Efficacy and Safety of Switching from Insulin Glargine 100 U/mL to the Same Dose of Glargine 300 U/mL in Japanese Type 1 and 2 Diabetes Patients: A Retrospective Analysis

Abstract

Objective Insulin glargine [300 U/mL (Gla-300)] achieved better glycemic control and reduced the risk of hypoglycemia in comparison to glargine [100 U/mL; (Gla-100)] in phase 3 trials. This is the first study to retrospectively evaluate the efficacy and safety of Gla-300 in Japanese type 1 and 2 diabetes patients in a routine clinical setting. Methods We analyzed 20 type 1 diabetes patients and 62 type 2 diabetes patients who switched from Gla-100 to the same dose of Gla-300. Sixty type 2 diabetes patients who continued the use of Gla-100 during the study were included as controls. Results At three months after switching, the HbA1c levels were decreased in the patients with type 1 diabetes, but not to a significant extent. In the type 2 diabetes patients, the HbA1c levels were significantly decreased after switching (p<0.01). In contrast, there was no change in the HbA1c levels of the type 2 diabetes patients who continued the use of Gla-100 over the same period. The BMI values of the type 1 diabetes patients tended to decrease (p=0.06) and there was a significant decrease in the BMI values of the type 2 diabetes patients (p<0.05). There was no change in the BMI values of the type 2 diabetes patients who continued the use of Gla-100. The rates of hypoglycemia and adverse events did not change during the follow-up period. Conclusion In the clinical setting, switching from Gla-100 to the same dose of Gla-300 had a favorable effect on glycemic control and body weight control in Japanese type 1 and type 2 diabetes patients, without any increase in adverse events; however, a prospective study should be performed to confirm these findings.

Twenty Years of Insulin Gla-100: A Systematic Evaluation of Its Efficacy and Safety in Type 2 Diabetes Mellitus

“…1 ), the search yielded 13,942 hits; of which 79 studies were included in the final list for data extraction, including 63 interventional and 16 non-interventional studies. There were 57 studies (Table 1 ) wherein Gla-100 was initiated in either insulin-naïve or previously Gla-100 -naïve patients [ 6 – 62 ]and 22 studies (Table 2 ) wherein Gla-100 was used in an intensified regimen [ 63 – 85 ].…”

“…There were 57 studies (Table 1 ) wherein Gla-100 was initiated in either insulin-naïve or previously Gla-100 -naïve patients [ 6 – 62 ]and 22 studies (Table 2 ) wherein Gla-100 was used in an intensified regimen [ 63 – 85 ].…”

“…In the 57 studies reporting the results of efficacy and safety of insulin initiation, the mean HbA1c level at baseline was > 8% with values ranging from 7.55 [ 6 ] to 10.3% [ 7 ]. The mean (SD) baseline FPG value ranged from 133.2 (34.2) mg/dL [ 8 ] to 194.4 mg/dL [ 9 ], whereas the baseline PPG value was reported in only five studies and ranged from 205.2 (61.2) mg/dL [ 10 ] to 363.78 (110.34) mg/dL [ 11 ].…”

“…The mean (SD) baseline FPG value ranged from 133.2 (34.2) mg/dL [ 8 ] to 194.4 mg/dL [ 9 ], whereas the baseline PPG value was reported in only five studies and ranged from 205.2 (61.2) mg/dL [ 10 ] to 363.78 (110.34) mg/dL [ 11 ]. Similarly, the mean (SD) bodyweight of included patients ranged from 61.9 (9.29) kg [ 12 ] to 108 (25.7) kg [ 13 ] (Table 3 ) [ 6 – 62 ].…”

“…Similarly, the mean (SD) bodyweight of included patients ranged from 61.9 (9.29) kg [ 12 ] to 108 (25.7) kg [ 13 ] (Table 3 ) [ 6 – 62 ].…”