KEY CLINICAL DIFFERENCES OF NOVEL INSULIN PRODUCTS: … · The effect of three CME activities on...

Amy T. Larkin, PharmD, Colleen S. Healy, MA; Anne Le, PharmD Medscape Education, LLC, New York, NY, USA

KEY CLINICAL DIFFERENCES OF NOVEL INSULIN PRODUCTS: EFFECT OF ONLINE CME AND NEED FOR FURTHER EDUCATION

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INTRODUCTION

Novel basal insulin analogues are efficacious, produce stable pharmacokinetic/pharmacodynamic profiles at a steady state, and are associated with a lower incidence of hypoglycemia. [ADA 2016; Owens 2014] We sought to determine if an online continuing medical education (CME) curriculum could improve the clinical knowledge and competence of primary care physicians (PCPs) and diabetologists/endocrinologists (diabs/endos) regarding key clinical differences between novel and traditional insulin products.

Source of Support

This project was developed with support of an independent educational grant from Novo Nordisk.

Notes

For more information, contact Amy Larkin, PharmD, Director of Clinical Strategy, Medscape, LLC, at [email protected].

The effect of three CME activities on differences of novel insulin formulations compared with traditional options was analyzed to determine efficacy of online education presented in the form of video-based discussions between 2 or 3 leading experts in the area of insulin and diabetes management. In addition to being available via a desktop or laptop, the activities were available on the Medscape Mobile application, ensuring on-demand access by the many clinicians who rely on mobile devices for education.

References

1. American Diabetes Association (ADA). Approaches to glycemic treatment. Dia Care. 2016;39(Suppl 1):S52-S59.

2. Owens DR, Matfin G, Monnier L. Basal insulin analogues in the management of diabetes mellitus: what progress have we made? Diabetes Metab Res Rev. 2014;30(2):104-19.

PCPs demonstrated a lower baseline knowledge level compared to diabs/endos as shown by the following baseline data:

■ 49% of PCPs (n=149) compared to 85% of diabs/endos (n=75) recognized the mechanism of action of an ultra-long acting basal insulin (Figure 1)

■ 68% of PCPs (n=149) compared to 83% of diabs/endos (n=75) identified appropriate titration schedules (Figure 2)

50%

0%

20%

40%

60%

80%

100%

Question #1 Question #2 Question #3 Question #4

% Correct Pre % Correct Post Relative % Change

75% 45% 107%

Nephrologists (n = 113)

87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%

Primary Care Physicians (n = 214)

35%

50%

53%

FIGURE 1.

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

FIGURE 2.FIGURE 7.

ALL ACTIVITIES LAUNCHED ONLINE OCTOBER 30, 2015

Statistical Analysis

We assessed the effects of education for each activity using a 4-question repeated-pairs, pre-/post-assessment study design (Linked Learning Assessment, or LLA). McNemar’s chi-squared test measured if the mean post-assessment score differed from the mean pre-assessment score. P values are shown as a measure of significance; P values <.05 are statistically significant.

Significant overall improvements (P < .05) were seen in all activities. Specific areas of improvement after participation in educational initiatives include:

■ 13% more PCPs (n=149) correctly identified appropriate titration schedules (Figure 3)

■ 21% more PCPs (n=163) correctly identified clinical effects of a combination glucagon-like peptide-1 (GLP-1) receptor agonist + basal insulin therapy (Figure 4)

■ 11% more PCPs (N=163) correctly understood the need for dose conversion when switching between insulin products (Figure 5)

■ 21% more PCPs (N=163) correctly identified the role of combination therapy in individualizing treatment (Figure 6)

Additional education needed as demonstrated by the following post-assessment knowledge gap:

■ 69% (n=177) of PCPs and 70% of diabs/endos (n=43) incorrectly identified the efficacy of combination GLP-1 receptor agonist and basal insulin therapy (Figure 7)

The mechanism of action of insulin degludec, an ultra-long-acting basal insulin analog, is:

A 43-year-old patient is obese and highly insulin resistant, requiring total daily doses of 300 U/d. Her most recent HbA1c is 9.9%. Insulin glargine U-300 is 3 times more concentrated than glargine U-100 and is an appropriate option for this patient. How often should the glargine U-300 dose be titrated?

0%

20%

40%

60%

80%

100%

Formation of multihexamers on

subcutaneous injection

Production of antibod-ies within the circulation

Creation of variable glucose-lowering profiles during the

dosing interval

Pegylation of insulin degludec

Diab/Endo (n=75) PCPs (n=149)

85%

49%

1%7% 4%

18%

9%

26%

0%

20%

40%

60%

80%

100%

Diab/Endo (n=75) PCPs (n=149)

The dose should be titrated every

3 to 4 days

83%

68%


1 to 2 days

11%19%

The dose should be titrated every day

7%13%

FIGURE 3.

FIGURE 4.

FIGURE 6.

A 43-year-old patient is obese and highly insulin resistant, requiring total daily doses of 300 U/d. Her most recent HbA1c is 9.9%. Insulin glargine U-300 is 3 times more concentrated than glargine U-100 and is an appropriate option for this patient. How often should the glargine U-300 dose be titrated?

Insulin degludec, a long-acting basal insulin analog, was approved by the US FDA on September 25, 2015. An option for intensifying insulin is to add a GLP-1 agonist to basal insulin for prandial control. Which of the following clinical effects can be seen from this combination therapy compared with insulin glargine?

You are seeing a 52-year-old obese man (BMI, 34 kg/m2) with a history of type 2 diabetes for 7 years. He is currently on metformin 1000 mg twice daily. Despite walking daily with his wife and taking his metformin regularly, his HbA1c remains at 8.6%. Which of the following treatment approaches is most likely to achieve a glycemic target (HbA1c) of <7% with the least weight gain?

0%

20%

40%

60%

80%

100%

PCPs Pre-assessment (n=149) PCPs Post-assessment (n=149) P <.05


3 to 4 days

68%

81%


1 to 2 days

19%14%

The dose should be titrated every day

13%5%

P <.05

FIGURE 5. Which of the following statements about insulin glargine U-100 and insulin glargine U-300 is true for the treatment of a patient with type 2 diabetes?

0%

20%

40%

60%

80%

100%

Insulin glargine U-300 is available in a vial

and syringe

No dose conversion is needed when switching

a patient from U-100 to U-300

When switching a patient from

U-100 to U-300, a dose conversion is needed

The daily dose of U-100 and U-300 will be the same

12%7%

26%

37%

47% 50%

15%

6%


P <.05

0%

20%

40%

60%

80%

100%

Additional HbA1c

lowering and less risk of hypoglycemia

compared to basal insulin alone

Additional HbA1c

lowering but with weight gain compared to basal insulin alone

Similar HbA1c lowering and weight loss

Similar HbA1c lowering and less risk of hypoglycemia

compared to basal insulin alone

47%

68%

12%6%

21%

8%

21% 18%


P <.05

0%

20%

40%

60%

80%

100%

DPP-4 inhibitor Basal insulin alone GLP-1 agonist Combination basal insulin and GLP-1 agonist therapy

10%3% 3% 3%

26%

11%

61%

82%


P <.05

Based on recent clinical studies such as DUAL™ V, what would be the average HbA1c reduction over the next 26 weeks if insulin glargine was switched to IDegLira, a coformulation of insulin degludec and liraglutide, while continuing on metformin?

0%

20%

40%

60%

80%

100%

-0.8% -1.0% -1.5% -1.8%

Endo (n=177) PCPs (n=43)

35%28%

12%17%

23% 24%30% 31%

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

50%

0%

20%

40%

60%

80%

100%



75% 45% 107%


87%

61%

88%82%

53%

40%

0%

20%

40%

60%

80%

100%



169% 105% 24% 165%

100%

79%71%

26% 27%

65%

24%

64%


35%

50%

53%

DATA WERE COLLECTED THROUGH DECEMBER 24, 2015, FOR ACTIVITY 1

DATA WERE COLLECTED THROUGH DECEMBER 21, 2015, FOR ACTIVITY 2

DATA WERE COLLECTED THROUGH JANUARY 6, 2016, FOR

ACTIVITY 3.

METHODS

RESULTS

■ This study demonstrates the success of a targeted, clinically relevant educational intervention with multiple online video-based educational components on improving knowledge and competence of PCPs regarding key clinical differences of diabetes of novel insulin products

■ PCPs were found to have lower baseline knowledge an competence compared to diabs/endos, and need more foundational education relevant to all knowledge areas examined

■ Both groups need additional education regarding clinical effectiveness of basal insulin + GLP-1 receptor agonist therapy

CONCLUSIONS

ACTIVITY 2

ACTIVITY 3

ACTIVITY 1

KEY CLINICAL DIFFERENCES OF NOVEL INSULIN PRODUCTS: … · The effect of three CME activities on...

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