Table 4.
Effect of Gla-100 on T1DM pediatric population.
| References | Study Design | Sample Size | Trial Duration | Treatment | HbA1c Change from Baseline (Recorded in the Same Order the Treatments have been Mentioned) | Frequency of Hypoglycemia (Recorded in the Same Order the Treatments have been Mentioned) | Comment |
|---|---|---|---|---|---|---|---|
| Abali et al. (2015) [52] | Retrospective | 117 | 2 years | Detemir Gla-100 |
8.9±2.1% 8.5±1.7% |
6.2 events/100 patients-years 14.1 events/100 patients-years |
Higher basal insulin doses of approximately 27% and more frequently, twice daily basal insulin injection are required to obtain similar glycemic control with insulin detemir. |
| Liu et al. (2016) [56] | Open-label, randomized, Phase III | 196 | 24 weeks | Gla-100 NPH |
-0.25±1.68% -0.54±1.67% |
68.6 events/ patients-years 84.6 events/ patients-years |
Initiation of insulin Gla-100 can aid Chinese pediatric people with T1DM to safely reduce their HbA1c levels. |
| Chase et al. (2008) [57] | Active-controlled, randomized, open-label, sex-stratified, 2-arm, parallel-group comparison | 175 | 24 weeks | Gla-100 NPH/Lente |
-0.18% -0.03% |
No significant differences between the groups for severe hypoglycemic events, or confirmed clinically relevant nocturnal hypoglycemic episodes. | Gla-100 is well tolerated in multiple daily injection regimens and may be more efficacious than NPH/Lente in those with elevated HbA1c. |
| Dixon et al. (2005) [58] | Retrospective | 128 | 6 months | Gla-100 NPH |
-0.1% +0.1% |
- | Severe hypoglycemia was decreased, particularly at night. |
| Schober et al. (2002) [59] | Multicenter, open-label, parallel group in children/ adolescents aged 5-16 years |
349 | 24 weeks | Gla-100 (bedtime) NPH (od or bd) |
0.28% (baseline NR) 0.27% (baseline NR) |
Symptomatic severe: 23% vs. 29% Nocturnal severe: 13% vs. 18% |
Once-daily Gla-100 provides effective glycemic control and is well tolerated in children and adolescents. |
| Päivärinta et al. (2008) [60] | Retrospective study | 62 | 16 months | Switched from NPH to insulin Gla-100 | 9.2% (baseline 9.2%) | No differences in the number of subjects having severe or nocturnal hypoglycemia | A switch to insulin Gla-100 retains a similar glycemic control and does not change the number of severe hypoglycemia. |
Abbreviations: Gla-100, glargine 100 U/mL; Gla-300, glargine 300 U/mL; HbA1c, glycated hemoglobin; NPH, neutral protamine Hagedorn; NR, not reported; T1DM, type 1 diabetes mellitus.