A systematic literature search of PubMed (MEDLINE), EMBASE, and the Cochrane Central Register of controlled clinical trials databases was performed to identify studies published up to September 30, 2020 that compared the effects of Gla-100 to that of other
insulin regimens in people with T2DM. Relevant information pertaining to the predefined outcomes of interest was extracted.
Glycated hemoglobin (HbA1c) change and response rates along with overall
hypoglycemia incidence were the primary efficacy and safety outcomes of interest.
RESULTS: Seventy-nine studies (63 interventional and 16 non-interventional) in which Gla-100 was either initiated in previously
insulin-naïve patients (n = 57) or used in an intensified regimen (n = 22) were identified and evaluated. In
insulin-naïve patients, most studies demonstrated that Gla-100 was significantly better compared with premixed
insulins and similar compared with neutral
protamine Hagedorn (
NPH) insulin, second-generation basal
insulins, co-formulations, and other first-generation basal
insulins in terms of the primary efficacy parameters. Overall
hypoglycemia risk with Gla-100 was significantly lower compared with NPH, premixed, coformulation, and other first-generation basal
insulins and significantly higher compared with second-generation basal
insulins. In studies with intensified regimens, efficacy outcomes with Gla-100 were significantly better compared with
insulin detemir (IDet); similar compared with NPH, second-generation basal
insulins, co-formulations; and with premixed
insulins. In these studies, overall
hypoglycemia risk with Gla-100 was significantly lower compared with IDet and comparable to NPH, premixed
insulins, co-formulations, and second-generation basal
insulins. In addition, most intensification studies also revealed a significantly lower risk of nocturnal
hypoglycemia with Gla-100-based regimens versus NPH and premixed
insulins and a significantly greater risk compared to second-generation basal
insulins.
CONCLUSIONS: