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Published in: Advances in Therapy 12/2013

Open Access 01-12-2013 | Original Research

The INITIATOR Study: Pilot Data on Real-World Clinical and Economic Outcomes in US Patients with Type 2 Diabetes Initiating Injectable Therapy

Authors: Sarah Thayer, Wenhui Wei, Erin Buysman, Lee Brekke, William Crown, Michael Grabner, Swetha Raparla, Ralph Quimbo, Mark J. Cziraky, Wenli Hu, Robert Cuddihy

Published in: Advances in Therapy | Issue 12/2013

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Abstract

Introduction

Type 2 diabetes mellitus (T2DM) progression often results in treatment intensification with injectable therapy to maintain glycemic control. Using pilot data from the Initiation of New Injectable Treatment Introduced after Anti-diabetic Therapy with Oral-only Regimens study, real-world treatment patterns among T2DM patients initiating injectable therapy with insulin glargine or liraglutide were assessed.

Methods

This was a retrospective analysis of claims from the OptumInsight™ (OI; January 1, 2010 to July 30, 2010) and HealthCore® (HC; January 1, 2010 to June 1, 2010) health insurance databases. Baseline characteristics, health care resource utilization, and costs were compared between adults with T2DM initiating injectable therapy with insulin glargine pen versus liraglutide. Follow-up outcomes, including glycated hemoglobin A1c (A1C), hypoglycemia, health care utilization, and costs, were assessed.

Results

At baseline, almost one in three liraglutide patients (OI, n = 363; HC, n = 521) had A1C <7.0%, while insulin glargine patients (OI, n = 498; HC, n = 1,188) had poorer health status, higher A1C (insulin glargine: 9.8% and 9.1% versus liraglutide: 7.9% and 7.7%, OI and HC, respectively, both P < 0.001), and were less likely to be obese (insulin glargine: 10.8% and 9.2% versus liraglutide: 17.4% and 18.8%, OI and HC, respectively, both P < 0.01). The percentage of patients experiencing a hypoglycemic event was numerically higher for insulin pen use for both cohorts (OI 4.4% versus 3.0%; HC 6.2% versus 2.3%). During follow-up, in the insulin glargine cohort, annualized diabetes-related costs remained unchanged ($8,344 versus $7,749 OI, and $7,094 versus $7,731 HC), despite a significant increase in pharmacy costs, due to non-significant decreases in medical costs, while the liraglutide cohort had a significant increase in annualized diabetes-related costs ($4,510 versus $7,731 OI, and $4,136 versus $7,111 HC; both P < 0.001) due to a non-significant increase in medical costs coupled with a significant increase in pharmacy costs.

Conclusion

These descriptive data identified differences in demographic and baseline clinical characteristics among patients initiating injectable therapies. The different health care utilization and cost patterns warrant further cost-effectiveness analysis.
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Literature
1.
go back to reference Inzucchi SE, Nauck M, Bergenstal RM, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Diabetes Care. 2012;35:1364–79.PubMedCentralPubMedCrossRef Inzucchi SE, Nauck M, Bergenstal RM, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Diabetes Care. 2012;35:1364–79.PubMedCentralPubMedCrossRef
2.
go back to reference Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers: results of the cross-national diabetes attitudes, wishes, and needs (DAWN) study. Diabetes Care. 2005;28:2673–9.PubMedCrossRef Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers: results of the cross-national diabetes attitudes, wishes, and needs (DAWN) study. Diabetes Care. 2005;28:2673–9.PubMedCrossRef
3.
go back to reference Karter AJ, Subramanian U, Saha C, et al. Barriers to insulin initiation: the translating research into action for diabetes insulin starts project. Diabetes Care. 2010;33:733–5.PubMedCentralPubMedCrossRef Karter AJ, Subramanian U, Saha C, et al. Barriers to insulin initiation: the translating research into action for diabetes insulin starts project. Diabetes Care. 2010;33:733–5.PubMedCentralPubMedCrossRef
4.
go back to reference Oliveria SA, Menditto LA, Ulcickas Yood M, Koo YH, Wells KE, McCarthy BD. Barriers to the initiation of, and persistence with, insulin therapy. Curr Med Res Opin. 2007;23:3105–12.PubMedCrossRef Oliveria SA, Menditto LA, Ulcickas Yood M, Koo YH, Wells KE, McCarthy BD. Barriers to the initiation of, and persistence with, insulin therapy. Curr Med Res Opin. 2007;23:3105–12.PubMedCrossRef
5.
go back to reference Anderson BJ, Redondo MJ. What can we learn from patient-reported outcomes of insulin pen devices? J Diabetes Sci Technol. 2011;5:1563–71.PubMedCentralPubMed Anderson BJ, Redondo MJ. What can we learn from patient-reported outcomes of insulin pen devices? J Diabetes Sci Technol. 2011;5:1563–71.PubMedCentralPubMed
6.
go back to reference Peyrot M, Rubin RR. Physician perception and recommendation of insulin pens for patients with type 2 diabetes mellitus. Curr Med Res Opin. 2008;24:2413–22.PubMedCrossRef Peyrot M, Rubin RR. Physician perception and recommendation of insulin pens for patients with type 2 diabetes mellitus. Curr Med Res Opin. 2008;24:2413–22.PubMedCrossRef
7.
go back to reference Asche CV, Shane-McWhorter L, Raparla S. Health economics and compliance of vials/syringes versus pen devices: a review of the evidence. Diabetes Technol Ther. 2010;12:S101–8.PubMed Asche CV, Shane-McWhorter L, Raparla S. Health economics and compliance of vials/syringes versus pen devices: a review of the evidence. Diabetes Technol Ther. 2010;12:S101–8.PubMed
8.
go back to reference Lee W, Balu S, Cobden D, Joshi AV, Pashos CL. Medication adherence and the associated health economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of third party managed care claims data. Clin Ther. 2006;28:1712–23.PubMedCrossRef Lee W, Balu S, Cobden D, Joshi AV, Pashos CL. Medication adherence and the associated health economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of third party managed care claims data. Clin Ther. 2006;28:1712–23.PubMedCrossRef
9.
go back to reference Pawaskar MD, Camacho FT, Anderson RT, Cobden D, Joshi AV, Balkrishnan R. Health care costs and medication adherence associated with initiation of insulin pen therapy in medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis. Clin Ther. 2007;29:1294–305.CrossRef Pawaskar MD, Camacho FT, Anderson RT, Cobden D, Joshi AV, Balkrishnan R. Health care costs and medication adherence associated with initiation of insulin pen therapy in medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis. Clin Ther. 2007;29:1294–305.CrossRef
10.
go back to reference Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met + SU): a randomised controlled trial. Diabetologia. 2009;52:2046–55.PubMedCentralPubMedCrossRef Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met + SU): a randomised controlled trial. Diabetologia. 2009;52:2046–55.PubMedCentralPubMedCrossRef
11.
go back to reference Chang HY, Weiner JP, Richards TM, Bleich SN, Segal JB. Validating the adapted diabetes complications severity index in claims data. Am J Manag Care. 2012;18:721–6.PubMed Chang HY, Weiner JP, Richards TM, Bleich SN, Segal JB. Validating the adapted diabetes complications severity index in claims data. Am J Manag Care. 2012;18:721–6.PubMed
12.
go back to reference Solberg LI, Engebretson KI, Sperl-Hillen JM, Hroscikoski MC, O’Connor PJ. Are claims data accurate enough to identify patients for performance measures or quality improvement? The case of diabetes, heart disease, and depression. Am J Med Qual. 2006;21:238–45.PubMedCrossRef Solberg LI, Engebretson KI, Sperl-Hillen JM, Hroscikoski MC, O’Connor PJ. Are claims data accurate enough to identify patients for performance measures or quality improvement? The case of diabetes, heart disease, and depression. Am J Med Qual. 2006;21:238–45.PubMedCrossRef
13.
go back to reference Chen G, Khan N, Walker R, Quan H. Validating ICD coding algorithms for diabetes mellitus from administrative data. Diabetes Res Clin Pract. 2010;89:189–95.PubMedCrossRef Chen G, Khan N, Walker R, Quan H. Validating ICD coding algorithms for diabetes mellitus from administrative data. Diabetes Res Clin Pract. 2010;89:189–95.PubMedCrossRef
14.
go back to reference Quan H, Sundararajan V, Halfon P, et al. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005;43:1130–9.PubMedCrossRef Quan H, Sundararajan V, Halfon P, et al. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005;43:1130–9.PubMedCrossRef
15.
go back to reference US Department of Labor, Bureau of Labor Statistics. Consumer Price Index. Chained Consumer Price Index for all urban consumers (C-CPI-U) 1999-2008, Medical Care. Series ID: SUUR0000SAM. Washington, DC: U.S. Dept. of Labor, Bureau of Labor Statistics, 2008. http://data.bls.gov/cgi-bin/surveymost?su. Last accessed August 28, 2013. US Department of Labor, Bureau of Labor Statistics. Consumer Price Index. Chained Consumer Price Index for all urban consumers (C-CPI-U) 1999-2008, Medical Care. Series ID: SUUR0000SAM. Washington, DC: U.S. Dept. of Labor, Bureau of Labor Statistics, 2008. http://​data.​bls.​gov/​cgi-bin/​surveymost?​su. Last accessed August 28, 2013.
16.
go back to reference Baser O, Wei W, Baser E, Xie L. Clinical and economic outcomes in patients with type 2 diabetes initiating insulin glargine disposable pen versus exenatide BID. J Med Econ. 2011;14:673–80.PubMedCrossRef Baser O, Wei W, Baser E, Xie L. Clinical and economic outcomes in patients with type 2 diabetes initiating insulin glargine disposable pen versus exenatide BID. J Med Econ. 2011;14:673–80.PubMedCrossRef
17.
go back to reference Xie L, Wei W, Pan C, Du J, Baser O. A real-world study of patients with type 2 diabetes initiating basal insulins via disposable pens. Adv Ther. 2011;28:1000–11.PubMedCrossRef Xie L, Wei W, Pan C, Du J, Baser O. A real-world study of patients with type 2 diabetes initiating basal insulins via disposable pens. Adv Ther. 2011;28:1000–11.PubMedCrossRef
18.
go back to reference Xie L, Zhou S, Wei W, Gill J, Pan C, Baser O. Does pen help? A real-world outcomes study of switching from vial to disposable pen among insulin glargine-treated patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2013;15:230–6.PubMedCrossRef Xie L, Zhou S, Wei W, Gill J, Pan C, Baser O. Does pen help? A real-world outcomes study of switching from vial to disposable pen among insulin glargine-treated patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2013;15:230–6.PubMedCrossRef
19.
go back to reference Davis SN, Wei W, Garg S. Clinical impact of initiating insulin glargine therapy with disposable pen versus vial in patients with type 2 diabetes mellitus in a managed care setting. Endocr Pract. 2011;17:845–52.PubMedCrossRef Davis SN, Wei W, Garg S. Clinical impact of initiating insulin glargine therapy with disposable pen versus vial in patients with type 2 diabetes mellitus in a managed care setting. Endocr Pract. 2011;17:845–52.PubMedCrossRef
20.
go back to reference Zhao Y, Campbell CR, Fonseca V, Shi L. Impact of hypoglycemia associated with antihyperglycemic medications on vascular risks in veterans with type 2 diabetes. Diabetes Care. 2012;35:1126–32.PubMedCentralPubMedCrossRef Zhao Y, Campbell CR, Fonseca V, Shi L. Impact of hypoglycemia associated with antihyperglycemic medications on vascular risks in veterans with type 2 diabetes. Diabetes Care. 2012;35:1126–32.PubMedCentralPubMedCrossRef
21.
go back to reference Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of < 7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012;14:77–82.PubMedCrossRef Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of < 7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012;14:77–82.PubMedCrossRef
22.
go back to reference Astrup A, Carraro R, Finer N, et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes. 2012;36:843–54.CrossRef Astrup A, Carraro R, Finer N, et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes. 2012;36:843–54.CrossRef
Metadata
Title
The INITIATOR Study: Pilot Data on Real-World Clinical and Economic Outcomes in US Patients with Type 2 Diabetes Initiating Injectable Therapy
Authors
Sarah Thayer
Wenhui Wei
Erin Buysman
Lee Brekke
William Crown
Michael Grabner
Swetha Raparla
Ralph Quimbo
Mark J. Cziraky
Wenli Hu
Robert Cuddihy
Publication date
01-12-2013
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 12/2013
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-013-0074-8

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