Research in context
Evidence before this study
We systematically searched the PubMed, EMBASE, and Web of Science electronic databases for articles published between January, 2000, and July, 2016, using a combination of search terms including “inpatient” OR “hospital”, “diabetes/exp” OR “diabetes”, and “clinical trial/de” OR “randomized controlled trial/de”. We excluded reviews and observational studies. Additionally, we reviewed current clinical trial registrations on ClinicalTrials.gov and EudraCT. We supplemented the search by reviewing the reference lists of relevant publications.
The search yielded 212 results from PubMed (68), Embase (70), and Web of Science (74). There were 155 results after removal of duplicates, and we identified 41 interventions to improve glycaemic control in patients admitted to hospital. We previously reported a small feasibility study (n=90) of a dipeptidyl peptidase-4 (DPP-4) inhibitor in patients with type 2 diabetes admitted to hospital who were treated with oral drugs and a low dose of insulin (<0·4 U/kg per day). In this pilot study we reported that treatment with sitagliptin plus correction doses of rapid-acting insulin before meals was effective in improving glycaemic control in patients with mild hyperglycaemia (blood glucose concentration <10 mmol/L); however, it was not as effective in patients whose blood glucose concentrations were higher than 10 mmol/L.
Added value of this study
Our study is the first large randomised trial investigating whether the use of a non-insulin drug (a DPP-4 inhibitor) in combination with basal insulin is a safe and effective alternative to the more labour-intensive basal–bolus insulin regimen.
Implications of all the available evidence
Guidelines from professional organisations for the management of non-critically ill patients with type 2 diabetes admitted to hospital recommend the use of basal–bolus insulin regimens, which are labour-intensive and associated with a risk of hypoglycaemia. The results of our clinical trial show that treatment with the DPP-4 inhibitor sitagliptin and basal insulin once daily is similarly efficacious and safe compared to multidose regimens with basal insulin once daily and rapid-acting insulin before meals in patients in hospital with uncontrolled glucose concentrations. Moreover, treatment with sitagliptin plus basal insulin was associated with lower daily insulin requirements and fewer insulin injections.