medwireNews: Initiating insulin glargine (Gla-)300 U/mL could help half of those patients whose type 2 diabetes is inadequately controlled with oral antidiabetic medication to achieve their personal glycemic target within a year, real-world data suggest.
The Toujeo-1 prospective, observational, multicenter trial in 1748 insulin-naïve Swiss and German adults with poor glycemic control despite oral antidiabetic therapy revealed that initiating Gla-300 significantly lowered mean glycated hemoglobin (HbA1c) levels by 1.22% and mean fasting plasma glucose by 51.5 mg/dL after 12 months, without increasing the risk for nocturnal or severe hypoglycemia or weight gain.
Among the 721 eligible patients with data available at 12 months, from the 1153 patients included in the full analysis set after exclusion criteria were applied, 49.9% achieved the primary efficacy endpoint of reaching their individually predefined HbA1c target at least once within 12 months, while 33.4% achieved it within 6 months.
The secondary efficacy endpoint of target fasting plasma glucose (≤110 mg/dL [6.1 mmol/L]) was reached by 29.5% of participants assessed at 12 months, the researchers report in Diabetes, Obesity and Metabolism.
Overall, 61.1% achieved either their predefined HbA1c target or fasting plasma glucose target within 12 months, and both targets were achieved by 14.7%.
The mean starting dose of Gla-300 was 14.7 U/day, corresponding to 0.16 U/kg bodyweight and increased to a final dose of 26.2 U/day, corresponding to 0.28 U/kg bodyweight.
The mean HbA1c level at baseline was 8.52% (70 mmol/mol) and mean fasting plasma glucose was 184.2 mg/dL (10.2 mmol/L) and both reduced significantly with Gla-300 treatment at 6 and 12 months.
The authors note: “The median duration of HbA1c target achievement was 341 days (11.4 months), and the probability to remain on target 6 months after achieving control was 81%.”
Adverse events possibly related to Gla-300 use were reported in 2.1% of patients, most commonly general disorders and administration site conditions (0.6%) and benign, malignant, and unspecified neoplasms (0.5%).
There were no significant changes in confirmed, severe, or nocturnal and severe nocturnal hypoglycemia in the 12 weeks before starting Gla-300 versus the 12 weeks before the 6-month or 12-month assessments and bodyweight was unchanged.
However, there was a small but significant increase in symptomatic hypoglycemia after 12 months of Gla-300.
Martin Pfohl (Evangelisches Krankenhaus Bethesda, Duisburg, Germany) and colleagues note: “Slow titration appears to reduce the risk of hypoglycemia to a very low rate and to enable full development of blood glucose lowering potential of glargine insulins.”
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