Design

Randomised {allocation concealed*}†, unblinded,* controlled trial with 12 weeks of follow up.

Patients

{72 patients}‡ who were 18 to 55 years of age and were following a stable insulin administration schedule of 2 to 3 daily injections for ≥ 2 months. Other inclusion criteria were screening and pre-randomisation glycated haemoglobin values between 7.0% and 11.9%, fasting plasma C peptide concentration ≤ 0.2 pmol/ml, body weight 80% to 130% of ideal, non-smoking for ≥ 6 months, normal results on chest x ray and pulmonary function tests, and normal sinus rhythm (rate 50 to 100 beats/min). 69 patients (96%) (mean age 37 y, 54% men, 80% white) were considered for analysis.