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Keywords:

  • insulin glargine;
  • premixed insulin;
  • type 2 diabetes mellitus

OBJECTIVES: To compare initiation of insulin therapy by adding once-daily insulin glargine to oral antidiabetic agents (OADs) with switching patients to premixed 30% regular, 70% human neutral protamine hagedorn insulin (70/30) without OADs.

DESIGN: A 24-week, multicenter, open, randomized (1:1), parallel study.

SETTING: Three hundred sixty-four poorly controlled patients with type 2 diabetes mellitus were treated with once-daily morning insulin glargine with continued OADs (glimepiride+metformin) (glargine+OAD) or twice-daily 70/30 alone. Insulin dosage in each group was titrated to target fasting blood glucose (FBG) of 100 mg/dL or less (≤5.6 mmol/L) using a weekly titration algorithm.

PARTICIPANTS: This planned subgroup analysis of the original study was based on 130 insulin-naive patients aged 65 and older with FBG of 120 mg/dL or greater (≥6.7 mmol/L) and hemoglobin (Hb)A1c levels between 7.5% and 10.5% on OADs (glargine+OAD, n=67; 70/30, n=63).

MEASUREMENTS: HbA1c, FBG, hypoglycemia, insulin dose, and adverse events were recorded.

RESULTS: HbA1c decreased from baseline to endpoint for both glargine+OAD (from 8.8% to 7.0%) and 70/30 (from 8.9% to 7.4%); adjusted mean HbA1c decrease for glargine+OAD and 70/30 was −1.9% and −1.4%, respectively (P=.003). More patients reached HbA1c of 7.0% or less without confirmed nocturnal hypoglycemia with glargine+OAD (n=37, 55.2%) than with 70/30 (n=19, 30.2%) (P=.006). FBG decreased significantly more with glargine+OAD (−57 mg/dL (−3.2 mmol/L)) than with 70/30 (−40 mg/dL (−2.2 mmol/L)) (P=.002). Patients treated with glargine+OAD experienced fewer episodes of any hypoglycemia (3.68/patient–year) than did those treated with 70/30 (9.09/patient–year) (P=.008).

CONCLUSION: In elderly patients, addition of once-daily morning glargine+OAD is a simple regimen to initiate insulin therapy, restoring glycemic control more effectively and with less hypoglycemia than twice-daily 70/30 alone.