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

2009; Wiley; Volume: 25; Issue: 6 Linguagem: Inglês

10.1002/dmrr.989

1520-7560

Philip Raskin, Titus Gylvin, Wayne Weng, Louis Chaykin,

Metabolism, Diabetes, and Cancer

Abstract 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.