Glycemic Control With Insulin Glargine Plus Insulin Glulisine Versus Premixed Insulin Analogues in Real-World Practices: A Cost-Effectiveness Study With a Randomized Pragmatic Trial Design

Philip Levin, Quanwu Zhang, James H. Mersey, Francis Y. Lee, Lee A. Bromberger, Madhu Bhushan, Rajat Bhushan

Research output: Contribution to journalArticle

Abstract

Background: Cost can be an important consideration, along with safety and efficacy, in deciding the most appropriate treatment for patients with type 2 diabetes. Both basal-bolus and premixed insulin analogue regimens are widely used in clinical practice; however, limited information is available regarding cost-effectiveness. Objective: The goal of this study was to compare glycemic control, cost-effectiveness, and quality of life effects of insulin glargine plus insulin glulisine (glargine/glulisine) versus premixed insulin analogues in real-world clinical practice. Methods: Adults with type 2 diabetes (glycosylated hemoglobin [HbA 1c] 7.0%) at 3 US endocrinology centers were randomly assigned to receive either glargine/glulisine or premixed insulin analogues and continued treatment following the centers' usual practice. HbA 1c, weight, insulin dose, concomitant oral antidiabetic drug (OAD) usage, and hypoglycemia were evaluated at baseline and 3, 6, and 9 months. Medication costs, including costs for all insulin or OAD regimens, were estimated using published wholesale acquisition costs. Results: A total of 197 patients were randomized to receive glargine/glulisine therapy (n = 106) or premixed analogue therapy (n = 91). Overall, the mean age was 56 years, the mean duration of diabetes was 13 years, with a mean HbA 1c of 9.25% and mean BMI of 35.8 kg/m 2 at baseline. Patients randomized to receive glargine/glulisine had a greater mean HbA 1c reduction from baseline (-2.3%) than patients receiving a premixed analogue regimen (-1.7%). Adjusted mean follow-up HbA 1c was 6.9% versus 7.5%, respectively (difference, -0.59%; P <0.01). The glargine/glulisine group also used a lower mean number of OADs (0.86 vs 1.14; difference, -0.28; P = 0.04) but had a higher weight (240 vs 235 lb; difference, 4.55 lb; P = 0.03) than the premixed analogue group at follow-up. There were no significant differences in daily insulin dose and rates of hypoglycemia. Overall medication costs per 1.0% reduction in HbA 1c were 841 with glargine/glulisine and 1308 with premixed analogues. Conclusions: Overall, treatment with glargine/glulisine provided greater improvement in glycemic control and may represent a more cost-effective treatment option than premixed regimens for patients with type 2 diabetes in real-world clinical practice. However, due to the pragmatic trial design, the study concluded before follow-up assessments were available for all randomized patients.

Original languageEnglish (US)
Pages (from-to)841-850
Number of pages10
JournalClinical Therapeutics
Volume33
Issue number7
DOIs
StatePublished - Jul 2011
Externally publishedYes

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Pragmatic Clinical Trials
Cost-Benefit Analysis
Insulin
Costs and Cost Analysis
Type 2 Diabetes Mellitus
Hypoglycemia
Hypoglycemic Agents
Therapeutics
Weights and Measures
Endocrinology
Glycosylated Hemoglobin A
Insulin Glargine
insulin glulisine
Health Care Costs
Quality of Life
Safety

Keywords

  • Cost-effectiveness
  • Insulin glargine
  • Insulin glulisine
  • Premixed insulin
  • Type 2 diabetes

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Glycemic Control With Insulin Glargine Plus Insulin Glulisine Versus Premixed Insulin Analogues in Real-World Practices : A Cost-Effectiveness Study With a Randomized Pragmatic Trial Design. / Levin, Philip; Zhang, Quanwu; Mersey, James H.; Lee, Francis Y.; Bromberger, Lee A.; Bhushan, Madhu; Bhushan, Rajat.

In: Clinical Therapeutics, Vol. 33, No. 7, 07.2011, p. 841-850.

Research output: Contribution to journalArticle

Levin, Philip ; Zhang, Quanwu ; Mersey, James H. ; Lee, Francis Y. ; Bromberger, Lee A. ; Bhushan, Madhu ; Bhushan, Rajat. / Glycemic Control With Insulin Glargine Plus Insulin Glulisine Versus Premixed Insulin Analogues in Real-World Practices : A Cost-Effectiveness Study With a Randomized Pragmatic Trial Design. In: Clinical Therapeutics. 2011 ; Vol. 33, No. 7. pp. 841-850.
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abstract = "Background: Cost can be an important consideration, along with safety and efficacy, in deciding the most appropriate treatment for patients with type 2 diabetes. Both basal-bolus and premixed insulin analogue regimens are widely used in clinical practice; however, limited information is available regarding cost-effectiveness. Objective: The goal of this study was to compare glycemic control, cost-effectiveness, and quality of life effects of insulin glargine plus insulin glulisine (glargine/glulisine) versus premixed insulin analogues in real-world clinical practice. Methods: Adults with type 2 diabetes (glycosylated hemoglobin [HbA 1c] 7.0{\%}) at 3 US endocrinology centers were randomly assigned to receive either glargine/glulisine or premixed insulin analogues and continued treatment following the centers' usual practice. HbA 1c, weight, insulin dose, concomitant oral antidiabetic drug (OAD) usage, and hypoglycemia were evaluated at baseline and 3, 6, and 9 months. Medication costs, including costs for all insulin or OAD regimens, were estimated using published wholesale acquisition costs. Results: A total of 197 patients were randomized to receive glargine/glulisine therapy (n = 106) or premixed analogue therapy (n = 91). Overall, the mean age was 56 years, the mean duration of diabetes was 13 years, with a mean HbA 1c of 9.25{\%} and mean BMI of 35.8 kg/m 2 at baseline. Patients randomized to receive glargine/glulisine had a greater mean HbA 1c reduction from baseline (-2.3{\%}) than patients receiving a premixed analogue regimen (-1.7{\%}). Adjusted mean follow-up HbA 1c was 6.9{\%} versus 7.5{\%}, respectively (difference, -0.59{\%}; P <0.01). The glargine/glulisine group also used a lower mean number of OADs (0.86 vs 1.14; difference, -0.28; P = 0.04) but had a higher weight (240 vs 235 lb; difference, 4.55 lb; P = 0.03) than the premixed analogue group at follow-up. There were no significant differences in daily insulin dose and rates of hypoglycemia. Overall medication costs per 1.0{\%} reduction in HbA 1c were 841 with glargine/glulisine and 1308 with premixed analogues. Conclusions: Overall, treatment with glargine/glulisine provided greater improvement in glycemic control and may represent a more cost-effective treatment option than premixed regimens for patients with type 2 diabetes in real-world clinical practice. However, due to the pragmatic trial design, the study concluded before follow-up assessments were available for all randomized patients.",
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AU - Zhang, Quanwu

AU - Mersey, James H.

AU - Lee, Francis Y.

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N2 - Background: Cost can be an important consideration, along with safety and efficacy, in deciding the most appropriate treatment for patients with type 2 diabetes. Both basal-bolus and premixed insulin analogue regimens are widely used in clinical practice; however, limited information is available regarding cost-effectiveness. Objective: The goal of this study was to compare glycemic control, cost-effectiveness, and quality of life effects of insulin glargine plus insulin glulisine (glargine/glulisine) versus premixed insulin analogues in real-world clinical practice. Methods: Adults with type 2 diabetes (glycosylated hemoglobin [HbA 1c] 7.0%) at 3 US endocrinology centers were randomly assigned to receive either glargine/glulisine or premixed insulin analogues and continued treatment following the centers' usual practice. HbA 1c, weight, insulin dose, concomitant oral antidiabetic drug (OAD) usage, and hypoglycemia were evaluated at baseline and 3, 6, and 9 months. Medication costs, including costs for all insulin or OAD regimens, were estimated using published wholesale acquisition costs. Results: A total of 197 patients were randomized to receive glargine/glulisine therapy (n = 106) or premixed analogue therapy (n = 91). Overall, the mean age was 56 years, the mean duration of diabetes was 13 years, with a mean HbA 1c of 9.25% and mean BMI of 35.8 kg/m 2 at baseline. Patients randomized to receive glargine/glulisine had a greater mean HbA 1c reduction from baseline (-2.3%) than patients receiving a premixed analogue regimen (-1.7%). Adjusted mean follow-up HbA 1c was 6.9% versus 7.5%, respectively (difference, -0.59%; P <0.01). The glargine/glulisine group also used a lower mean number of OADs (0.86 vs 1.14; difference, -0.28; P = 0.04) but had a higher weight (240 vs 235 lb; difference, 4.55 lb; P = 0.03) than the premixed analogue group at follow-up. There were no significant differences in daily insulin dose and rates of hypoglycemia. Overall medication costs per 1.0% reduction in HbA 1c were 841 with glargine/glulisine and 1308 with premixed analogues. Conclusions: Overall, treatment with glargine/glulisine provided greater improvement in glycemic control and may represent a more cost-effective treatment option than premixed regimens for patients with type 2 diabetes in real-world clinical practice. However, due to the pragmatic trial design, the study concluded before follow-up assessments were available for all randomized patients.

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KW - Premixed insulin

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