Abstract
BackgroundThe purpose of this analysis is to evaluate the safety and effectiveness of insulin initiation with once-daily insulin detemir (IDet) or insulin glargine (IGlar) in real-life clinical practice in Turkish patients with type 2 diabetes mellitus (T2DM).MethodsThis was a 24-week multinational observational study of insulin initiation in patients with T2DM.ResultsThe Turkish cohort (n = 2886) included 2395 patients treated with IDet and 491 with IGlar. The change in glycosylated haemoglobin (HbA1c) from the pre-insulin levels was -2.21% [95% confidence interval (CI) -2.32, -2.09] in the IDet group and -1.88% [95% CI -2.17, -1.59] in the IGlar group at the final visit. The incidence rate of minor hypoglycaemia increased in both groups from the pre-insulin to the final visit (+0.66 and +2.23 events per patient year in the IDet and IGlar groups, respectively). Weight change in the IDet group was -0.23 kg [95% CI -0.49, 0.02 kg], and +1.55 kg [95% CI 1.11, 2.00 kg] in the IGlar group. Regression analysis with adjustment for previously identified confounders (age, gender, duration of diabetes, body mass index, previous history of hypoglycaemia, microvascular disease, number and change in oral anti-diabetic drug therapy, HbA1c at baseline and insulin dose) identified an independent effect of insulin type (IDet versus IGlar) with a risk of at least one episode of hypoglycaemia (odds ratio (OR): 0.33 [95% CI 0.21, 0.52], p <0.0001), and weight loss ≥1 kg (OR: 1.75 [95% CI 1.18, 2.59], p = 0.005), but not on HbA1c (+0.05% [95% CI -0.15, 0.25%], p = 0.6).ConclusionsInitiation of basal insulin analogues, IDet and IGlar, were associated with clinically significant glycaemic improvements. A lower risk of minor hypoglycaemia and greater odds of weight loss ≥1 kg was observed with IDet compared with IGlar.Trial registrationNCT00825643 and NCT00740519
Highlights
The purpose of this analysis is to evaluate the safety and effectiveness of insulin initiation with once-daily insulin detemir (IDet) or insulin glargine (IGlar) in real-life clinical practice in Turkish patients with type 2 diabetes mellitus (T2DM)
Basal insulin formulations have been continuously improved over the years and have become widely used as they have many pharmacodynamic and pharmacokinetic advantages over neutral protamine Hagedorn (NPH) insulin including a longer duration of action, reduced variable absorption profiles and a reduced marked peak effect [3]
Insulin detemir and insulin glargine are widely used as add-on therapies for patients not responding to oral anti-diabetic drug (OAD) regimens, but there are few studies directly comparing the two insulin analogues in routine care [4,5,6]
Summary
The purpose of this analysis is to evaluate the safety and effectiveness of insulin initiation with once-daily insulin detemir (IDet) or insulin glargine (IGlar) in real-life clinical practice in Turkish patients with type 2 diabetes mellitus (T2DM). Insulin detemir and insulin glargine are widely used as add-on therapies for patients not responding to oral anti-diabetic drug (OAD) regimens, but there are few studies directly comparing the two insulin analogues in routine care [4,5,6]. The primary objective of this international observational study, SOLVETM, was to evaluate the safety and effectiveness of once-daily insulin detemir or glargine in a real-life clinical setting in patients with T2DM failing OAD therapy. The following is a sub-analysis of the local SOLVETM cohort in Turkey, the first observational study comparing the effects of once-daily insulin detemir with insulin glargine initiation as add-on therapy to OAD in patients with T2DM
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