Comparison of insulin detemir and insulin glargine using a basal‐bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes

Background This treat‐to‐target study compared the efficacy and safety of insulin detemir (IDet) and insulin glargine (IGla) in a basal‐bolus (insulin aspart) regimen in type 2 diabetes. Methods 385 patients were randomized 2 : 1 (IDet : IGla). Non‐inferiority of IDet to IGla was determined by HbA 1c 95% CI upper limit <0.4. Results IDet and IGla showed similar efficacy in HbA 1c reduction at 26 weeks, as the non‐inferiority criterion was met at 26 weeks (LS mean [Det–Gla]: 0.207; 95% CI: 0.0149,0.3995). It appeared that IGla in some cases did better than IDet in terms of HbA 1c , but the difference (0.207%) was not clinically meaningful. Based on the CONSORT guideline, non‐inferiority analysis using the LOCF approach was inconclusive regarding possible inferiority of delta 0.4 (LS mean of [Det–Gla]: 0.307; 95% CI: 0.1023, 0.5109). HbA 1c decreased significantly from baseline in IDet (−1.1% [26 weeks], −0.9% [LOCF], p < 0.001) and in IGla (−1.3% [26 weeks, LOCF], p < 0.001). Final HbA 1c were 7.1% (26 weeks) and 7.3% (LOCF) in IDet, and 6.9% (26 weeks) and 7.0% (LOCF) in IGla. Final FPG were 130 mg/dL (26 weeks) and 135 mg/dL (LOCF) in IDet, and 134 mg/dL (26 weeks) and 137 mg/dL (LOCF) in IGla. There was significantly less weight gain in IDet‐treated patients (1.2 ± 3.96 kg versus 2.7 ± 3.94 kg, p = 0.001). Hypoglycemia risk was comparable between groups. The majority of IDet‐treated patients (87.4%) remained on a once‐daily basal insulin regimen throughout the study. Conclusions IDet and IGla were both effective and safe treatments for glycemic control in a basal‐bolus regimen for type 2 diabetes. Clinically significant reductions in HbA 1c were achieved in both groups, but with significantly less weight gain in the IDet group at comparable basal insulin dosage. Copyright © 2009 John Wiley & Sons, Ltd.