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-naive people with type 2 diabetes

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, A1 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.