Biphasic Insulin Aspart 30 in Insulin-Naive People with Type 2 Diabetes in Non-western Nations: Results from a Regional Comparative Multinational Observational Study (A<sub>1</sub>chieve)

Shah, Siddharth; Yang, Wenying; Hasan, Mohammad Imtiaz; Malek, R.; Bech, Ole Molskov; Home, Philip

doi:10.1089/dia.2013.0074

Cited by 3 publications

(2 citation statements)

References 20 publications

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“…A common problem recorded was the poor degree of metabolic control (HbA1c ≈ 8 %), that coincides with data reported consistently in previous studies [ 7 , 9 , 10 , 30 ].…”

Section: Discussionsupporting

confidence: 90%

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data

Linetzky¹,

Curtis

Frechtel³

et al. 2016

Diabetol Metab Syndr

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BackgroundPoor glycemic control in patients with type 2 diabetes is commonly recorded worldwide; Latin America (LA) is not an exception. Barriers to intensifying insulin therapy and which barriers are most likely to negatively impact outcomes are not completely known. The objective was to identify barriers to insulin progression in individuals with type 2 diabetes mellitus (T2DM) in LA countries (Mexico, Brazil, and Argentina).MethodsMOSAIc is a multinational, non-interventional, prospective, observational study aiming to identify the patient-, physician-, and healthcare-based factors affecting insulin intensification. Eligible patients were ≥18 years, had T2DM, and were treated with insulin for ≥3 months with/without oral antidiabetic drugs (OADs). Demographic, clinical, and psychosocial data were collected at baseline and regular intervals during the 24-month follow-up period. This paper however, focuses on baseline data analysis. The association between glycated hemoglobin (HbA1c) and selected covariates was assessed.ResultsA trend toward a higher level of HbA1c was observed in the LA versus non-LA population (8.40 ± 2.79 versus 8.18 ± 2.28; p ≤ 0.069). Significant differences were observed in clinical parameters, treatment patterns, and patient-reported outcomes in LA compared with the rest of the cohorts and between Mexico, Brazil, and Argentina. Higher number of insulin injections and lower number of OADs were used, whereas a lower level of knowledge and a higher level of diabetes-related distress were reported in LA. Covariates associated with HbA1c levels included age (−0.0129; p < 0.0001), number of OADs (0.0835; p = 0.0264), higher education level (−0.2261; p = 0.0101), healthy diet (−0.0555; p = 0.0083), self-monitoring blood glucose (−0.0512; p = 0.0033), hurried communication style in the process of care (0.1295; p = 0.0208), number of insulin injections (0.1616; p = 0.0088), adherence (−0.1939; p ≤ 0.0104), and not filling insulin prescription due to associated cost (0.2651; p = 0.0198).ConclusionMOSAIc baseline data showed that insulin intensification in LA is not optimal and identified several conditions that significantly affect attaining appropriate HbA1c values. Tailored public health strategies, including education, should be developed to overcome such barriers.Trial Registration NCT01400971

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“…A common problem recorded was the poor degree of metabolic control (HbA1c ≈ 8 %), that coincides with data reported consistently in previous studies [ 7 , 9 , 10 , 30 ].…”

Section: Discussionsupporting

confidence: 90%

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data

Linetzky¹,

Curtis

Frechtel³

et al. 2016

Diabetol Metab Syndr

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“…In addition, switching from human insulin to premix analogues showed a similar positive safety profile. Evidence suggests that in insulin-naïve African subjects with T2DM, initiating once-daily premix insulin with or without OADs achieved better glycemic control than when compared with human insulin [ 90 ]. In a systematic review, short-term intensive insulin therapy was reported to improve the underlying pathophysiology in newly diagnosed T2DM.…”

Section: Type 2 Diabetes Mellitus (T2dm)mentioning

confidence: 99%

EADSG Guidelines: Insulin Therapy in Diabetes

et al. 2018

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Executive Summary and Recommendations A diagnosis of diabetes or hyperglycemia should be confirmed prior to ordering, dispensing, or administering insulin (A).Insulin is the primary treatment in all patients with type 1 diabetes mellitus (T1DM) (A).Typically, patients with T1DM will require initiation with multiple daily injections at the time of diagnosis. This is usually short-acting insulin or rapid-acting insulin analogue given 0 to 15 min before meals together with one or more daily separate injections of intermediate or long-acting insulin. Two or three premixed insulin injections per day may be used (A).The target glycated hemoglobin A1c (HbA1c) for all children with T1DM, including preschool children, is recommended to be < 7.5% (< 58 mmol/mol). The target is chosen aiming at minimizing hyperglycemia, severe hypoglycemia, hypoglycemic unawareness, and reducing the likelihood of development of long-term complications (B).For patients prone to glycemic variability, glycemic control is best evaluated by a combination of results with self-monitoring of blood glucose (SMBG) (B).Indications for exogenous insulin therapy in patients with type 2 diabetes mellitus (T2DM) include acute illness or surgery, pregnancy, glucose toxicity, contraindications to or failure to achieve goals with oral antidiabetic medications, and a need for flexible therapy (B).In T2DM patients, with regards to achieving glycemic goals, insulin is considered alone or in combination with oral agents when HbA1c is ≥ 7.5% (≥ 58 mmol/mol); and is essential for treatment in those with HbA1c ≥ 10% (≥ 86 mmol/mol), when diet, physical activity, and other antihyperglycemic agents have been optimally used (B).The preferred method of insulin initiation in T2DM is to begin by adding a long-acting (basal) insulin or once-daily premixed/co-formulation insulin or twice-daily premixed insulin, alone or in combination with glucagon-like peptide-1 receptor agonist (GLP-1 RA) or in combination with other oral antidiabetic drugs (OADs) (B).If the desired glucose targets are not met, rapid-acting or short-acting (bolus or prandial) insulin can be added at mealtime to control the expected postprandial raise in glucose. An insulin regimen should be adopted and individualized but should, to the extent possible, closely resemble a natural physiologic state and avoid, to the extent possible, wide fluctuating glucose levels (C).Blood glucose monitoring is an integral part of effective insulin therapy and should not be omitted in the patient’s care plan. Fasting plasma glucose (FPG) values should be used to titrate basal insulin, whereas both FPG and postprandial glucose (PPG) values should be used to titrate mealtime insulin (B).Metformin combined with insulin is associated with decreased weight gain, lower insulin dose, and less hypoglycemia when compared with insulin alone (C).Oral medications should not be abruptly discontinued when starting insulin therapy because of the risk of rebound hyperglycemia (D).Analogue insulin is as effective as human insulin but is a...

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Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis

Czech

Rdzanek²,

Paweska³

et al. 2015

BMC Endocr Disord

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BackgroundDiabetes mellitus (DM) leads to multiple complications, including severe hypoglycaemia events (SHEs). SHEs can impact a patient’s quality of life and compliance and may directly result in additional costs to the health care system. The aim of this review was to evaluate the risk of severe hypoglycaemia in patients with type 1 (T1) and 2 (T2) DM as observed in everyday clinical practice for various drug regimens.MethodsWe conducted a systematic review of observational (retrospective or prospective) studies in the MEDLINE, Embase, and Cochrane Library databases that covered at least 100 children or adults with T1/T2 DM. In T1 DM, basal-bolus/pre-mix insulin (human or analogue) and insulin pump were reviewed, and in T2 DM, basal-bolus/pre-mix insulin (human or analogue), oral antidiabetic drugs supported with basal insulin (human or analogue), sulfonylureas in monotherapy, and combined oral treatment were reviewed. In order to estimate SHE rates, we extracted data on the time horizon of the study, number of patients, number of SHEs, and number of patients experiencing at least one SHE. We used a random effects model to estimate the annual SHE rate. We considered the risk for other antidiabetic medications in T2 DM to be negligible and the results of our main review yielded no observational data for premixes in T1 DM so they were assessed based on relative rates taken from additional systematic reviews. The study, being a desk research, did not involve any human subjects (including human material or human data) and no ethical committee approval was asked for. For the same reason there was no need to collect informed consent for participation in the study.ResultsWe identified 76 observational studies encompassing 707,722.30 patient-years. The estimated annual SHE rate varied from 0.168 (95 % CI 0.123–0.237) for insulin pump up to 1.628 for biphasic human insulin in T1 DM patients, and from 0.0035 for oral antidiabetic drugs up to 0.554 (95 % CI 0.157–7.534) for basal-bolus with human insulin in T2 DM patients.ConclusionsOur review indicates that SHE rates differ between patients depending on treatment regimen. However, SHEs are also driven by other factors. Proper modelling techniques are needed to use various types of information in published studies.Electronic supplementary materialThe online version of this article (doi:10.1186/s12902-015-0052-z) contains supplementary material, which is available to authorized users.

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Biphasic Insulin Aspart 30 in Insulin-Naive People with Type 2 Diabetes in Non-western Nations: Results from a Regional Comparative Multinational Observational Study (A₁chieve)

Cited by 3 publications

References 20 publications

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data

EADSG Guidelines: Insulin Therapy in Diabetes

Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis

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Biphasic Insulin Aspart 30 in Insulin-Naive People with Type 2 Diabetes in Non-western Nations: Results from a Regional Comparative Multinational Observational Study (A1chieve)

Cited by 3 publications

References 20 publications

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data

Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data

EADSG Guidelines: Insulin Therapy in Diabetes

Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis

Contact Info

Product

Resources

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Biphasic Insulin Aspart 30 in Insulin-Naive People with Type 2 Diabetes in Non-western Nations: Results from a Regional Comparative Multinational Observational Study (A₁chieve)