Starting Insulin Therapy in Type 2 Diabetes: Twice-Daily Biphasic Insulin Aspart 30 Plus Metformin versus Once-Daily Insulin Glargine Plus Glimepiride

Kann, Peter Herbert; Wascher, Thomas C.; Žáčková, Viera; Moeller, J.; Medding, J.; Szocs, Albert; Mokáň, Marián; Mrevlje, Franc; Regulski, Matthew

doi:10.1055/s-2006-949655

Cited by 106 publications

(124 citation statements)

References 14 publications

(21 reference statements)

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“…As a result of the improved glycemic control, 64.5% patients in subject‐driven group met the HbA 1c target. Effective glycemic control was also reported in other trials where dose adjustment of BIAsp 30 BID was self‐decided by patients13, 14, 15, 16. The reduction of HbA 1c was 1.4–2.5% in those trials, which was similar to that reported in the present study.…”

Section: Discussionsupporting

confidence: 90%

Subject‐driven titration of biphasic insulin aspart 30 twice daily is non‐inferior to investigator‐driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open‐label, parallel‐group, multicenter trial

Yang

Zhu

Meng

et al. 2015

J of Diabetes Invest

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Aims/IntroductionThe present study was to compare the efficacy and safety of subject‐driven and investigator‐driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID).Materials and MethodsIn this 20‐week, randomized, open‐label, two‐group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self‐mixed human insulin were randomized 1:1 to subject‐driven or investigator‐driven titration of BIAsp 30 BID, in combination with metformin and/or α‐glucosidase inhibitors. Dose adjustment was decided by patients in the subject‐driven group after training, and by investigators in the investigator‐driven group.ResultsEligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject‐driven group and 14.3 mmol/mol (1.31%) in the investigator‐driven group. Non‐inferiority of subject‐titration vs investigator‐titration in reducing HbA1c was confirmed, with estimated treatment difference −0.26 mmol/mol (95% confidence interval −2.05, 1.53) (–0.02%, 95% confidence interval –0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self‐measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient‐year) was reported in the subject‐driven (1.10) and investigator‐driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject‐driven and investigator‐driven groups, respectively.ConclusionsSubject‐titration of BIAsp 30 BID was as efficacious and well‐tolerated as investigator‐titration. The present study supported patients to self‐titrate BIAsp 30 BID under physicians’ supervision.

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Section: Discussionsupporting

confidence: 90%

Subject‐driven titration of biphasic insulin aspart 30 twice daily is non‐inferior to investigator‐driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open‐label, parallel‐group, multicenter trial

Yang

Zhu

Meng

et al. 2015

J of Diabetes Invest

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“…102 Other studies have documented weight increases or weight stasis after treatment with glargine, although the weight increases, when observed, tended to be less than those occurring with NPH insulin. [103][104][105][106][107][108][109][110][111][112][113][114] The mechanisms behind the weight-sparing trait of insulin detemir have yet to be fully clarified. Insulin detemir is associated with a lower risk of hypoglycemia relative to other basal insulin preparations, 99,108,115 consistent with its greater pharmacokinetic predictability and smooth time-action profile.…”

Section: Weight Gainmentioning

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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“…The present study showed that exenatide + MET combination therapy was superior to BIA30 + MET combination therapy for the treatment of overweight or obese patients newly diagnosed with T2DM. It should be taken into account that in the present study, all patients were treated with a combination therapy, whereas only one report demonstrated that a double combination was beneficial for the therapy of T2DM patients (20); however, since the double and combination therapies involve subcutaneous injections of the agents at the same time twice daily and have the potential to favorably affect fasting and post-prandial glucose, they may be considered to be suitable interventions. Exenatide has been shown to improve glycemic control in patients with T2DM who failed to achieve glycemic control with maximally effective MET doses (29).…”

Section: Discussionmentioning

confidence: 88%

“…However, the effectiveness of the combination remains to be elucidated in overweight or obese patients with newly diagnosed type 2 diabetes mellitus. MET and BIA30 may reduce HbA (1c) and mean prandial plasma glucose increment to a greater extent in diabetic patients when compared with the patients treated with insulin glargine plus glimepiride (20). To the best of our knowledge, the efficacy of a combination therapy of MET and BIA30 has not yet been reported in specifically obese patients, only in general diabetic patients, and the efficacy and safety of the two combination therapies (exenatide or BIA30 and MET) in treating T2DM have not been previously compared, which was the purpose of the present study.…”

Section: Introductionmentioning

confidence: 98%

A crossover study of the combination therapy of metformin and exenatide or biphasic insulin aspart 30 in overweight or obese patients newly diagnosed with type 2 diabetes mellitus

Quan¹,

Zhang²,

Wei³

et al. 2017

Experimental and Therapeutic Medicine

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Abstract. The aim of the present study was to explore the effects of various combinations of exenatide, metformin (MET) and biphasic insulin aspart 30 (BIA30) on type 2 diabetes mellitus (T2DM). Two hundred overweight or obese patients newly diagnosed with T2DM were evenly randomized into two groups: A (twice daily for all: Phase I, 5 µg exenatide + 0.5 g MET for 4 weeks, then 10 µg exenatide + 0.5 g MET for 8 weeks; Phase II, 0.5 g MET for 12 weeks; Phase III, 0.3-0.4 U/kg/day BIA30 + 0.5 g MET for 12 weeks) and B (Phases I, II, III matched the phases III, II and I in group A). In groups A and B a significant decrease and increase, respectively, in glycated hemoglobin (HbAlc) and body mass index (BMI) was noted during Phase I. A 3.2±0.4-kg decrease in body weight in group A and a 2.6±0.3-kg increase in group B was observed. In Phase II, HbAlc was significantly increased in both groups (P<0.05). In Phase III, the BMI was increased in group A and reduced in group B (P<0.05). There was a 3.8±0.4-kg weight decrease in group B and 4.2±0.5-kg increase in group A (P<0.05). The combination of exenatide and MET promoted weight loss, glycemic control, β-cell function index, C peptide and adiponectin levels. These results suggested that the combination of exenatide and MET is better than the combination of BIA and MET for the therapy of overweight or obese patients newly diagnosed with T2DM.

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Starting Insulin Therapy in Type 2 Diabetes: Twice-Daily Biphasic Insulin Aspart 30 Plus Metformin versus Once-Daily Insulin Glargine Plus Glimepiride

Abstract: Starting insulin in Type 2 diabetes patients with twice-daily BIAsp 30 plus met can reduce HbA (1c) and mean prandial plasma glucose increment to a greater extent than once-daily glarg plus glim.

Cited by 106 publications

References 14 publications

Subject‐driven titration of biphasic insulin aspart 30 twice daily is non‐inferior to investigator‐driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open‐label, parallel‐group, multicenter trial

Subject‐driven titration of biphasic insulin aspart 30 twice daily is non‐inferior to investigator‐driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open‐label, parallel‐group, multicenter trial

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

A crossover study of the combination therapy of metformin and exenatide or biphasic insulin aspart 30 in overweight or obese patients newly diagnosed with type 2 diabetes mellitus

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