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

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) ≤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.

Observational Study of Patients in Morocco With Uncontrolled Type 2 Diabetes Treated With Metformin and/or Sulfonylurea With or Without Insulin

“…In a meta-analysis, comparing the efficacy of add-on anti-hyperglycemic drugs in pa tients with T2DM that were not controlled with metformin and sulfonylurea, a weight increase was seen with insulin (2.8 kg) [34]. Commonly, the achievement and maintenance of glycemic control over time is associated with weight gain [35][36][37]. However, in our study mean weight decreased significantly, even in the insulin cohort.…”

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“…Lower doses of glargine for equivalent glycaemic control P < 0.001 Hypoglycaemia similar P < 0.001 Meneghini, et al [33] (26 week randomised trial) Detemir versus glargine 38% detemir and 53% glargine achieved HbA1c < 7%…”

An international, multicenter, observational survey to evaluate diabetes control in subjects using insulin for the treatment of type 1 and type 2 diabetes mellitus in the Czech Republic and Slovak Republic: study protocol for a cross-sectional survey

“…20,21 Similarly unclear is the contribution of routinely used basal analogs, and the results of the studies cited herein, perhaps, slightly favor insulin glargine, especially with respect to type 2 diabetes. [22][23][24] This observational study could help answer these questions as well as questions related to the results of glycemic control for different types of insulin regimens in combination with oral antidiabetic agents in the treatment of type 2 diabetes.…”