Once‐daily initiation of basal insulin as add‐on to metformin: a 26‐week, randomized, treat‐to‐target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Issue 8 (13th March 2013)

• Record Type: Journal Article
• Authors: Meneghini, L.; Kesavadev, J.; Demissie, M.; Nazeri, A.; Hollander, P.
• Is Part Of: Diabetes, obesity & metabolism. Volume 15:Issue 8(2013:Aug.)
• Page Start: 729
• Page End: 736
• Publication Date: 2013-03-13
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12083
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main"> <title>ABSTRACT</title> <sec id="dom12083-sec-0001" sec-type="section"> <title>Aims</title> <p>This study assessed the efficacy and safety of once‐daily insulin initiation using insulin detemir (detemir) or insulin glargine (glargine) added to existing metformin in type 2 diabetes (T2D).</p> </sec> <sec id="dom12083-sec-0002" sec-type="section"> <title>Methods</title> <p>This 26‐week, multinational, randomized, treat‐to‐target trial involved 457 insulin‐naïve adults with T2D (HbA1c 7–9%). Detemir or glargine was added to current metformin therapy [any second oral antidiabetic drug (OAD) discontinued] and titrated to a target fasting plasma glucose (FPG) ≤90 mg/dl (≤5.0 mmol/l). Primary efficacy endpoint was change in HbA1c.</p> </sec> <sec id="dom12083-sec-0003" sec-type="section"> <title>Results</title> <p>Mean (s.d.) HbA1c decreased with detemir and glargine by 0.48 and 0.74%‐points, respectively, to 7.48% (0.91%) and 7.13% (0.72%) [estimated between‐treatment difference, 0.30 (95% CI: 0.14–0.46)]. Non‐inferiority for detemir at the <italic>a priori</italic> level of 0.4%‐points was not established. The proportions of patients reaching HbA1c ≤ 7% at 26 weeks were 38% and 53% (p = 0.026) with detemir and glargine, respectively. FPG decreased ∼43.2 mg/dl (∼2.4 mmol/l) in both groups [non‐significant (NS)]. Treatment satisfaction was good for both insulins. Hypoglycaemia, which occurred infrequently, was observed less with detemir than glargine [rate ratio 0.73 (95% CI 0.54–0.98)]. The proportions of patients reaching HbA1c ≤ 7% without hypoglycaemia in the detemir and glargine groups were 32% and 38% (NS), respectively. Weight decreased with detemir [−0.49 (3.3) kg] and increased with glargine [+1.0 (3.1) kg] (95% CI for difference: −2.17 to −0.89 kg).</p> </sec> <sec id="dom12083-sec-0004" sec-type="section"> <title>Conclusion</title> <p>While both detemir and glargine, when added to metformin therapy, improved glycaemic control, glargine resulted in greater reductions in HbA1c, while detemir demonstrated less weight gain and hypoglycaemia.</p> </sec> </abstract>