of Human Insulinand Basal
Insulin Analogs
NPH
Plasma Insulin Levels
Detemir
Glargine
200
400
600
800
1200
1400
1600
1800
2000
2200
2400
000
1000
Time
Plank J et al. Diabetes Care. 2005281107-1112
Rave K et al. Diabetes Care. 2005281077-1082
Rosenstock J, Goldstein BJ, et al, eds. Textbook
of Type 2 Diabetes. London, UK, and New York, NY
Martin Dunitz 2003131-154.
26
Twice-Daily Split-Mixed Regimens or
Lispro Mix (75/25)Aspart Mix (70/30)
Glucose levelsInsulin levels
Adapted with permission from Leahy J. In Leahy
J, Cefalu W, eds. Insulin Therapy. New York
Marcel Dekker 200287 Nathan DM. N Engl J Med.
20023471342-1349.
27
Open-Label, Twice-Daily Exenatide vs Once-Daily
Insulin Glargine Self-Monitoring Blood Glucose
Profiles (n 549)
Insulin Glargine 10 U/d, titrated to target FPG
lt100 mg/dL
Exenatide 5 µg bid 1st 4 weeks, then 10 µg bid
240
240
220
220
200
200
180
180
Blood Glucose (mg/dL)
160
160
140
140
Baseline (week 0)
120
120
Baseline (week 0)
Endpoint (week 26)
Endpoint (week 26)
100
100
Prelunch
Prelunch
3 AM
Predinner
3 AM
Predinner
Prebreakfast
Prebreakfast
Both medications lowered A1C from 8.2 to 7.1
from baseline Weight change exenatide 2.3 kg,
glargine 1.8 kg Nausea exenatide 57.1,
glargine 8.6
Heine RJ et al. Ann Intern Med. 2005143559-569.
28
Steps in Transition From Basal to Basal-Bolus
Insulin Therapy in T2DM
Above target A1C gt7.0 FPG gt110 mg/dL
A1C lt7.0, FPG lt110 mg/dL
HS at bedtime. Adapted with permission from
Karl DM. Curr Diab Rep. 20044352-357.
29
Case Study
30
Case Study Initiating Insulin Therapy
  • 60-year-old man 10-year history of T2DM and
    hypertension
  • Current T2DM medications metformin 1000 mg bid,
    rosiglitazone 8 mg AM, and glimepiride 8 mg qd
  • Hypertension medications 40 mg lisinopril, 10 mg
    amlodipine, 12.5 mg HCTZ
  • Dyslipidemia medication 10 mg atorvastatin
  • Physical exam weight 245 lb (10-lb increase)
    height 60 BMI 34.2 kg/m2 waist
    circumference 44 in BP 130/80 mm Hg
  • Laboratory TC 167 mg/dL TG 206 mg/dL HDL
    35 mg/dL LDL 90 mg/dL
  • A1C 8.9 plasma glucose in the office 198
    mg/dL
  • Creatinine 1.1 mg/dL, normal LFTs

HCTZ hydrochlorothiazide TG triglycerides
HDL high-density lipoprotein LFTs liver
function tests BMI body mass index.
31
Case Study (contd)
  • Patient agrees to basal insulin therapy, however
  • Expresses feelings of failure at inability to
    control glycemia with OADs
  • Displays anxiety about injections
  • You explain the progressive nature of diabetes
  • Convey that insulin injections are the best way
    to achieve glycemic control
  • Describe injection options (painless needles,
    injector pens, etc)
  • Indicate that you and the patient will be a
    team in getting to the A1C goal

32
Decision Point
  • Which insulin would you use?
  • NPH at bedtime
  • Glargine once daily
  • Twice-daily premixed
  • Detemir at bedtime
  • Use your keypad to vote now!

33
Treat-to-Target Trial Oral Agents Glargine or
NPH at Bedtime
  • Patients (n 756) with inadequate glycemic
    control (A1C gt7.5) taking 1 or 2 oral agents
  • Started with 10 U/d bedtime basal insulin and
    adjusted weekly to target FPG ?100 mg/dL

Mean self-monitored FPG values from preceding 2 days (mg/dL) Increase of insulin dosage (U/d)
180 8
140 180 6
120 140 4
100 120 2
Hermansen K et al. Diabetes Care.
2006291269-1274 Riddle MC et al. Diabetes
Care. 2003263080-3086.
34
Treat-to-Target Trial Oral Agents Glargine or
NPH at Bedtime (n756) Efficacy Results
In both groups, FPG decreased from 194 or 198
mg/dL to 117 or 130 mg/dL, respectively, by study
end, and A1C decreased from 8.6 to 6.9 by 18
weeks.
Riddle MC et al. Diabetes Care. 2003263080-3086.
35
Treat-to-Target Trial Timing and Frequency of
Hypoglycemia
Hypoglycemia by Time of Day
Basal insulin
Insulin glargine
350


NPH insulin
300

250

Hypoglycemia Episodes (PG ?72 mg/dL)
200



150
100
50
B L D
0
2000
2200
2400
200
400
600
800
1000
1200
1400
1600
1800
2000
Time
P lt.05 (between treatment).
Riddle MC et al. Diabetes Care. 2003263080-3086.
36
Detemir vs NPH Insulin in T2DM (n 476)
Detemir NPH
400 350 300 250 200 150 100 50 0
A1C ()
10.0 9.0 8.0 7.0 6.0
Detemir NPH
Hypoglycemia Events
2
0
4
8
12
16
20
24
-2
0
4
8
12
16
20
24
Study Week
Study Week
All reported events, including symptoms only.
Hermansen K et al. Diabetes Care.
2006291269-1274.
37
Case Study (contd)
  • 10 U glargine is added to OADs
  • Patient is sent home with the 2, 4, 6, 8
    algorithm with a target FPG goal of 100 to 110
    mg/dL.1 Similar algorithm can be used with
    detemir2
  • FPG (mg/dL) ? Insulin Dose
    (U/d)
  • 120-140 2
  • 140-160 4
  • 160-180 6
  • gt180 8

Alternative strategy increase basal insulin dose
by 2 units every 3 days until FPG ?100 mg/dL3
Certain populations (children, pregnant women,
and the elderly) require special considerations.
  1. Riddle MC et al. Diabetes Care.
    2003263080-3086.
  2. Hermansen K et al. Diabetes Care.
    2006291259-1271.
  3. Davies M et al. Diabetes. 200453(suppl 2)1980.

38
Case Study (contd)
  • Patient is seen 1 month later
  • FPG still above 200 mg/dL, using up to 30 U
    daily
  • Patient is frustrated and feels the insulin does
    not work

39
Decision Point
  • What do you do now?
  • Keep increasing the insulin dose
  • Go to twice-daily premixed
  • Switch to exenatide
  • Send patient for gastric bypass consult
  • Use your keypad to vote now!

40
Treat-to-Target Trial
50
45
Units
Total Daily Dose (U)
42
37
40
33
28
30
21
20
10
10
0
21
0
1
2
3
4
5
6
7
8
10
12
15
18
N 756. Riddle MC et al. Diabetes Care.
2003263080-3086.
Weeks in Study
41
Case Study (contd)
  • Patient is taking 75 U with FPG controlled (lt100
    mg/dL to rarely gt110 mg/dL) since last visit 4
    months ago
  • Patients last A1C 6.9, monitoring occasional
    postprandial blood sugars
  • Patient finds insulin injections painless and
    after speaking with you, feels that he is now a
    partner in his therapy program

42
Case Study (contd)
  • Over the next 3 years, patient seen for routine
    follow-up every 3 to 4 months
  • Remains medically stable, with A1C values 6.5
    to 7.2
  • 3.25 years after adding basal insulin glargine,
    A1C has increased to 8.2, however, FPG checks
    remain lt120 mg/dL

43
Decision Point
  • What do you do now?
  • Increase glargine
  • Switch to twice-daily premixed
  • Switch to 4-shot basal-bolus program
  • Increase monitoring to AC and HS, and have
    patient report after 2 weeks
  • Use your keypad to vote now!

AC before meals HS at bedtime.
44
Case Study (contd)
  • Because the patients FPGs are good and
    post-prandial glucose levels are high, the
    decision is made to switch to twice-daily
    premixed insulin
  • The patient is encouraged to increase daily
    monitoring to adjust insulin dose

45
At Lower A1C Levels, PPG Contributes More to
Overall A1C Than FPG
Contribution ()
1
2
3
4
5
A1C Quintile
PPG postprandial glucose. Reprinted with
permission from Monnier L et al. Diabetes Care.
200326881-885.
46
Prandial Excursions Are Evident, Especially
Around a Single Key Meal Insulin Glargine vs
Premixed (n 209)
Premixed
350 300 250 200 150 100 50
Glargine
Baseline
Plasma Glucose (mg/dL)





Week 28
BB
L90
D90
B90
BL
BD
Bed
3 AM
Time of Day
Total units 51.3 26.7 with glargine plus OADs
vs 78.5 39.5 with premixed insulin (BIAsp
70/30) Denotes statistically significant
difference between treatment groups at specific
times. Premixed BIAsp 70/30.
Raskin P et al. Diabetes Care. 200528260-265.
47
Case Study (contd)
Daily Blood Glucose Diary
March 24
Week Ending
Breakfast Breakfast Lunch Lunch Dinner Dinner MS MS Middle of Night
Dose Blood Sugar Dose Blood Sugar Dose Blood Sugar Dose Blood Sugar Middle of Night
Monday 147 110 153 185 57
Tuesday 138 112 170 164 48
Wednesday 140 90 155 205 ?
Thursday 166 105 134 213 60
Friday
Saturday
Sunday
48
Twice-Daily Split-Mixed Regimens or
Lispro Mix (75/25)Aspart Mix
(70/30)
Glucose levelsInsulin levels
Adapted with permission from Leahy J. In Leahy
J, Cefalu W, eds. Insulin Therapy. New York
Marcel Dekker 200287 Nathan DM. N Engl J Med.
20023471342-1349.
49
Idealized Profiles Rapid-Acting Insulin Analogs
Regular insulin
Plasma Insulin Levels
200
400
600
800
1200
1400
1600
1800
2000
2200
2400
000
1000
Time
Inhaled dry human insulin (Exubera) powder
Rosenstock J, Goldstein BJ, et al, eds. Textbook
of Type 2 Diabetes. London, UK, and New York, NY
Martin Dunitz 2003131-154 Plank J et al.
Diabetes Care. 2005 281107-1112 Rave K et al.
Diabetes Care. 2005281077-1082.
50
Case Study (contd)
  • Decision is made to switch to basal-prandial
    therapy to reduce hypoglycemia and postprandial
    highs
  • 60 of patients total daily insulin dose is
    given as basal insulin 54 U glargine qhs
    titrated to FPG 100-110 mg/dL
  • Before the main meal, a rapid-acting analog is
    added glulisine, initiated at 5 units,
    up-titrated using a treat-to-target algorithm
  • Patient continues to self-monitor glucose

51
Meal Insulin Rapid-Acting Analogs (Lispro,
Aspart, Glulisine) vs Regular
10
8
6
Insulin Activity
4
2
0
1
2
3
4
5
6
7
8
9
10
11
12
0
Hours
RHI regular human insulin. Adapted with
permission from Howey DC et al. Diabetes.
199443396-402.
52
Advantages of Rapid-Acting Analogs
  • Short duration of actionfewer between-meal
    hypos than regular insulin
  • Flexible mealtime dosing
  • More consistent kinetics
  • Day to day
  • Across anatomical sites
  • With large doses
  • Slightly faster onset of glulisine action
    (compared to lispro) in obese and morbidly obese
    subjects (independent of BMI)

Adapted from Hirsch IB. N Engl J Med.
2005352174-183. Becker RHA et al. Exp Clin
Endocrinol Diabetes. 2005113435-443. Heise T
et al. Diabetes. 200554(suppl 1)A145.
53
Decision Point
  • The best time to use a rapid-acting insulin
  • analog is
  • Before a meal
  • After a meal
  • Either works well
  • Use your keypad to vote now!

54
Pre- and Postmeal Efficacy of Insulin Glulisine
vs Regular Human Insulin
Significant reduction in A1C with pre- and
postmeal glulisine
P lt.05
P lt.05
P lt.05
Baseline
Endpoint
Significant A1C reduction with premeal glulisine
compared to premeal human insulin
Garg SK et al. Endocr Pract. 20051111-17 Garg
SK et al. Poster presented at ADA 64th Annual
Scientific Sessions, June 4-8, 2004, Diabetes.
7529P.
55
Case Study (contd)
  • At 6-month follow-up patient is doing well with
    70 U glargine and 10 U to 17 U glulisine at
    supper
  • Actual dose adjusted by
  • Meal carbohydrate content
  • Activity
  • Insulin supplement of additional 1 U for every
    25 mg/dL above 130 mg/dL (prandial glucose)
  • A1C 6.3
  • He feels well, has infrequent hypos, and is
    pleased with his blood glucose control

56
Q A
57
PCE Takeaways
58
PCE Takeaways Basal-Prandial Insulin Replacement
  1. An effective insulin treatment strategy provides
    both basal and postprandial insulin coverage
  2. Initially, prandial insulin may be needed only at
    the largest meal of the day, with coverage at
    other meals added based on prandial glucose
    levels
  3. Rapid-acting insulin analogs closely match normal
    mealtime insulin patterns

59
Key Question
  • How much more comfortable do you now feel you
    will be initiating insulin therapy in your
    patient population?
  • Much more comfortable
  • Somewhat comfortable
  • Slightly comfortable
  • Not comfortable at all
  • Use your keypad to vote now!
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