Twice-daily insulin glargine for patients with uncontrolled type 2 diabetes mellitus

Eledrisi, Mohsen; Suleiman, Noor; Salameh, Obada; Hamad, Mohammad; Rabadi, Omar; Mohamed, Ahmed S.; Adawi, Rana Al; Salam, Abdul

doi:10.1016/j.jcte.2018.12.002

Cited by 5 publications

(6 citation statements)

References 8 publications

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“…The indicated glucose-lowering effects, as observed with FPG and mean glucose levels, are mainly attributed to the impact of the long-acting insulin analog (IDeg) in the IDegAsp regimen. Previous studies reported the superiority of the twice-daily long-acting insulin regimen for glucose control compared with other regimens [ 11 , 33 ]. For example, twice-daily insulin glargine improved glycemic control in patients with uncontrolled diabetes after switching from a once-daily regimen to a twice-daily regimen [ 33 ].…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies reported the superiority of the twice-daily long-acting insulin regimen for glucose control compared with other regimens [ 11 , 33 ]. For example, twice-daily insulin glargine improved glycemic control in patients with uncontrolled diabetes after switching from a once-daily regimen to a twice-daily regimen [ 33 ]. Furthermore, twice-daily basal insulin treatment showed better glycemic control with a lower risk of hypoglycemia than both twice-daily neutral protamine Hagedorn (NPH) and once-daily basal insulin treatments [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and Safety of Insulin Degludec/Insulin Aspart Compared with a Conventional Premixed Insulin or Basal Insulin: A Meta-Analysis

et al. 2021

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Insulin degludec/insulin aspart (IDegAsp) is a novel co-formulation of 70% insulin degludec and 30% insulin aspart. The present meta-analysis was conducted to assess the efficacy and safety of IDegAsp compared with a conventional premixed insulin or basal insulin. We extracted data from citation databases, including PubMed, EMBASE, and the Cochrane Library, since inception to 2021. We calculated the mean differences for hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), self-measured mean glucose, and postprandial glucose (PPG) and odds ratios for confirmed hypoglycemia events. Compared with twice-daily conventional premixed insulin, twice-daily IDegAsp showed a similar effect on changes in HbA1c, but it significantly reduced FPG and self-measured mean glucose levels. Furthermore, compared to once-daily basal insulin, once-daily IDegAsp had a similar effect on changes in HbA1c, but it significantly reduced self-measured mean glucose and PPG levels. The risk of overall confirmed hypoglycemia was similar between treatments; however, the risk of nocturnal hypoglycemia events was significantly lower with IDegAsp than with conventional premixed insulin and basal insulin. Thus, IDegAsp was more effective than conventional premixed insulin and basal insulin at reducing blood glucose with fewer nocturnal hypoglycemia events.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Insulin Degludec/Insulin Aspart Compared with a Conventional Premixed Insulin or Basal Insulin: A Meta-Analysis

et al. 2021

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“…A third study found that twice/day insulin glargine resulted in a significant improvement in glucose control as measured by HbA 1c and concluded that twice/day insulin glargine was safe and efficacious . A recent study involving patients with uncontrolled type 2 DM reported similar findings as the report just cited and concluded that twice/day insulin glargine may be beneficial for some patients.…”

Section: Discussionmentioning

confidence: 68%

Insulin Glargine in Critically ill Patients: Once/Day versus Twice/Day Dosing

2020

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Objective Twice/day dosing of insulin glargine has been used to treat hyperglycemia in clinical practice; however, data supporting its use in the critically ill population are lacking. This study was designed to evaluate the safety and efficacy of twice/day insulin glargine in critically ill patients. Methods A retrospective study was conducted in adult patients admitted to the intensive care units between February 2013 and June 2017 who received insulin glargine twice/day or 40 units or more once/day for 48 hours or longer. Post cardiovascular surgery patients were excluded. Data were collected for up to 14 patient‐days. The efficacy outcomes included the incidence of hyperglycemia (blood glucose [BG] above 180 mg/dl), predose hyperglycemia rate (BG above 180 mg/dl within 4 hrs before the dose), and BG variability (standard deviation). The safety outcome was assessed by the development of hypoglycemia (BG below 70 mg/dl). Results A total of 58 patients (twice/day = 23; once/day = 35) were included in the analysis. Demographics were similar between the groups including history of diabetes mellitus, baseline hemoglobin A1C, and home insulin use. No difference was observed between the twice/day and once/day groups in the mean BG (153 vs 154 mg/dl, p=0.95, respectively), and BG variability (46 vs 44 mg/dl, p=0.29, respectively). Although the overall incidence of hyperglycemia was similar between twice/day and once/day groups (96% vs 97%, p=1.00, respectively), the twice/day group had a significantly lower predose hyperglycemia rate (twice/day 0.27 vs once/day 0.43, p=0.02). Additionally, the twice/day group did not experience an increased incidence of hypoglycemia (twice/day 23% vs once/day 34%, p=0.57) or hypoglycemia without having anything by mouth (twice/day 0% vs once/day 9%, p=0.27). Conclusions This is the first study demonstrating that twice/day insulin glargine reduced the rate of predose hyperglycemia without increasing the risk of hypoglycemia in critically ill patients. A large randomized study is needed to confirm the safety and efficacy of twice/day glargine in the critically ill.

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“…9,20 These modifications enhance the stability of the insulin molecule, resulting in delayed and prolonged absorption following a subcutaneous injection. 21 The global insulin glargine market was valued at US$ 6153.5 million in 2021, which represents half of the global basal insulin market share, and is forecast to reach a value of US$ 6257.7 million by 2028. 22 The insulin glargine of Gan & Lee Pharmaceutical, branded as Basalin ® , was successfully launched in China in 2005.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study

Christofides,

Puente,

Norwood

et al. 2024

Diabetes Obesity Metabolism

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AimTo evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus.MethodsThis was a phase 3, multicenter, open‐label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment‐induced anti‐insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment‐induced AIA development to the prespecified margins.ResultsThe percentages of participants positive for treatment‐induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of −2.1 percentage points and a 90% CI (−7.6%, 3.5%) (predefined similarity margins: −10.7%, 10.7%). The difference in glycated haemoglobin was −0.08% (90% CI, −0.23, 0.06). The overall percentage of participants with any treatment‐emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups.ConclusionsGL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study.

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Twice-daily insulin glargine for patients with uncontrolled type 2 diabetes mellitus

Cited by 5 publications

References 8 publications

Efficacy and Safety of Insulin Degludec/Insulin Aspart Compared with a Conventional Premixed Insulin or Basal Insulin: A Meta-Analysis

Efficacy and Safety of Insulin Degludec/Insulin Aspart Compared with a Conventional Premixed Insulin or Basal Insulin: A Meta-Analysis

Insulin Glargine in Critically ill Patients: Once/Day versus Twice/Day Dosing

Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study

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