Switching from Premixed Human Insulin to Premixed Insulin Lispro: A Prospective Study Comparing the Effects on Glucose Control and Quality of Life

Yamada, Satoru; Watanabe, Mari; Kitaoka, Akira; Shiono, Kaoru; Atsuda, Koichiro; Tsukamoto, Youko; Kawana, Yukiko; Irie, Junichiro

doi:10.2169/internalmedicine.46.0236

Cited by 24 publications

(40 citation statements)

References 11 publications

(3 reference statements)

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“…The study populations had a median hemoglobin A1c of 8.7 percent (range: 7.3 to 10.7 percent), a median body mass index of 29.4 kg/m 2 (range: 24 to 37 kg/m 2 ), and a median duration of diabetes of 11 years (range: 4 to 16 years). Eleven trials enrolled insulin-naïve patients (9;18;19;27;29;33;34;36;38;43;44), 26 enrolled insulin-treated patients (23;25;28;32;34;35;37;39-42;45-55;57-60), and nine did not specify history of insulin treatment (17;20-22;24;26;30;31;56). …”

Section: Resultsmentioning

confidence: 99%

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

et al. 2008

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Background Evidence comparing premixed insulin analogues with other antidiabetic agents is urgently required to guide appropriate therapy. Purpose To summarize the English-language literature on the effectiveness and safety of premixed insulin analogues as compared with other antidiabetic agents in adults with type 2 diabetes. Data Sources We searched MEDLINE®, EMBASE®, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to February 2008, and unpublished data from U.S. Food and Drug Administration, European Medicines Agency, and industry. Study Selection Studies with control arms that compared premixed insulin analogues to another antidiabetic medication in adults with type 2 diabetes Data Extraction Serial abstraction by 2 reviewers using standardized protocols Data Synthesis Evidence from clinical trials was inconclusive for clinical outcomes, such as mortality. Therefore, the review focused on intermediate outcomes. Premixed analogues were similar to premixed human insulin in lowering fasting glucose, hemoglobin A1c, and the incidence of hypoglycemia but were more effective in lowering postprandial glucose (mean difference = -1.1 mmol/L; 95% CI = -1.4 to -0.7 mmol/L [-19.2 mg/dL; 95% CI=-25.9 to -12.5 mg/dL]). As compared to long-acting insulin analogues, premixed analogues were superior in lowering postprandial glucose (mean difference= -1.5 mmol/L; 95%CI = -1.9 to -1.2 mmol/L [-27.9 mg/dL; 95% CI=-34.3 to -21.5 mg/dL]) and hemoglobin A1c (mean difference=-0.39%; 95% CI=-0.50% to -0.28%) but inferior in lowering fasting glucose (mean difference=0.7 mmol/L; 95%CI = 0.3 to 1.0 mmol/L [12.0 mg/dL; 95% CI=6.0 to 18.1 mg/dL]) and had higher incidence of hypoglycemia. When compared to noninsulin antidiabetic agents, premixed analogues were more effective in lowering fasting glucose (mean difference= -1.1mmol/L; 95%CI = -1.7 to 0.6 mmol/L [-20.5 mg/dL; 95% CI=-29.9 to -11.2 mg/dL]), postprandial glucose (mean difference= -2.1 mmol/L; 95%CI = -3.4 to -0.8 mmol/L [-37.4 mg/dL; 95% CI=-61.0 to -13.7 mg/dL]), and hemoglobin A1c (mean difference=-0.49%; 95% CI=-0.86% to -0.12%) but had higher incidence of hypoglycemia. Limitations Searching was restricted to studies published in English. Data on clinical outcomes was limited. The small number of studies for each comparison limited assessment of between-study heterogeneity. Conclusions Premixed insulin analogues provide glycemic control similar to premixed human insulin and may provide tighter glycemic control than long-acting insulin analogues and noninsulin antidiabetic agents.

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Section: Resultsmentioning

confidence: 99%

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

et al. 2008

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“…56 In the third study, a crossover design study of 28 adolescent subjects, there was no significant difference in HbA1c between subjects treated with glargine/lispro and those treated with NPH/regular insulin, each for 16 weeks (8.7% vs. 9.1%; P=0.13). 55 A number of studies have assessed HbA1c levels in patients treated with premixed human insulins versus those treated with premixed insulin analogs, including premixed insulin lispro formulations [57][58][59] and insulin aspart formulations. [60][61][62] While one study showed small but significant improvements in HbA1c levels after treatment with 50/50 premixed insulin lispro relative to premixed human insulins, 57 other studies failed to find similar advantages favoring premixed insulin analogs.…”

Section: Clinical Effects Of Insulin Analogs Hba1cmentioning

confidence: 99%

“…55 A number of studies have assessed HbA1c levels in patients treated with premixed human insulins versus those treated with premixed insulin analogs, including premixed insulin lispro formulations [57][58][59] and insulin aspart formulations. [60][61][62] While one study showed small but significant improvements in HbA1c levels after treatment with 50/50 premixed insulin lispro relative to premixed human insulins, 57 other studies failed to find similar advantages favoring premixed insulin analogs. 58,60,62 Consistently, however, patients receiving premixed insulin analogs exhibited improved PPG control relative to premixed human insulins, reflecting the higher absorption rate of the analogs.…”

Section: Clinical Effects Of Insulin Analogs Hba1cmentioning

confidence: 99%

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

Hartman

2008

Clinical Medicine & Research

115

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Despi te 85 years of research since Banting and Best's isolation of insulin-containing extracts, 1 diabetes still remains one of the most significant causes of morbidity and mortality in the world, and its global impact is likely to accelerate over the coming decades. 2,3 Much of the medical and economic consequences of diabetes are attributable to its associated microvascular and macrovascular complications. [4][5][6] Two classic large-scale clinical studies, the Diabetes Control and Complications Trial (DCCT) 6 and the UK Prospective Diabetes Study (UKPDS), 7 demonstrated that intensive blood-glucose control policies can decrease the frequency of complications, arguing that physicians and patients should strive to mimic, as closely as possible, the serum levels of insulin produced by a healthy person. Secretion of insulin by the pancreas, however, is under complex regulation that depends on the intake of nutrients, other gastrointestinal peptides (e.g., incretins), and overall metabolic levels (i.e., exercise versus rest). 8 These physiological variables, which pose real challenges to the accurate metabolic replacement of insulin, are further complicated by the fact that diabetes requires self-management and therefore depends on the psychology, motivation, and understanding of the patient. A growing body of medical research has demonstrated that intensive control of serum glucose levels can minimize the development of diabetes-related complications. Success with insulin management ultimately depends on how closely a given regimen can mimic normal physiologic insulin release patterns.The new insulin analogs, including the rapid-acting analogs (aspart, lispro, glulisine), the long-acting basal analogs (glargine, detemir), and the premixed insulin analog formulations (75% neutral protamine lispro, 25% lispro; 50% neutral protamine lispro, 50% lispro; 70% protamine aspart, 30% aspart) have been formulated to allow for a closer replication of a normal insulin profile.The rapid-acting analogs can be administered at mealtimes and produce a rapid and short-lived insulin spike to address postprandial glucose elevations, while the long-acting analogs come close to the ideal of a smooth, relatively flat, 24-hour basal insulin supply, with less variability in action compared to NPH insulin. Despite these clear pharmacologic advantages, measurable clinical benefits in a complex disease such as diabetes can be hard to measure.To date, reviews of insulin analog studies have not found a dramatic overall improvement in glycosylated hemoglobin (HbA1c) outcomes compared to traditional human insulins, although all-analog basal-bolus regimens were associated with significantly lower HbA1c than all-human-insulin basal bolus regimens in some studies. Beyond HbA1c comparisons, however, insulin analogs have been shown in many instances to be associated with lower risks of hypoglycemia, lower levels of postprandial glucose excursions, better patient adherence, greater quality of life, and higher satisfaction with treatment.The long-act...

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“…3 April 2011 JMCP Supplement to Journal of Managed Care Pharmacy S11 aspart 70/30 was less effective than premixed human insulin in reducing fasting glucose (pooled mean difference = 8.3 mg/dL; 95% CI = 0.16 to 16.5 mg/dL; P = 0.04). In 1 of 2 trials on insulin lispro 50/50, 47 no difference in fasting glucose change was observed between the premixed analogue and NPH/regular 70/30. However, in the second trial, 46 insulin lispro 50/50 was less effective than the premixed human insulin preparation (mean difference = 30.0 mg/dL; P < 0.001).…”

Section: Figurementioning

confidence: 95%

“…• Insulin aspart 70/30 versus NPH/regular 70/30-3 parallel-arm trials 31,33,34 and 3 crossover trials [35][36][37] • Insulin lispro 75/25 versus NPH/regular 70/30 or NPH/regular 50/50-9 randomized crossover studies [37][38][39][40][41][42][43][44][45] and 1 retrospective observational study 28 • Insulin lispro 50/50 versus NPH/regular 70/30 or NPH/ regular 50/50-3 randomized crossover studies 38,41,46 and 1 parallel-arm study 47 The studies varied considerably in therapy administration methods, dosing schedules, and duration.…”

Section: Premixed Insulin Analogues Versus Premixed Human Insulinmentioning

confidence: 99%

AHRQ's Comparative Effectiveness Research on Premixed Insulin Analogues for Adults with Type 2 Diabetes: Understanding and Applying the Systematic Review Findings

Qayyum¹,

Greene²

2011

JMCP

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experience includes numerous meta-analytic studies on treatments for conditions such as type 2 diabetes, hypertension, acute coronary syndromes, and the effectiveness of continuing medical education. His research has been supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. He serves as Associate Editor of the Journal of Hospital Medicine and is a member of the Society of Hospital Medicine, the American Heart Association, and the American College of Physicians. ) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PRIME ® designates this Journal-Based CME activity for a maximum of 2.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Pharmacist Accreditation StatementThis curriculum has been approved for 2.5 contact hours by PRIME ® . PRIME ® is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The universal program number for this activity is 0255-0000-11-004-HO1-P. This learning activity is Knowledge-based. Nurse Accreditation Statement PRIME Education, Inc. (PRIME ® ) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. PRIME ® designates this activity for 2.5 contact hours. Case Manager Accreditation StatementThe Commission for Case Manager Certification designates this educational activity for 2.0 contact hours for certified case managers. AHRQ's Comparative Effectiveness Research on Premixed Insulin Analogues for Adults with Type 2 Diabetes: Understanding and Applying the Systematic Review Findings Credit Instructions:In order to receive CME/CE credit for this program, you must: 1. Review this program in its entirety 2. Access www.ce.effectivehealthcare.ahrq.gov/credit and enter program code CER1 3. Complete the post-test (70% passing score) and evaluation online 4. Print your CME/CE statement immediately following the evaluation DISCLOSURESQayyum produced this program under contract with PRIME Education, Inc. (PRIME ® ). Greene is an employee of PRIME ® . The authors report no financial or other conflicts of interest related to the subjects in this report. Mooradian, Jarvis, Gunning, and Valdez report no financial or other conflicts of interest related to the subjects in this report.Brixner reports consultant relationships with Novo Nordisk, Novartis, and Abbott Laboratories, and grant funds paid to her institution from Bristol-Myers Squibb and Novo Nordisk. Campbell reports participation in the speakers bureau for Eli Lilly. Neumiller reports grant funds paid to his institution from Amylin, Johnson & Johnson, Merck, and Novo Nordisk. Quilliam reports grant funds paid to his institution from Takeda and Ortho-McNeil Janssen. ACKNOWLEDGEMENTSThe authors acknowledge Diana I. Brixner, RPh, PhD, and Karen M. Gunning, PharmD, of the University of Utah Departme...

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Switching from Premixed Human Insulin to Premixed Insulin Lispro: A Prospective Study Comparing the Effects on Glucose Control and Quality of Life

Abstract: Aim

Cited by 24 publications

References 11 publications

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

AHRQ's Comparative Effectiveness Research on Premixed Insulin Analogues for Adults with Type 2 Diabetes: Understanding and Applying the Systematic Review Findings

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