1. Glycemia Treatment Strategies Used In ACCORD
Presented at the American Diabetes Association
68th Scientific Sessions on June 10, 2008.

2. OUTLINE Glycemia Levels Achieved in the Intensive and Standard Arms
How Targets Were Achieved
Changes in Body Weight
Severe Hypoglycemia

3. Glycemia Levels Achieved

4. A1C Distribution
Standard Rx Goal
Intensive Rx Goal
Dec

5. A1C Distribution: 12 Mo.
Standard Rx Goal
Intensive Rx Goal
Dec

6. A1C Distribution: 24 Mo.
Intensive Rx Goal
Standard Rx Goal
Dec

7. A1C Distribution: 36 Mo.
Intensive Rx Goal
Standard Rx Goal
Dec

8. A1C Distribution: 48 Mo. Standard Rx Goal Intensive Rx Goal
Dec
December 2007

9. Median A1C and Interquartile Ranges
The mean difference during the trial was 1.1%

10. How Targets Were Achieved

11. Achieving Glycemic Goals
Intensive Group
Standard Group
Visits (1st 4 months)
Monthly
Monthly – Q 4 mo*
Visits (after 4 months)
Q 2 mo
Q 2-4 mo*
Phone Contact
Research staff initiated (>1 inter-visit)
Participant initiated
Supplemental Contact
Severe hypoglycemia/ A1C in action required range
Severe hypoglycemia/ hyperglycemia A1C in action required range
POC A1C
Mandatory
Optional
Routine use of postprandial SMBG values to guide therapy
Yes No
* depending on the blood pressure group assignment

12. Achieving Glycemic Goals
Intensive Group
Standard Group
SMBG Frequency
3-8/day (prn 3 am test)
< 3/day
Self Titration
Frequently used
Less frequently used
Initial Minimum Rx
Diet/lifestyle AND 2 oral agents
Diet/lifestyle
Insulin Use
Encouraged, and multiple injections
Generally < 2 injections/day

13. ACCORD Glycemia Formulary
Metformin
Rosiglitazone
Glimepiride
Repaglinide
Acarbose
Glargine Insulin
Aspart Insulin
70/30, N, R Insulin
Exenatide

14. Medications Ever Used During the Trial
Intensive
(N = 5128)
Standard
(N = 5123)
Any Insulin (%)* 77 55
Bolus Insulin (%) 35
Metformin (%) 95 87
Secretagogue (%) 74
Thiozolidinedione% 92 58
Rosiglitazone (%) 91
Acarbose (%) 23 5
Exenatide/Sitagliptin (%) 18
Exenatide (%) 12 4
* % of Participants

15. Usage of Insulin at Last Visit
Intensive
(N=5128)
Standard
(N=5123)
(units/kg)
(% of participants)
Total Insulin
0.69
66%
0.65
47%
Basal Insulin
0.48
64%
0.45
41%
Bolus Insulin
0.33
40%
0.35
20%

16. Design of Intensive Glycemia Intervention
Group
A1C Targets
Intensification Thresholds
A1C
> 50% of SMBG Results/4 Days
Intensive
< 6%
> 5.9%
Fasting > 100 (5.6) OR
2 Hr PP > 140 (7.8)
Even if the A1C is <6.0
Rx was reduced in the presence of
significant hypoglycemia.

17. Design of Standard Glycemia Intervention
Group
A1C Targets
Action Required
Thresholds
A1C
Standard
7-7.9%
>8.0%
6.5%-6.9% X 2 OR
< 6.5%
INCREASE RX
DECREASE Rx if**:
Any Fasting < 90 (5.0)
Symptomatic Hypoglycemia
On Insulin or Secretagogue
**Decrease only insulin or insulin secretagogues.

18. Changes in Body Weight

19. Changes in Body Weight Since Baseline
Decrease
Increase

20. Severe Hypoglycemia

21. ACCORD Definition of a Severe Hypoglycemic Episode
Hypoglycemia requiring medical or paramedical attention, AND
Documented blood glucose < 50 mg/dl (2.8 mmol/L), or
Prompt recovery with administration of oral CHO, IV glucose, or subcutaneous glucagon
Each participant’s ‘Glucose Diary’ was reviewed at each clinic visit
to identify the occurrence of one of these hypoglycemic events

22. Severe Hypoglycemia Monitoring & Management
Severe hypoglycemia events monitored and reported by the clinics
Systematic monitoring, review, and feedback used
Monitors within and external to ACCORD
Feedback on management and prevention provided; A1C goal relaxed, as indicated
Multiple events required detailed review and preventative intervention

23. Number of Participants with Severe Hypoglycemia
Intensive
N (%)
Standard P
Requiring Any Assistance
830 (16.2)
261 (5.1)
<0.001
Requiring Medical Assistance
538 (10.5)
179 (3.5)

24. Number of Participants With One or More Severe Hypoglycemia Events
Requiring Medical Assistance (n and %)
Intensive Group
Standard Group
# Events ** n % 1
400
7.8
130
2.5 2 82
1.6 34
0.7
3 to 5 43
0.8 10
0.2
>5 6
0.1
**Cumulative number of events

25. Incidence of Severe Hypoglycemia per Year (1st event)
% of Participants
Year Post-randomization

26. Conclusion Different Glycemia Treatment Strategies Were Used
Compared with the standard group, the intensive group had:
Lower A1C goal (< 6% vs %)
More visits (q 1-2 mo + at least 1 interim call)
Point of care A1C
Greater use of multiple medications
Greater use of insulin

27. Conclusion Different Glycemia Treatment Strategies Were Used
Implementation of the Intensive Glycemia Strategy versus the Standard Glycemia Strategy was associated with:
More weight gain and in larger number of participants
More frequent episodes of severe hypoglycemia (either single and multiple) in a larger number of participants
Higher rate of mortality