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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

¹ Department of Endocrinology and Metabolism, Aarhus Sygehus THG, Aarhus University Hospital, Aarhus, Denmark
² University Hospitals of Leicester, Leicester Royal Infirmary, Leicester, U.K.
³ Out-Patient Clinic, NZOZ Eskulap, Gniewkowo, Poland
⁴ Out-Patient Clinic, Novo Nordisk, Bagsværd, Denmark
⁵ School of Medical Sciences–Diabetes, University of Newcastle upon Tyne, Newcastle upon Tyne, U.K.

Address correspondence and reprint requests to Professor Kjeld Hermansen, Department of Endocrinology and Metabolism, Aarhus Sygehus THG, Aarhus University Hospital, DK-8000 Aarhus C, Denmark. E-mail: kjeld.hermansen{at}as.aaa.dk

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.

Abbreviations: FPG, fasting plasma glucose • ITT, intention-to-treat • OGLD, oral glucose-lowering drug

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