Safety of basal-bolus versus premixed insulin intensification regimens in the management of type 2 diabetes mellitus: A narrative review of a 14-year experience (original) (raw)
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2014
Background: Type 2 Diabetes Mellitus (T2DM) is a chronic condition due to insulin resistance or relative insulin deficiency. Although insulin intensification regimens are commonly prescribed for the management of T2DM, there is uncertainty regarding their optimal use. We conducted a 13 Year narrative review to compare outcomes of these regimens in the treatment of T2DM. Method: We searched electronic databases (PubMed, Scopus, Proquest and Google Search), and “grey literature” from January 2000 to December 2013 to identify studies comparing insulin intensification regimens. Results: Out of 17 studies identified, we only included 10 studies specifically comparing Basal-Bolus regimens (BB) versus Pre-mixed Insulin Regimens (PM). Seven trials comparing regimens other than the studied regimens; with study duration lesser than 12 weeks; or involving Type 1 diabetes mellitus patients were excluded. The outcomes measured were divided into safety and efficacy parameters. Among the safety ou...
Diabetes, Obesity and Metabolism, 2009
Aims: Insulin analogues are widely used but few data exist comparing different analogue regimens. We compared two such regimens in type 2 diabetes mellitus (T2DM) uncontrolled by oral antidiabetic agents (OADs) with or without basal insulin. Methods: In a 26-week multinational, multicentre, randomized treat-to-target trial, OADs were discontinued and subjects randomized to analogue basal-bolus therapy (insulin detemir once daily and insulin aspart mealtimes) or biphasic insulin aspart 30 (30% rapid-acting insulin aspart), twice daily. Insulin was titrated to targets for fasting, predinner and postprandial plasma glucose (PG), as appropriate. Results: Of 719 subjects, 92% completed the study; 58% achieved haemoglobin fraction A 1c (HbA 1c ) 7.0%, with reductions of 1.56% (to 6.96%) with basal-bolus therapy and 1.23% (to 7.17%) with biphasic insulin aspart. Reduction with basal-bolus therapy was superior in the overall population by 0.23% (p ¼ 0.0052), with no difference between regimens in insulin-naive patients. Major hypoglycaemia occurred in five basal-bolus patients (0.9%) and in no patients with biphasic insulin aspart. Incidence of minor hypoglycaemia was similar in both groups. All insulin doses increased during titration, with increase in lunchtime insulin aspart dose and equal distribution of breakfast and dinner biphasic insulin aspart doses. Insulin detemir remained once daily in 87% of patients. Conclusions: Modern insulin analogue regimens, adjusted to PG targets, enable a majority of people with T2DM to reach HbA 1c 7.0% after failure of OADs and OAD-basal insulin therapy. Insulin-treated patients may benefit more from transfer to analogue basal-bolus therapy, while insulin-naive individuals benefit equally well from the more convenient biphasic analogue regimen.
Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses
Diabetologia, 2009
Aims/hypothesis We compared the effect of biphasic, basal or prandial insulin regimens on glucose control, clinical outcomes and adverse events in people with type 2 diabetes. Methods We searched the Cochrane Library, MEDLINE, EMBASE and major American and European conference abstracts for randomised controlled trials up to October 2008. A systematic review and meta-analyses were performed. Results Twenty-two trials that randomised 4,379 patients were included. Seven trials reported both starting insulin dose and titration schedules. Hypoglycaemia definitions and glucose targets varied. Meta-analyses were performed pooling data from insulin-naive patients. Greater HbA 1c reductions were seen with biphasic and prandial insulin, compared with basal insulin, of 0.45% (95% CI 0.19-0.70, p=0.0006) and 0.45% (95% CI 0.16-0.73, p=0.002), respectively, but with lesser reductions of fasting glucose of 0.93 mmol/l (95% CI 0.21-1.65, p = 0.01) and 2.20 mmol/l (95% CI 1.70-2.70, p<0.00001), respectively. Larger insulin doses at study end were reported in biphasic and prandial arms compared with basal arms. No studies found differences in major hypoglycaemic events, but minor hypoglycaemic events for prandial and biphasic insulin were inconsistently reported as either higher than or equivalent to basal insulin. Greater weight gain was seen with prandial compared with basal insulin (1.86 kg, 95% CI 0.80-2.92, p=0.0006). Conclusions/interpretation Greater HbA 1c reduction may be obtained in type 2 diabetes when insulin is initiated using biphasic or prandial insulin rather than a basal regimen, but with an unquantified risk of hypoglycaemia. Studies with longer follow-up are required to determine the clinical relevance of this finding.
Medical Sciences, 2021
Evidence suggests a major contribution of postprandial glucose (PPG) excursions to the increased risk of micro- and macro-vascular complications in individuals with type 2 diabetes mellitus (T2DM). Administration of bolus insulin remains a very effective therapeutic option for PPG control. The aim of this expert group recommendation document was to provide practical and easy-to-execute guidelines for physicians on the appropriate use of bolus insulin in the management of T2DM. A panel of key opinion leaders from India reviewed and discussed the available clinical evidence and guideline recommendations on the following topics: (1) optimum control of PPG; (2) choice of bolus insulin; and (3) special situations and practical considerations. The expert panel critically analyzed the current literature and clinical practice guidelines and factored their rich clinical experience to develop a set of nine expert group recommendations for the effective use of bolus insulin. These recommendati...
Vascular Health and Risk Management, 2015
Background: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatment needs to be continuously intensified to avoid long-term complications. In T2DM patients on either basal insulin-supported oral therapy (BOT) or supplementary insulin therapy (SIT) presenting with HbA 1c values above individual targets for 3-6 months, therapy should be intensified. This study investigated effectiveness and tolerability of an intensification of BOT or SIT to a basal-bolus therapy (BBT) regimen in T2DM patients in daily clinical practice. Methods: This noninterventional, 8-month, prospective, multicenter study evaluated parameters of glucose control, occurrence of adverse events (eg, hypoglycemia), and acceptance of devices in daily clinical practice routine after 12 and 24 weeks of intensifying insulin therapy to a BBT regimen starting from either preexisting BOT with insulin glargine (pre-BOT) or preexisting SIT with $3 daily injections of insulin glulisine (pre-SIT). Results: A total of 1,530 patients were documented in 258 German medical practices. A total of 1,301 patients were included in the full analysis set (55% male, 45% female; age median 64 years; body mass index median 30.8 kg/m 2 ; pre-BOT: n=1,072; pre-SIT: n=229), and 1,515 patients were evaluated for safety. After 12 weeks, HbA 1c decreased versus baseline (pre-BOT 8.67%; pre-SIT 8.46%) to 7.73% and 7.66%, respectively (∆ mean-0.94% and-0.80%; P,0.0001). At week 24, HbA 1c was further reduced to 7.38% and 7.30%, respectively (∆ mean-1.29% and-1.15%; P,0.0001), with a mean reduction of fasting blood glucose values in both treatment groups by more than 46 mg/dL. An HbA 1c goal of #6.5% was reached by 17.9% (pre-BOT) and 18.6% (pre-SIT), and an HbA 1c #7.0% by 46.1% (pre-BOT) and 43.0% (pre-SIT) of patients. During 24 weeks, severe as well as serious hypoglycemic events were rare (pre-BOT: n=5; pre-SIT: n=2; pretreated with both insulins: n=1). Conclusion: Intensifying glargine-based BOT or glulisine-based SIT to a BBT regimen in poorly controlled T2DM patients in daily routine care led to marked improvements of glycemic control and was well tolerated.
Endocrinología y nutrición : órgano de la Sociedad Española de Endocrinología y Nutrición, 2013
To assess in standard clinical practice the feasibility, efficacy, and safety of switching patients with long-standing type 2 diabetes (T2DM) and poor or unstable blood glucose control to basal-bolus insulin therapy. This was a prospective, single center study including 37 patients with T2DM (age 65±8 years, 62.2% men, body mass index 28.8±6.2 kg/m2, diabetes duration 18±8 years) with poor or unstable glycemic control, who were switched to a basal-bolus insulin regimen with glargine and rapid-acting insulin analogue at the discretion of their physicians. After a group-structured outpatient diabetes training program, patients were followed in a clinical practice setting for 6 months. Clinical and biochemical variables were collected before switching and at 3 and 6 months. After switching to basal-bolus therapy, glycosylated hemoglobin (HbA1c) decreased from 9±1.2% to 8.1±1.2% (p<0.001) at 3 months and to 8.0±1.2% at 6 months (p<0.001) without changing total daily insulin dose. ...
Vascular Health and Risk Management, 2015
Background: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatment needs to be continuously intensified to avoid long-term complications. In T2DM patients on either basal insulin-supported oral therapy (BOT) or supplementary insulin therapy (SIT) presenting with HbA 1c values above individual targets for 3-6 months, therapy should be intensified. This study investigated effectiveness and tolerability of an intensification of BOT or SIT to a basal-bolus therapy (BBT) regimen in T2DM patients in daily clinical practice. Methods: This noninterventional, 8-month, prospective, multicenter study evaluated parameters of glucose control, occurrence of adverse events (eg, hypoglycemia), and acceptance of devices in daily clinical practice routine after 12 and 24 weeks of intensifying insulin therapy to a BBT regimen starting from either preexisting BOT with insulin glargine (pre-BOT) or preexisting SIT with $3 daily injections of insulin glulisine (pre-SIT). Results: A total of 1,530 patients were documented in 258 German medical practices. A total of 1,301 patients were included in the full analysis set (55% male, 45% female; age median 64 years; body mass index median 30.8 kg/m 2 ; pre-BOT: n=1,072; pre-SIT: n=229), and 1,515 patients were evaluated for safety. After 12 weeks, HbA 1c decreased versus baseline (pre-BOT 8.67%; pre-SIT 8.46%) to 7.73% and 7.66%, respectively (∆ mean-0.94% and-0.80%; P,0.0001). At week 24, HbA 1c was further reduced to 7.38% and 7.30%, respectively (∆ mean-1.29% and-1.15%; P,0.0001), with a mean reduction of fasting blood glucose values in both treatment groups by more than 46 mg/dL. An HbA 1c goal of #6.5% was reached by 17.9% (pre-BOT) and 18.6% (pre-SIT), and an HbA 1c #7.0% by 46.1% (pre-BOT) and 43.0% (pre-SIT) of patients. During 24 weeks, severe as well as serious hypoglycemic events were rare (pre-BOT: n=5; pre-SIT: n=2; pretreated with both insulins: n=1). Conclusion: Intensifying glargine-based BOT or glulisine-based SIT to a BBT regimen in poorly controlled T2DM patients in daily routine care led to marked improvements of glycemic control and was well tolerated.
Insulin intensification for people with type 2 diabetes: a practical approach
Australasian medical journal, 2010
Background: Type 2 diabetes is a progressive disorder and with time, it is appropriate for insulin therapy to be initiated in the majority of people. Insulin is commonly initiated with once-daily basal insulin. However, when glycaemic control becomes unsatisfactory despite the introduction of basal insulin, no clear guidelines exist for intensifying the insulin regimen. In this article we aim to provide a clinician's approach to both the optimisation of the basal insulin dose, and strategies to intensify insulin therapy. Methods: An expert consensus panel, consisting of the authors, was convened to review the current practice of insulin intensification in people with type 2 diabetes and to develop a pragmatic algorithm for clinicians. The panel reviewed the published literature on the use of insulin in clinical practice, the evidence for different intensification strategies, and the potential impact of patient-related factors on insulin choices. Results: Insulin intensification should only be considered after the basal insulin dose has been optimised. This is achieved by taking into account basal and prandial (pre and post) blood glucose levels, individualised target HbA 1c , and dietary factors. If optimal basal insulin together with oral medications is not sufficient to reach glycaemic targets, the next step is to introduce a basal plus 1 regimen or switch to twice-daily premixed insulin. Each has advantages and disadvantages and existing guidelines do not emphasise or support any particular regimen. Therefore, it is important to individualise the choice according to the individual's needs. A practical algorithm has been developed to help clinicians choose an appropriate second-line regimen. Conclusion: As beta-cell failure progresses in people with type 2 diabetes, basal insulin regimens need to be optimised and then intensified when necessary to maintain agreed glycaemic targets.