Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial

Bretzel, Reinhard G.; Nuber, Ulrike A.; Landgraf, Wolfgang; Owens, David R.; Bradley, Clare; Linn, Thomas

doi:10.1016/s0140-6736(08)60485-7

Cited by 290 publications

(241 citation statements)

References 40 publications

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“…Three reported greater reductions in PPG after all meals with prandial insulin [36,47,50] Weight Pooling six trials [36,37,[47][48][49][50] showed that, compared with basal insulin, prandial insulin increased weight gain by a further 1.86 kg (95% CI 0.80-2.92, p = 0.0006) (Fig. 2f) but this varied between studies (I 2 =85.4%).…”

Section: Prandial Vs Basal Insulinmentioning

confidence: 98%

“…HbA 1c Pooling seven trials [36,37,[46][47][48][49][50] showed that, compared with basal insulin, prandial insulin reduced HbA 1c by a further 0.45% (95% CI 0.16-0.73, p=0.002) (Fig. 2d) but with significant variation between the trials (I 2 =70.6%).…”

Section: Prandial Vs Basal Insulinmentioning

confidence: 99%

“…2e) but this varied considerably between studies (I 2 =44.0%). The SD of change was imputed in one trial [46], assuming a correlation of 0.35 calculated from a trial where data were available [47]. Heterogeneity was not explained by the use of OHAs, fasting targets, baseline diabetic control, titration reporting, use of analogue rather than conventional insulin or quality score.…”

Section: Prandial 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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Section: Prandial Vs Basal Insulinmentioning

confidence: 98%

Section: Prandial Vs Basal Insulinmentioning

confidence: 99%

Section: Prandial 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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“…The clinical trials showed that the use of basal insulin as an add‐on to OAD in patients with type 2 diabetes achieved 7% HbA1c, and approximately half of the patients experienced symptomatic hypoglycemia20, 21, 22, 23, 24. However, in real‐world practice, a retrospective USA study and two prospective studies in Ireland and Japan found that approximately just 20% of the patients taking basal insulin could achieve HbA1c <7% with a low rate of hypoglycemia16, 25, 26.…”

Section: Introductionmentioning

confidence: 99%

Glycemic control and adherence to basal insulin therapy in Taiwanese patients with type 2 diabetes mellitus

Chien

Chen²,

Hung

et al. 2016

J of Diabetes Invest

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Aims/IntroductionThe aim of the present study was to assess the glycemic control, adherence and treatment satisfaction in a real‐world setting with basal insulin therapy in type 2 diabetes patients in Taiwan.Materials and MethodsThis was a multicenter, prospective, observational registry. A total of 836 patients with type 2 diabetes taking oral antidiabetic drugs with glycated hemoglobin (HbA1c) >7% entered the study. Basal insulin was given for 24 weeks. All treatment choices and medical instructions were at the physician's discretion to reflect real‐life practice.ResultsAfter 24‐week treatment, 11.7% of patients reached set HbA1c goals without severe hypoglycemia (primary effectiveness end‐point). HbA1c and fasting blood glucose were significantly decreased from (mean ± SD) 10.1 ± 1.9% to 8.7 ± 1.7% (−1.4 ± 2.1%, P < 0.0001) and from 230.6 ± 68.8 mg/dL to 159.1 ± 55.6 mg/dL (−67.4 ± 72.3 mg/dL, P < 0.0001), respectively. Patients received insulin therapy at a frequency of nearly one shot per day on average, whereas self‐monitoring of blood glucose was carried out approximately four times a week. Hypoglycemia was reported by 11.4% of patients, and only 0.7% of patients experienced severe hypoglycemia. Slight changes in weight (0.7 ± 2.4 kg) and a low incidence of adverse drug reactions (0.4%) were also noted. The score of 7‐point treatment satisfaction rated by patients was significantly improved by 1.9 ± 1.7 (P < 0.0001).ConclusionsBasal insulin therapy was associated with a decrease in HbA1c and fasting blood glucose, and an improved treatment satisfaction. Most patients complied with physicians' instructions. The treatment was generally well tolerated by patients with type 2 diabetes, but findings pointed out the need to reinforce the early and appropriate uptitration to achieve treatment targets.

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“…The addition of a long‐acting insulin analog to oral agents, so‐called basal‐supported oral therapy (BOT), has been regarded as an effective option for initiating insulin therapy 6 . It can improve glycemic control with a simple regimen of titrating long‐acting insulin to target fasting glucose levels and is now widely used.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of liraglutide therapy in Japanese type 2 diabetic patients insufficiently controlled with basal‐supported oral therapy

Takahara

Shiraiwa²,

Ohtoshi³

et al. 2012

J of Diabetes Invest

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(J Diabetes Invest, doi: 10.1111/j.2040‐1124.2012.00223.x, 2012) Aims/Introduction: We assessed the efficacy of liraglutide therapy in Japanese type 2 diabetic patients insufficiently controlled with basal‐supported oral therapy (BOT).Materials and Methods: We retrospectively analyzed the data of 37 patients who had postprandial hyperglycemia (≥10.0 mmol/L) with BOT (long‐acting insulin plus glimepiride) with their insulin titrated enough to keep preprandial glycemia <7.2 mmol/L, and who had their treatment changed to liraglutide monotherapy, with the subsequent addition of glimepiride, when required. Those who achieved the glycemic target at all points (preprandial glycemia <7.2 mmol/L and postprandial glycemia <10.0 mmol/L) were regarded as responders and the efficacy of liraglutide therapy was assessed. We also explored the predictive clinical characteristics associated with its efficacy.Results: Daily doses of insulin and glimepiride with BOT were 14 ± 9 units and 1.5 ± 0.9 mg, respectively. After the change to liraglutide therapy, 37% of the patients appeared to be responders to the therapy, whereas 12% had their glycemic control rather deteriorated. Efficacy of liraglutide therapy was significantly associated with baseline insulin dosage and post‐breakfast glycemia with BOT. The C‐statistic of the model was calculated to be 0.90.Conclusions: There were responders and non‐responders to liraglutide therapy in Japanese BOT failures. It is likely that baseline insulin dosage and post‐breakfast glycemia with BOT are clinically useful indicators for the efficacy of liraglutide therapy.

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Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial

Cited by 290 publications

References 40 publications

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

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

Glycemic control and adherence to basal insulin therapy in Taiwanese patients with type 2 diabetes mellitus

Efficacy of liraglutide therapy in Japanese type 2 diabetic patients insufficiently controlled with basal‐supported oral therapy

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