Initiation of once daily insulin detemir is not associated with weight gain in patients with type 2 diabetes mellitus: results from an observational study

Jean-François Yale, Taner Damci, Marcel Kaiser, Eddy Karnieli, Kamlesh Khunti, Andreas Liebl, Florian Mm Baeres, Anne Louise Svendsen, Stuart A Ross, SOLVE Study Group, Jean-François Yale, Taner Damci, Marcel Kaiser, Eddy Karnieli, Kamlesh Khunti, Andreas Liebl, Florian Mm Baeres, Anne Louise Svendsen, Stuart A Ross, SOLVE Study Group

Abstract

Background: Obesity is common in type 2 diabetes (T2DM) and is associated with increased risk of morbidity and all-cause mortality. This analysis describes weight changes associated with insulin detemir initiation in real-life clinical practice.

Methods: Study of Once-Daily Levemir (SOLVE) was a 24-week international observational study of once-daily insulin detemir as add-on therapy in patients with T2DM receiving oral hypoglycaemic agents (OHAs).

Results: 17,374 participants were included in the analysis: mean age 62 ± 12 years; weight 80.8 ± 17.6 kg; body mass index (BMI) 29.2 ± 5.3 kg/m2; diabetes duration 10 ± 7 years; HbA1c 8.9 ± 1.6%. HbA1c decreased by 1.3 ± 1.5% during the study, with insulin doses of 0.27 ± 0.17 IU/kg. Patients with higher BMI had higher pre-insulin HbA1c, and similar reductions in HbA1c with insulin therapy. Weight decreased from 80.8 ± 17.6 kg to 80.3 ± 17.0 kg (change of -0.6 [95% CI -0.65; -0.47] kg), with 35% of patients losing >1 kg. Patients with the highest pre-insulin BMI lost the greatest amount of weight: BMI < 25: +0.8 [95% CI: 0.6; 0.9] kg, 25 ≤ BMI < 30: -0.2 [95% CI: -0.3; -0.8] kg, 30 ≤ BMI < 35: -1.0 [95% CI: -1.1; -0.8] kg; BMI ≥ 35: -1.9 [95% CI: -2.2; -1.6] kg. Minor hypoglycaemia decreased with increasing BMI: 2.3 and 1.3 events per patient year for BMI <25 and ≥ 35, respectively.

Conclusions: Overall, patients with poorly controlled T2DM achieved significant reductions in HbA1c after initiation of once-daily insulin detemir therapy, without weight gain. The favourable impact of insulin detemir on weight may not apply to other insulin preparations.

Trial registrations: ClinicalTrials.gov, NCT00825643 and NCT00740519.

Figures

Figure 1
Figure 1
Insulin dose in units and units per kilogram at final visit by BMI subgroup.
Figure 2
Figure 2
Demographic and treatment parameters associated with weight loss ≥ 1 kg by final visit – results of a final backward elimination logistic regression model. Error bars indicate 95% confidence intervals.

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Source: PubMed

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