The effectiveness of lixisenatide as an add on therapy to basal insulin in diabetic type 2 patients previously treated with different insulin regimes: a multi-center observational study

Božek, Tomislav; Bilić-Ćurčić, Ines; Berković, Maja Cigrovski; Gradišer, Marina; Kurir, Tina Tičinović; Majanović, Sanja Klobučar; Marušić, Srečko

doi:10.1186/s13098-018-0321-x

Cited by 5 publications

(13 citation statements)

References 11 publications

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“…Many treatment algorithms and clinical trials of T2DM with beta cell death have been proposed so far [31][32][33][34] . Basal-Bolus, Basal plus, Basal supporting oral therapy (BOT), premixed insulins and premixed insulin and GLP-1R agonist were reported to improve safety and efficacy of the patient treated mainly in out-patient clinic [35][36][37][38][39][40][41][42] .…”

Section: Discussionmentioning

confidence: 99%

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

Nakashima

Okamura

Sanefuji

et al. 2020

Sci Rep

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the aim is to devise a new short-term intensive insulin therapy (n-Siit) based on the concept of "treat to target" to avoid hypoglycaemia and was applied it to various diabetic state. We determined dosage of 1 basal and 3 bolus "treat" insulin based on "target" blood glucose level and changed each insulin dose by small units (2 units) every day for 2 weeks. We evaluated the effects of N-SIIT in 74 subjects with type 2 diabetes (male 45, female 29, 64.9 ± 16.6 years old, HbA1c 10.4 ± 2.6%). Glargine U300 ("treat") and morning blood glucose level ("target") was significantly correlated with increasing insulin dose and decreasing blood glucose level in day 1-7, indicating that insulin amount was determined by target blood glucose level and lowered next target blood glucose level. Remission rates were 67.3% (Hypoglycaemia rate 5.6 %) in N-SIIT and 47.3% (Hypoglycaemia rate 38.1%) in conventional SIIT. Required amount of insulin would be automatically determined, depending on each patient pathophysiology and life style. This method is pretty simple, flexible and cheap, and provides information about the dynamic pathophysiological alteration of insulin resistance and glucotoxicity from the profile of blood glucose levels and insulin shot.Type 2 diabetes mellitus (T2DM) is a progressive disease which gradually reduces pancreatic beta-cell function such as insulin secretory capacity and increases insulin resistance in various insulin target tissues 1,2 . Recently, short-term intensive insulin therapy (SIIT) is recommended in the treatment of newly diagnosed T2DM to eliminate glucotoxicity, to reduce beta-cell overload (beta-cell rest effect), to support residual beta-cells and to enhance insulin sensitivity 3-18 .In addition, pancreatic alpha-cell dysfunction may contribute to the metabolic dysfunction found in diabetic state, because post-prandial paradoxical hyperglucagonaemia leads to the elevation of blood glucose levels 19,20 . SIIT may also improve alpha-cell physiology 21-23 . Indeed, it is possible that stepwise addition of insulin leads to the reduction of hyperglucagonaemia.The evidence of this treatment has been presented to prove benefits in the treatment of T2DM. However, in most SIIT studies, after SIIT they did not use any anti-diabetic agents and evaluated the duration of glycaemic remission [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] . As the results, glycaemic remission was temporary, especially when beta-cell function was markedly deteriorated after SIIT. Retnakaran et al. regarded SIIT as an induction therapy and sequential treatment with anti-diabetic agents as a maintenance therapy 24 . Several kinds of anti-diabetic agents such as metformin or GLP-1 receptor activator had been used for a maintenance therapy, but sometimes re-induction of insulin therapy was necessary [24][25][26][27] . We used conventional SIIT for the elimination of glucotoxicity in clinical practice and thought that SIIT was useful not only in newly diagnosed T2DM but also under many kinds of diabetes conditions to ...

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Section: Discussionmentioning

confidence: 99%

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

Nakashima

Okamura

Sanefuji

et al. 2020

Sci Rep

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“…The search terms are presented in Table S1. The search results were discussed by the author group and relevant articles were identified; 19–33 these are summarised in Tables 1 and 2 19–33 …”

Section: Methodsmentioning

confidence: 99%

“…During the 3–6‐month follow‐up period, transitioning from BBI to basal insulin and lixisenatide significantly reduced HbA1c (−22 mmol/mol [−2%]; p < 0.001), body weight (from 107 to 98 kg; p < 0.001) and TDD (−21.0 U; p = 0.006) (Table 2). 25 Hypoglycaemia data were not collected in this study.…”

Section: Overview Of the Clinical Evidence For Transitioning To A Com...mentioning

confidence: 98%

“…Božek and colleagues conducted a retrospective EHR analysis of the effectiveness of lixisenatide add‐on to basal insulin in 111 Croatian people with type 2 diabetes previously treated with basal insulin, BBI or premix insulin therapy 25 . At baseline, 15 participants had previously received BBI and they had a mean HbA1c of 81 mmol/mol (9.6%), 107 kg body weight and 71 U TDD (Table 2).…”

Section: Overview Of the Clinical Evidence For Transitioning To A Com...mentioning

confidence: 99%

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Transitioning from basal–bolus or premix insulin therapy to a combination of basal insulin and glucagon‐like peptide‐1 receptor agonist in people with type 2 diabetes

et al. 2022

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Aims: Two fixed-ratio combinations (FRCs) of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA) are available for once-daily use in adults with type 2 diabetes. We aimed to review the clinical evidence for the efficacy and safety of changing treatment from a basal-bolus insulin (BBI) regimen or a premix insulin to these combination treatments (fixed-ratio or loose) and provide expert opinion on the practicalities of making such a change. Methods: Relevant clinical and trial evidence and general review articles were identified through a literature review of ProQuest (comprising BIOSIS Previews®, Current Contents® Search, Embase® and MEDLINE®) for articles published between 2009 and 2021. Results:We identified nine articles reporting the results of FRCs, and seven articles reporting results of loose combinations of basal insulin and GLP-1RAs, in people who transitioned treatment from BBI or premix regimens. In most trials, combination treatment led to improved or equivalent glycaemic control, and a reduction in body weight or BMI, versus the original regimens. Some trials reported a reduction in total insulin dose. A few trials reported reduced or unchanged hypoglycaemia rates, or increased patient satisfaction, with combination therapy where these endpoints were examined. We provide guidance on transitioning of treatment and the patient types most likely to benefit. Conclusions:In people not achieving glycaemic control with BBI or premix insulin regimens, an FRC or loose combination of basal insulin and GLP-1RA may improve control, decrease the risk of body weight gain or hypoglycaemia and reduce the complexity of treatment.

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“…Lixisenatide, a once daily 7 , 9 short‐acting GLP‐1RA, improves glycemic control by increasing postprandial insulin secretion, delaying gastric emptying and reducing postprandial glucagon 10 . Various studies have reported that adding lixisenatide to basal insulin (BI) with or without other oral antidiabetic drugs led to significant reduction in glycated hemoglobin (HbA1c) levels in type 2 diabetes mellitus patients 9 , 11 , 12 , 13 , 14 . The results from these studies also showed that adding lixisenatide to BI led to weight reduction, as opposed to the usual weight gain, with lower risk of hypoglycemia and lower total insulin dose.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies

Liu

Liu³

et al. 2021

J of Diabetes Invest

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Aims/Introduction The prevalence and pathophysiological background of type 2 diabetes mellitus vary across ethnicities, and can affect treatment responses. Adding lixisenatide to basal insulin (BI) in type 2 diabetes mellitus patients has shown improvements in glycated hemoglobin (HbA1c) and postprandial glycemic (PPG) excursions, without increasing hypoglycemic events. We aim to compare the efficacy of lixisenatide in Asian and white patients inadequately controlled with basal insulin. Materials and Methods An individual‐level pooled analysis of two multi‐national phase III studies, GetGoal‐L and GetGoal‐L‐C, was carried out to assess the efficacy of lixisenatide versus placebo as an add‐on treatment to BI ± metformin in Asian and white patients with type 2 diabetes mellitus. Change in HbA1c, 2‐h PPG and PPG excursion were analyzed, along with possible predictors of glycemic control. Results Pooled data showed that baseline characteristics were similar between Asian and white patients with the exception of bodyweight, body mass index and BI dose being higher in white patients. After 24 weeks, lixisenatide reduced HbA1c in both ethnic groups, with no statistically significant difference between the two groups (Asian patients least squares mean difference −0.49, 95% confidence interval −0.68 to − 0.30 and white patients least squares mean difference −0.45, 95% confidence interval −0.63 to − 0.26; P = 0.6287). Similarly, no significant difference was found in 2‐h PPG reduction between both groups (least squares mean difference for Asian vs white patients: −3.37 vs −3.93; P = 0.3203). Treatment with lixisenatide contributed to HbA1c reduction of −0.56% after adjustment of baseline HbA1c level in Asian patients, and −0.41% in white patients. Conclusions Adding lixisenatide to BI significantly reduced HbA1c and 2‐h PPG levels in both Asian and white participants with type 2 diabetes mellitus. No differences in treatment effect were observed between the two populations.

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The effectiveness of lixisenatide as an add on therapy to basal insulin in diabetic type 2 patients previously treated with different insulin regimes: a multi-center observational study

Cited by 5 publications

References 11 publications

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

Transitioning from basal–bolus or premix insulin therapy to a combination of basal insulin and glucagon‐like peptide‐1 receptor agonist in people with type 2 diabetes

Efficacy of once‐daily glucagon‐like peptide‐1 receptor agonist lixisenatide as an add‐on treatment to basal insulin in Asian and white adults with type 2 diabetes mellitus: An individual‐level pooled analysis of phase III studies

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