Titration of insulin glargine 100 U/mL when added to oral antidiabetic drugs in patients with type 2 diabetes: results of the TOP-1 real-world study

Pscherer, Stefan; Anderten, Helmut; Pfohl, Martin; Fritsche, Andreas; Borck, Anja; Pegelow, Katrin; Bramlage, Peter; Seufert, Jochen

doi:10.1007/s00592-019-01383-w

Cited by 7 publications

(8 citation statements)

References 32 publications

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“…This difference might, when compared with the once‐weekly dose adjustment applied in EDITION 3, be attributed to the much more cautious dose titration of once every 2 weeks, even in the first weeks of titration observed in our study (data on file). We found a similar titration frequency in the real world with Gla‐100 . Slow titration appears to reduce the risk of hypoglycaemia to a very low rate and to enable the full development of the blood glucose‐lowering potential of glargine insulins.…”

Section: Discussionsupporting

confidence: 59%

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Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

Pfohl

Jornayvaz

Fritsche

et al. 2020

Diabetes Obesity Metabolism

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Aim: To evaluate the effectiveness and safety of initiating basal insulin-supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs). Materials and Methods:This non-interventional, multi-centre, prospective 52-week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla-300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target.Results: Of 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla-300 treatment. Twelve months after starting Gla-300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by −1.22% ± 1.05% to 7.28% ± 0.92% and mean FPG by −51.5 (±48.63) mg/dl to 132.9 ± 33.0 mg/dL. Median duration of HbA1c target achievement was 341 days and probability to remain on target after 6 months was 81%. Hypoglycaemia incidence and rates remained low after 12 months of Gla-300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged.Conclusions: Starting a BOT regimen with Gla-300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12 months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia. K E Y W O R D Sglycaemic control, hypoglycaemia, insulin analogues, observational study, type 2 diabetes

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Section: Discussionsupporting

confidence: 59%

“…Slow titration appears to reduce the risk of hypoglycaemia to a very low rate and to enable the full development of the blood glucose‐lowering potential of glargine insulins. However, insulin titration was finished quite early in both observational studies, resulting in some patients missing their glycaemic targets.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

Pfohl

Jornayvaz

Fritsche

et al. 2020

Diabetes Obesity Metabolism

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“…We found similar titration frequencies in real-world BI initiation with Gla-300 24 and Gla-100. 25,26 Slow titration appears to reduce the risk of hypoglycaemia to very low rates and to enable better development of the blood glucose lowering potential of glargine insulins. This is supported by the findings of King, who previously found a BI dose of about 0.2 U/kg/day to cover BI requirements in many patients with T2D.…”

Section: Discussionmentioning

confidence: 99%

Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety

Seufert

Wiesli

Fritsche

et al. 2021

Diabetes Obesity Metabolism

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Aims: This study evaluated the effectiveness and safety of switching the basal insulin (BI) in a BI-supported oral therapy (BOT) to insulin glargine 300 U/ml (Gla-300) in adults with inadequately controlled type 2 diabetes (T2D). Materials and methods:This was a non-interventional, multicentre, prospective 12-month study, conducted in Germany, Austria and Switzerland. The study documented people with T2D with glycated haemoglobin (HbA1c) between 7.5% and 10.0%, currently treated by a non-Gla-300 BOT regimen, after the physician had decided to switch the BI to Gla-300. Primary endpoint was the proportion of patients achieving the fasting plasma glucose (FPG; ≤110 mg/dl) target.Results: In total, 1194 participants comprised the full analysis set, of which 793 completed documentation of 12 months Gla-300 treatment (FAS-M12). The main previous BI was insulin glargine 100 U/ml (Gla-100; 47.2%). Twelve months after switching to Gla-300, 27.0% of FAS-M12 participants achieved the FPG target and 44.8% their individualized HbA1c target. The greatest FPG target achievements were seen in previous Gla-100 (29.3%), and greatest HbA1c target achievements in previous insulin detemir users (57.7%). The mean FPG decreased by À36.3 ± 51.2 mg/dl to 135.5 ± 36.9 mg/dl and mean HbA1c by À0.79 ± 1.01% to 7.45 ± 0.94%. Symptomatic and nocturnal hypoglycaemia incidence significantly decreased over 12 months of Gla-300 treatment. Body weight remained unchanged.Conclusions: Switching the BI to Gla-300 in a BOT regimen improved metabolic control and treatment satisfaction in a substantial proportion of patients with T2D and inadequate target achievement within 12 months in clinical practice with a decreased risk of symptomatic and nocturnal hypoglycaemia and without weight gain.

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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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Titration of insulin glargine 100 U/mL when added to oral antidiabetic drugs in patients with type 2 diabetes: results of the TOP-1 real-world study

Cited by 7 publications

References 32 publications

Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

Switching the basal insulin to insulin glargine 300 U/ml in people with type 2 diabetes under basal insulin supported oral therapy: Observational trial on effectiveness and safety

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

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