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

L. Meneghini, J. Kesavadev, M. Demissie, A. Nazeri, P. Hollander

Research output: Contribution to journalArticlepeer-review

46 Scopus citations

Abstract

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) ≤90mg/dl (≤5.0mmol/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 26weeks were 38% and 53% (p=0.026) with detemir and glargine, respectively. FPG decreased ~43.2mg/dl (∼2.4mmol/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 -0.89kg). 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.

Original languageEnglish (US)
Pages (from-to)729-736
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume15
Issue number8
DOIs
StatePublished - Aug 2013

Keywords

  • Insulin detemir
  • Insulin glargine
  • Insulin initiation
  • Metformin
  • Oral antidiabetic drug

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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