Data from this manuscript were presented in poster format at the American Diabetes Association, San Diego, California, 2005; Diabetes 2005;54(Suppl 1):A144 (Abstract 583).
Combination of Oral Antidiabetic Agents with Basal Insulin Versus Premixed Insulin Alone in Randomized Elderly Patients with Type 2 Diabetes Mellitus
Article first published online: 18 JAN 2007
Journal of the American Geriatrics Society
Volume 55, Issue 2, pages 182–188, February 2007
How to Cite
Janka, H. U., Plewe, G. and Busch, K. (2007), Combination of Oral Antidiabetic Agents with Basal Insulin Versus Premixed Insulin Alone in Randomized Elderly Patients with Type 2 Diabetes Mellitus. Journal of the American Geriatrics Society, 55: 182–188. doi: 10.1111/j.1532-5415.2007.01043.x
- Issue published online: 18 JAN 2007
- Article first published online: 18 JAN 2007
- 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.