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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
Author(s) -
Meneghini L.,
Kesavadev J.,
Demissie M.,
Nazeri A.,
Hollander P.
Publication year - 2013
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12083
Subject(s) - medicine , insulin detemir , insulin glargine , metformin , type 2 diabetes , endocrinology , insulin , basal (medicine) , diabetes mellitus , gastroenterology , clinical endpoint , randomized controlled trial , glycemic , urology
Aims 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 ). Methods 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 . Results 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 a priori 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). Conclusion 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.