Study Medication Adherence and

Outcomes in the TODAY Cohort

Presented for the TODAY Study Group by

Siripoom McKay, MD
Funded by

Disclosure of Presenter
Siripoom McKay, MD
Department of Pediatrics
Baylor College of Medicine
No conflicts to disclose.

TODAY Study Design

10-17 years old in 15 US sites
diagnosed with type 2 diabetes <2 yrs
2-6 month pre-randomization run-in
Master standard diabetes education
80% adherence to bid metformin for 8 of 12 weeks
HbA1c <8.0% on metformin 500-1000 mg bid for 2 months
2 missed visits

Randomized to one of 3 treatment arms (n=699)

Metformin alone (M)
Metformin plus rosiglitazone (M+R)
Metformin plus lifestyle program (M+L)

4 year enrollment period, 2-6 years follow-up

3

Presentation Objectives
To examine relationships between
medication adherence and
Demographic characteristics
Depressive symptoms at randomization
Failure to maintain glucose control
Insulin sensitivity

Medication Adherence
Adherence analyzed as <80% versus 80%
Barriers to adherence and strategies to improve
adherence discussed at each visit
7-day blister packs of 2 pills in a.m. and 2 pills in p.m.
Blinded capsules contained metformin rosiglitazone
Pill counts recorded at each visit
every 2 months in year 1 and quarterly thereafter

Outcomes
Demographic
Depressive symptoms
Score 13 on Child Depression
Inventory (age <16)
Score 14 on Beck Depression
Inventory (age 16-17)
Failure to maintain glycemic control on
randomized treatment (primary outcome)
Insulin sensitivity = 1/Fasting Insulin
6

Percent with Study Medication Adherence

80% over Time by Treatment
100

percent with >=80% adherence

90
80
70
60
50
40
M

30

Treatment group p = NS

M+R

Time p < 0.0001

M+L

20
10
0
2

10

12 15 18 21 24 27 30 33 36
months in study on randomized treatment

39

42

45

48

Demographic and Baseline Characteristics by Overall Adherence

Age (years)
Female

Race-ethnicity
Non-Hispanic Black
Hispanic
Non-Hispanic White
Highest household education
Less than high school
HS, GED, business, technical
College

<80% (44%)

80% (56%)

p-value

14.1 (1.9)

13.9 (2.1)

0.2809

63.4%

64.1%

0.8418

0.1036
36.0%
46.2%
17.8%

33.1%
41.9%
25.0%
0.9894

26.5%
24.7%
48.8%

27.0%
24.5%
48.5%

Annual household income

<$25,000
$25,000-$49,999
$50,000

0.2510
44.5%
33.6%
21.9%

38.6%
34.4%
27.0%

Depressive symptoms

17.7%

12.0%

0.0415

Loss of glycemic control

36.6%

48.8%

0.0018
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Insulin Sensitivity Over Time by

Overall Medication Adherence

p=0.0012

<80% _____
80% _ _ _ _
months in study on randomized treatment
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Summary
In the TODAY cohort of youth with type 2 diabetes:
Race-ethnicity, gender, parental education, and family
income were not associated with adherence.
Depressive symptoms at randomization were
associated with lower levels of study medication
adherence.
Higher treatment failure rates were seen in the more
adherent group.
Higher adherence was associated with better insulin
sensitivity.

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