Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial.

AIMS: To evaluate the efficacy and safety of two insulin intensification strategies for patients with type 2 diabetes previously treated with basal insulin--insulin degludec (IDeg) and insulin aspart (IAsp)--administered as a co-formulation (IDegAsp) or as a basal-bolus regimen (IDeg and IAsp in separate injections). METHODS: This 26-week, open-label, treat-to-target, phase IIIb, non-inferiority trial randomized patients (1 : 1) to IDegAsp twice daily with main meals (n = 138; IDegAsp group) or IDeg once daily and IAsp 2-4 times daily (n = 136; IDeg+IAsp group). RESULTS: After 26 weeks, the mean glycated haemoglobin (HbA1c) level was 7.0% (53 mmol/mol) for the IDegAsp group and 6.8% (51 mmol/mol) for the IDeg+IAsp group (Δ%HbA1c from baseline -1.31 and -1.50%, respectively). The non-inferiority of IDegAsp versus IDeg+IAsp was not confirmed for mean change in HbA1c [estimated treatment difference (ETD) 0.18, 95% confidence interval (CI) -0.04, 0.41; p = non-significant]. No significant differences were observed in the proportion of patients achieving HbA1c <7.0% (56.5 and 59.6%, respectively). IDegAsp treatment resulted in a significantly lower total daily insulin dose, a smaller change in body weight, numerically lower rates of confirmed hypoglycaemia (self-reported plasma glucose <3.1 mmol/l; rate ratio 0.81; p = non-significant), and nocturnal confirmed hypoglycaemic episodes (rate ratio 0.80; p = non-significant) versus IDeg+IAsp. Patient-reported outcome scores for social functioning were significantly higher for IDegAsp versus IDeg+IAsp (ETD 2.2; 95% CI 0.3, 4.1; p < 0.05). CONCLUSIONS: Both intensification strategies effectively improved glycaemic control. Although non-inferiority was not confirmed, there were no significant differences between the groups that could affect clinical utility.

Increasing inequality in ischaemic heart disease morbidity among employed men in Denmark 1981-1993: the need for a new preventive policy.

BACKGROUND: In the mid 1980s European governments committed themselves to the WHO goal 'reduced inequality in health by year 2000' according to which inequality in health should be reduced by 25% by the year 2000. The study aim is to estimate the time trend in relative risk due to ischaemic heart disease (IHD) morbidity in employment status groups in Denmark in the period from 1981 to 1993 and to recommend a strategy to reduce inequality in health. MATERIAL AND METHODS: The study dealt with change in relative risk of IHD in main employment status AND groups as measured in three successive cohorts. The cohorts were defined as all METHODS: gainfully employed men in Denmark as of 1 January 1981, 1986 and 1991, respectively. Information on employment was retrieved for the three previous years. The cohorts were followed for first admissions with IHD as the principal cause during 5, 5, and 3 years respectively. RESULTS: Managers and white collar workers had an average or low and decreasing relative risk while male blue collar workers had a high and increasing relative risk. Thus the social inequality in IHD is rapidly increasing. Some occupational groups are known to be at high risk. Some of these high-risk groups, such as bus drivers, even have an increasing relative risk. CONCLUSIONS: The general health education has been successful in the prevention of IHD in the high-status groups but has failed to reduce the risk among blue collar workers. Preventive measures against IHD should focus on occupational groups at high, increasing risk and the measures should tailor to their 'subculture.'