Novo Nordisk A/S.

AimTo confirm glycaemic control superiority of mealtime fast‐acting insulin aspart (faster aspart) in a basal–bolus (BB) regimen vs basal‐only insulin.Materials and methodsIn this open‐label, randomized, 18‐week trial (51 sites; 6 countries), adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c] ± SD: 7.9% ± 0.7% [63.1 ± 7.5 mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8‐week optimization of prior once‐daily basal insulin followed by randomization 1:1 to either a BB regimen with faster aspart (n = 116) or continuation of once‐daily basal insulin (n = 120), both with metformin. Primary endpoint was HbA1c change from baseline after 18 weeks of treatment. Secondary endpoints included: postprandial plasma glucose (PPG) change and overall PPG increment (all meals); weight; treatment‐emergent adverse events; hypoglycaemic episodes.Results HbA1c decreased from 7.9% (63.2 mmol/mol) to 6.8% (50.7 mmol/mol; BB group) and from 7.9% (63.2 mmol/mol) to 7.7% (60.7 mmol/mol; basal‐only group); estimated treatment difference [95% confidence interval] −0.94% [−1.17; −0.72]; −10.3 mmol/mol [−12.8; −7.8]; P < .0001. Reductions from baseline in overall mean 2‐hour PPG and overall PPG increment for all meals (self‐measured plasma glucose profiles) were statistically significant in favour of BB treatment (P < .0001). Severe/blood glucose confirmed hypoglycaemia rate (12.8 vs 2.0 episodes per patient‐years of exposure), total daily insulin (1.2 vs 0.6 U/kg) and weight gain (1.8 vs 0.2 kg) were greater with BB than with basal‐only treatment.ConclusionsIn T2D, faster aspart in a BB regimen provided superior glycaemic control as compared with basal‐only insulin, but with an increase in the frequency of hypoglycaemia and modest weight gain.

Aims: Weight gain upon insulin initiation is opposite to clinical goals in diabetes management. This trial aimed to determine the impact of modest dietary intervention on weight change and examine weight change in baseline body mass index strata when initiating once-daily insulin detemir (IDet) in overweight or obese insulin-naïve individuals with type 2 diabetes (T2D).Methods: DIET (Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes) was a 26-week, randomized, treat-totarget, stratified, controlled, open-label, multinational trial. Subjects were randomized 1 : 1 to either the IDet group, which received basic dietary and physical exercise advice at baseline, or the Diet+IDet group, which had additional dietary consultations with a certified dietician (three face-to-face meetings, three phone contacts).Results: Mean estimated change in body weight from baseline ± standard error (SE) was −1.05 ± 0.23 kg for Diet+IDet and −0.56 ± 0.23 kg for IDet alone. Estimated mean difference was 0.49 kg (95% confidence interval: −0.15; 1.13, p = 0.132). Glycaemic control, measured by haemoglobin A1c (HbA1c) and fasting plasma glucose, improved similarly in both groups. Both groups reported variable reductions in caloric intake and overall physical activity levels. No difference in hypoglycaemia rates between groups was observed. Conclusion:This study suggests that a modest dietary intervention plus basic lifestyle advice, compared with basic lifestyle advice alone, resulted in similar weight change, efficacy, safety and tolerability when initiating IDet once daily in overweight or obese insulin-naïve individuals with T2D.

In patients with T2DM with A1c 7-8%, who were previously treated by conventional LM and OAD therapy, adding glargine resulted in greater improvements in glycaemic control vs. intensifying LM.

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