Author(s): Raskin P, Gylvin T, Weng W, Chaykin L, Raskin P, Gylvin T, Weng W, Chaykin L
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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.
This article was published in Diabetes Metab Res Rev
and referenced in Journal of AIDS & Clinical Research