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Biphasic human insulin 30 thrice daily, is it reasonable?

ABSTRACT: OBJECTIVE:To evaluate the efficacy and safety of thrice daily Biphasic Human Insulin 30 (BHI 30) versus the traditional twice-daily regimen in type 2 diabetes mellitus (T2DM) patients. It's a cross over single clinical study. Twenty-two diabetic patients who were already using BHI 30 in twice or thrice daily regimens with or without metformin were included. At the 1st interval; patients continued on their usual insulin regimen as twice or thrice daily injections with adjustment of insulin doses guided by their glucose readings. On the 2nd interval; patients were switched to the other regimen with the same total daily insulin dose redistributed. RESULTS:There was a significant decrease in HbA1c level (p??0.05. On the other hand, patients had lower average blood glucose readings (mg/dl) when they were on thrice daily insulin injections (161.4?±?62.7) compared to twice daily regimen (166.0?±?69.5), p?

SUBMITTER: Saadeh NA

PROVIDER: S-EPMC7247174 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Biphasic human insulin 30 thrice daily, is it reasonable?

Saadeh Nesreen A NA Al-Azzeh Ola Y OY Khader Yousef S YS

BMC research notes 20200524 1

<h4>Objective</h4>To evaluate the efficacy and safety of thrice daily Biphasic Human Insulin 30 (BHI 30) versus the traditional twice-daily regimen in type 2 diabetes mellitus (T2DM) patients. It's a cross over single clinical study. Twenty-two diabetic patients who were already using BHI 30 in twice or thrice daily regimens with or without metformin were included. At the 1st interval; patients continued on their usual insulin regimen as twice or thrice daily injections with adjustment of insuli ...[more]

PMID: 32448382

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Project description:IntroductionEffective management of type 2 diabetes requires sustained glycemic control over many years, which can be particularly challenging for elderly people. This sub-analysis of the A1chieve study evaluated the clinical safety and effectiveness of biphasic insulin aspart 30 in 3 age-groups (≤40, >40-65, and >65 years) of previously insulin-experienced and insulin-naïve people with type 2 diabetes.MethodsA1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who had been receiving anti-diabetes medication before starting, or switching to, therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of biphasic insulin aspart 30 (±oral glucose-lowering drugs) in different age-groups.ResultsData on 40,122 participants were included. In all age-groups, the proportion of participants experiencing any hypoglycemia, major hypoglycemia or nocturnal hypoglycemia was significantly reduced from baseline, except for the following in insulin-naïve patients: a significant increase in any hypoglycemia in patients aged >65 years; no change in any hypoglycemia, major hypoglycemia, and nocturnal hypoglycemia in patients aged >40-65, ≤40, and >65 years, respectively. Significant improvements at 24 weeks vs. baseline were observed in insulin-experienced and insulin-naïve participants for: glycated hemoglobin (change from baseline ranged from -1.8% to -2.4%); fasting plasma glucose (from -3.0 to -4.3 mmol/l); post-breakfast post-prandial plasma glucose (from -4.1 to -6.5 mmol/l); and health-related quality of life (HRQoL). Sixteen serious adverse drug reactions were reported.ConclusionAfter 24-week treatment with biphasic insulin aspart 30, all age-groups of insulin-experienced and insulin-naïve patients experienced significantly improved glycemic control and HRQoL; incidence of hypoglycemia was generally reduced. The tolerability and effectiveness of biphasic insulin aspart 30 may benefit all age-groups.

Project description: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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Biphasic human insulin 30 thrice daily, is it reasonable?

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Biphasic human insulin 30 thrice daily, is it reasonable?

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