التفاصيل البيبلوغرافية
| العنوان: |
Use of iGlarLixi for Management of Type 2 Diabetes in Japanese Clinical Practice: SPARTA Japan, a Retrospective Observational Study. |
| المؤلفون: |
Matsuhisa, Munehide1 (AUTHOR), Miyoshi, Hideaki2 (AUTHOR), Yabe, Daisuke3 (AUTHOR), Takahashi, Yoko4 (AUTHOR) Yoko.Takahashi@sanofi.com, Morimoto, Yukiko5 (AUTHOR), Terauchi, Yasuo6 (AUTHOR) |
| المصدر: |
Diabetes Therapy. Jan2023, Vol. 14 Issue 1, p219-236. 18p. |
| مصطلحات موضوعية: |
*TYPE 2 diabetes, *GLUCAGON-like peptide-1 receptor, *HYPERGLYCEMIA, *GLUCAGON-like peptide-1 agonists, *JAPANESE people, *GLYCEMIC control |
| مصطلحات جغرافية: |
SPARTA (Extinct city), JAPAN |
| مستخلص: |
Introduction: Many individuals with type 2 diabetes (T2D) experience suboptimal glycemic control. Treatment intensification options include fixed-ratio combination products containing a basal insulin and a glucagon-like peptide-1 receptor agonist, such as iGlarLixi (insulin glargine 100 U/mL and lixisenatide). This study aimed to provide real-world evidence of the effect of iGlarLixi in Japanese clinical practice. Methods: SPARTA Japan was a non-comparative, observational study conducted at 27 institutions in Japan. Anonymized individual-level data from adults with T2D receiving iGlarLixi in routine clinical practice were retrospectively collected. The primary study objective was to assess the impact of iGlarLixi on the change in glycated hemoglobin (HbA1c) at 6 months' post-treatment initiation, with preplanned subanalyses to determine the influence of baseline characteristics. Secondary and exploratory endpoints included assessment of the proportion of individuals achieving HbA1c targets, change in body weight, and incidence and severity of hypoglycemia and gastrointestinal events. Results: The full analysis set included 432 individuals, with data available at 6 months for 426. Of the 432 individuals, the mean (SD) age at baseline was 61.6 (12.8) years and the majority had a T2D duration of ≥ 10 years [mean (SD) 13.3 (10.4) years]. At 6 months, HbA1c had significantly decreased versus baseline (–0.85%; P < 0.0001), with a greater decrease in those aged < 65 years, with a shorter duration of T2D and higher baseline HbA1c. A significant increase in the proportion of participants achieving age-specific HbA1c versus baseline was observed. Mean body weight decreased by 0.5 kg (P = 0.0034 versus baseline). There were few hypoglycemia and gastrointestinal events (in individuals with HbA1c data); no severe hypoglycemic events were reported. Conclusions: The results of this real-world study indicate that iGlarLixi may improve glycemic control without serious adverse events in Japanese individuals with T2D who have suboptimal glycemic control on current treatment regimens and switch to iGlarLixi. Trial registration: UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021. Plain Language Summary: The first medicines for treating diabetes that many individuals with type 2 diabetes receive are administered orally; however, for most individuals, these oral drugs are not enough to achieve blood glucose targets as their disease progresses. Treatment intensification options include adding an injectable therapy, such as a glucagon-like peptide-1 receptor agonist or basal insulin, or the combination of both, the use of which has been studied extensively and has been shown to be a simple and well-tolerated option. Here, we report the findings of a study that retrospectively evaluated the outcomes of 432 Japanese individuals who took iGlarLixi, which consists of the glucagon-like peptide-1 receptor agonist lixisenatide and basal insulin glargine 100 U/mL as a fixed-ratio combination (i.e., combined as a single subcutaneous injection), over 6 months of treatment. We found that iGlarLixi improved blood glucose levels in these individuals, and was associated with few hypoglycemia or gastrointestinal adverse events. These results suggest that iGlarLixi may offer an effective option for improving glycemic control in Japanese individuals with type 2 diabetes who require treatment intensification because their blood glucose goals have not been achieved with oral drugs alone or co-administered with a glucagon-like peptide-1 receptor agonist or basal insulin. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
Full Text Finder