Combined therapy with insulin lispro mix 75/25 plus metformin or insulin glargine plus metformin: A 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy

Malone, James; Kerr, Lisa; Campaigne, Barbara N.; Sachson, Richard; Holcombe, John H.

doi:10.1016/j.clinthera.2004.12.015

Cited by 158 publications

(168 citation statements)

References 14 publications

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“…While there is evidence to suggest that mixed and mealtime formulations improve glucose control, these formulations are also associated with an increased risk of hypoglycemia, as well as increased weight gain, and are not generally recommended as initial therapy. 5,[24][25][26][27] The 2012 updated guidelines make an exception for patients with HbA1c levels ≥ 9 %. 6 The low rates of treatment intensification and high rates of insulin discontinuation observed in this study suggest that patients remain at risk of inadequate glycemic control following insulin initiation.…”

Section: Discussionmentioning

confidence: 99%

Trends in Insulin Initiation and Treatment Intensification Among Patients with Type 2 Diabetes

et al. 2013

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BACKGROUND: Many patients with type 2 diabetes eventually require insulin, yet little is known about the patterns and quality of pharmacologic care received following insulin initiation. Guidelines from the American Diabetes Association and the European Association for the Study of Diabetes recommend that insulin secretagogues such as sulfonylureas be discontinued at the time of insulin initiation to reduce the risk of hypoglycemia, and that treatment be intensified if HbA1c levels remain above-target 3 months after insulin initiation. OBJECTIVE: To describe pharmacologic treatment patterns over time among adults initiating insulin and/or intensifying insulin treatment. DESIGN: Observational study. SUBJECTS: A large commercially insured population of adult patients without recorded type 1 diabetes who initiated insulin. MAIN MEASURES: We evaluated changes in noninsulin antidiabetic medication use during the 120 days immediately following insulin initiation, rates of increase in insulin dose and/or dosing frequency during the 270 days following an insulin initiation treatment period of 90 days, and rates of insulin discontinuation. KEY RESULTS: Seven thousand, nine hundred and thirty-two patients initiated insulin during [2003][2004][2005][2006][2007][2008], with the majority (61 %) initiating basal insulin only. Metformin (55 %), sulfonylureas (39 %), and thiazolidinediones (30 %) were commonly used prior to insulin initiation. Metformin was continued by 64 % of patients following mixed or mealtime insulin initiation; the continuation rate was nearly as high for sulfonylureas (58 %). Insulin dose and/or dosing frequency increased among 22.9 % of patients. Insulin was discontinued by 27 % of patients. CONCLUSIONS: We found evidence of substantial departures from guideline-recommended pharmacotherapy. Insulin secretagogues were frequently coprescribed with insulin. The majority of patients had no evidence of treatment intensification following

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Section: Discussionmentioning

confidence: 99%

Trends in Insulin Initiation and Treatment Intensification Among Patients with Type 2 Diabetes

et al. 2013

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“…Only one trial reported the occurrence of major events (requiring third-party assistance) in either group [45]. Minor hypoglycaemic events were significantly increased for biphasic insulin in five trials [36,38,39,43,45] with no difference reported in the remaining trials.…”

Section: Biphasic Vs Basal Insulinmentioning

confidence: 97%

“…Heterogeneity was not explained by fasting glucose target or baseline diabetic control. Of the remaining unpooled trials, two showed higher fasting glucose values in the biphasic group (in combined crossover data [38] or without reporting measures of dispersion [41]), one did not quote fasting values [40], one found no difference in fasting measures [43] and two with patients already taking insulin reported a higher percentage of the basal group reaching a target fasting value [44,45].…”

Section: Biphasic Vs Basal Insulinmentioning

confidence: 99%

“…HbA 1c Pooling five trials that presented appropriate data and recruited insulin-naive patients [36][37][38][39][40], showed that, compared with basal insulin, biphasic insulin reduced HbA 1c by a further 0.45% (95% CI 0.19-0.70, p=0.0006), but this varied considerably between studies (I 2 =66.1%) (Fig. 2a).…”

Section: Biphasic Vs Basal Insulinmentioning

confidence: 99%

“…Two trials did not report change in weight [41,42]. One reported weight loss with basal insulin in non-naive patients [45] and three crossover trials reported reduced weight gain with basal insulin without within-person differences [38,43,44]. Hypoglycaemia Pooled analysis was not possible due to variation in definitions of hypoglycaemia and lack of measures of dispersion.…”

Section: Biphasic Vs Basal Insulinmentioning

confidence: 99%

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Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses

et al. 2009

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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.

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Combination therapy in type 2 diabetes mellitus

Abdul‐Ghani

DeFronzo

Eldor³

2015

International Textbook of Diabetes Mellitus

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Combined therapy with insulin lispro mix 75/25 plus metformin or insulin glargine plus metformin: A 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy

Cited by 158 publications

References 14 publications

Trends in Insulin Initiation and Treatment Intensification Among Patients with Type 2 Diabetes

Trends in Insulin Initiation and Treatment Intensification Among Patients with Type 2 Diabetes

Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses

Combination therapy in type 2 diabetes mellitus

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