Insulin Glargine: a review 8 years after its introduction

Goykhman, Stanislav; Drincic, Andjela; Desmangles, Jean Claude; Rendell, Marc

doi:10.1517/14656560902775677

Cited by 44 publications

(18 citation statements)

References 114 publications

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“…These results confirm those observed in clinical studies with insulin glargine conducted in other countries [7]. In the present study, treatment of T2DM patients with insulin glargine for 6 months was associated with a reduction in HbA1c of 1.9±1.2% and a reduction in FBG of 108.1 ± 69.8 mg/dL.…”

Section: Discussionsupporting

confidence: 92%

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

et al. 2015

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Background:The aim of the study was to assess the real-life efficacy and safety of insulin glargine (Lantus ® , Sanofi) as a basal regimen in patients with type 2 diabetes mellitus (T2DM) who are poorly controlled with oral antidiabetic drugs (OADs) and/or other insulins.Methods: This observational, multicenter study was carried out in Morocco in 2011 and included 497 adult patients with T2DM and a baseline glycated hemoglobin (HbA1c) between 7.5% and 10.5% and for whom a basal regimen with insulin glargine was initiated. Two follow-up visits were scheduled at 12 and 26 weeks after starting treatment. The primary outcome target was HbA1c < 7%. Safety was assessed by the frequency of hypoglycemic episodes. Results:The target HbA1c level of < 7% was reached by 11.5% of patients after 3 months of insulin glargine treatment and 32% after 6 months. Mean HbA1c decreased significantly from 9.37±1.14% at baseline to 7.43±0.87% at 6 months (P < 0.001). Mean fasting blood glucose also decreased significantly from 237.5 ± 66.9 mg/dL at baseline to 129.5 ± 35.1 mg/dL at 6 months (P < 0.001). Approximately 12% of patients reported at least one hypoglycemic episode. No adverse event other than hypoglycemia was reported. Conclusions:This study shows that in a real-life setting, a basal regimen with insulin glargine significantly improves glycemic control in patients with T2DM who are inadequately controlled with OADs or other insulin regimens, with an acceptable hypoglycemia profile.

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Section: Discussionsupporting

confidence: 92%

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

et al. 2015

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Section: Discussionmentioning

confidence: 99%

“…Multiple studies have been conducted to compare NPH and glargine as basal insulin treatments for glycemic control in pediatric patients with type 1 diabetes in Caucasian populations, 10,11,13,15,[20][21][22] and conflicting results have been reported. Hathout et al 11 reported that the average HbA1c decreased from 9.5% to 8.6% (P < 0.001) after glargine administration, while the average glucose showed no significant change (210.67 mg/dL to 215.21 mg/dL, P > 0.5).…”

Section: Discussionmentioning

confidence: 99%

Insulin glargine in pediatric patients with type 1 diabetes in Japan

Urakami

Naito

Seino

2014

Pediatrics International

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BackgroundWe evaluated the safety and effectiveness of insulin glargine in Japanese pediatric patients with type 1 diabetes in clinical settings based on post-marketing surveillance data.MethodsClinical data were collected from Japanese pediatric patients with type 1 diabetes for 24 weeks after initiation of glargine treatment. Baseline characteristics, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), previous/concomitant medication, height, bodyweight, and adverse events were analyzed.ResultsOne-hundred and thirteen patients were enrolled from 20 medical institutions in Japan in 2003 and 2004. Of these patients, 73 were included in the safety analysis, and 70 of these patients were also included in the efficacy analysis. The 73 patients included 28 boys and 45 girls, with a mean age of 11.8 years at entry. Hypoglycemia occurred in three patients (three events) and was severe in two patients (two events); all patients recovered. In the efficacy evaluation, HbA1c at baseline and final assessment was 9.10% and 8.09% (P < 0.001) in all patients; 8.96% and 7.85% (P < 0.001) in patients aged 7–12 years (Group 1); and 9.28% and 8.37% (P = 0.010) in patients aged 13–15 years (Group 2). FPG significantly decreased in all patients and in Group 1. No significant changes were observed in body mass index or degree of obesity during the study.ConclusionsGlargine therapy for Japanese pediatric patients with type 1 diabetes resulted in good glycemic control in terms of HbA1c and FPG as well as good safety in clinical settings. Glargine had little effect on the physical build of patients.

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“…A review showed that nocturnal hypoglycemic episodes in patients with T1DM were significantly fewer among patients who received insulin glargine as compared with the patients who received Neutral Protamine Hagedorn (NPH) insulin. In addition, insulin glargine reduced glycosylated hemoglobin (HbA1c) levels to a greater extent as compared with NPH insulin [19]. Addition of bolus insulin to therapy with insulin glargine may further boost glycemic control [20].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Safety and Efficacy of Glaritus<sup>&reg;</sup> versus Lantus<sup>&reg;</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

Puppalwar¹,

Sawant²,

Silgiri³

et al. 2017

OJEMD

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Objective: The present study assessed safety and efficacy of Glaritus® among adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective, randomized, multicenter, comparative, non-inferiority, open-label, parallel group, phase IV study was conducted in 14 study centers in India. Subjects were randomly allocated to receive either Glaritus® or Lantus® for 12 weeks. Each week, the dose of insulin was titrated to maintain target fasting blood glucose (FBG) level range of 80 -120 mg/dL. Results: A total of 171 subjects were randomized (Glaritus® arm-86; Lantus® arm-85) and 161 subjects completed the study. The mean change in the glycosylated haemoglobin (HbA1c) levels from visit 3 (baseline) to visit 6 (end of trial) in Glaritus® arm was −0.69 ± 1.81 and in Lantus® arm was −0.53 ± 1.94. The mean change in glucose levels between week 1 and end of week 11 in Glaritus® arm was −8.81 ± 34.57 and in Lantus® arm was −5.28 ± 30. At least one hypoglycemic episode was experienced by 27.2% subjects of Glaritus® arm and 28.6% subjects of Lantus® arm. A total of 24 adverse events (AEs) such as pain, pyrexia, few infection related including urinary tract infections, metabolic related such as decreased appetite, musculoskeletal, neurological and skin related were re-

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Insulin Glargine: a review 8 years after its introduction

Cited by 44 publications

References 114 publications

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

Insulin glargine in pediatric patients with type 1 diabetes in Japan

Evaluation of Safety and Efficacy of Glaritus<sup>&reg;</sup> versus Lantus<sup>&reg;</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

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Insulin Glargine: a review 8 years after its introduction

Cited by 44 publications

References 114 publications

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

Observational Study of the Use of Insulin Glargine as Basal Therapy in Patients With Type 2 Diabetes Mellitus in Morocco

Insulin glargine in pediatric patients with type 1 diabetes in Japan

Evaluation of Safety and Efficacy of Glaritus&lt;sup&gt;&amp;reg;&lt;/sup&gt; versus Lantus&lt;sup&gt;&amp;reg;&lt;/sup&gt; in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

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Evaluation of Safety and Efficacy of Glaritus<sup>®</sup> versus Lantus<sup>®</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study