Study designs of evaluations included in the review
Explicit inclusion criteria were not reported. Product-specific reviews without comparisons and general reviews of insulin analogues were excluded from the review.
Specific interventions included in the review
Studies that investigated the rapid-acting insulin analogue insulin aspart were eligible for inclusion. These could also include premixed formulations containing various ratios of soluble rapid-acting insulin aspart and protamine-crystalised intermediate-acting insulin aspart. The included studies stated that insulin aspart or biphasic insulin aspart, insulin aspart plus insulin detemir was used. The studies varied in their combination of soluble and protamine-bound insulin aspart use, the mode of presentation (including subcutaneous), the dose (up to three times daily), and administration before or after meals.
Participants included in the review
The review was restricted to studies with human participants; other than that no inclusion criteria were defined. The included studies enrolled patients with type 1 and/or type 2 diabetes mellitus, healthy volunteers, and/or those with diabetic ketoacidosis.
Outcomes assessed in the review
Studies were eligible for inclusion if they reported on the assessment of post-prandial glycaemia, glycosylated haemoglobin levels and the corresponding effect on major hypoglycaemia, the incidence of major and nocturnal hypoglycaemia, the assessment of convenience and flexibility of administration before and after a meal, and the safety and efficacy in pump use.
How were decisions on the relevance of primary studies made?
Two independent reviewers determined the relevance of publications.