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A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-Naïve people with type 2 diabetes

Lookup NU author(s): Emeritus Professor Philip Home

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Abstract

OBJECTIVE - To assess efficacy and tolerability of insulin detemir or NPH insulin added to oral therapy for type 2 diabetes in a treat-to-target titration protocol. RESEARCH DESIGN AND METHODS - Individuals (n = 476) with HbA 1c (A1C) 7.5-10.0% were randomized to addition of twice-daily insulin detemir or NPH insulin in a parallel-group, multicenter trial. Over 24 weeks, insulin doses were titrated toward prebreakfast and predinner plasma glucose targets of ≤6.0 mmol/l (≤108 mg/dl). Outcomes assessed included A1C, percentage achieving A1C ≤7.0%, risk of hypoglycemia, and body weight. RESULTS - At 24 weeks, A1C had decreased by 1.8 and 1.9% (from 8.6 to 6.8 and from 8.5 to 6.6%) for detemir and NPH, respectively (NS). In both groups, 70% of participants achieved an A1C ≤7.0%, but the proportion achieving this without hypoglycemia was higher with insulin detemir than with NPH insulin (26 vs. 16%, P = 0.008). Compared with NPH insulin, the risk for all hypoglycemia with insulin detemir was reduced by 47% (P < 0.001) and nocturnal hypoglycemia by 55% (P < 0.001). Mean weight gain was 1.2 kg with insulin detemir and 2.8 kg with NPH insulin (P < 0.001), and the difference in baseline-adjusted final weight was -1.58 (P < 0.001). CONCLUSIONS - Addition of basal insulin to oral drug therapy in people with suboptimal control of type 2 diabetes achieves guideline-recommended A1C values in most people with aggressive titration. Insulin detemir compared with NPH insulin achieves this with reduced hypoglycemia and less weight gain. © 2006 by the American Diabetes Association.

Publication metadata

Author(s): Hermansen K, Davies M, Derezinski T, Ravn GM, Clauson P, Home P

Publication type: Article

Publication status: Published

Journal: Diabetes Care

Year: 2006

Volume: 29

Issue: 6

Pages: 1269-1274

Print publication date: 01/01/2006

ISSN (print): 0149-5992

ISSN (electronic): 1935-5548

Publisher: American Diabetes Association

URL: http://dx.doi.org/10.2337/dc05-1365

DOI: 10.2337/dc05-1365

PubMed id: 16732007

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