Home 2005.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 1:1
Participants	Inclusion criteria: T1DM and post‐prandial serum C‐peptide levels of < 0.50 nmol/L or < 1.50 µg/L when the capillary blood glucose level was ≥ 5.5 mmol/L (≥ 100 mg/dL) at the first visit. All had been treated with insulin for at least 1 year, aged 17–77 years Exclusion criteria: from FDA document (FDA 2000): pregnancy, surgical treatment for diabetic retinopathy, other glucose‐lowering drugs within 4 weeks, impaired renal function, abnormal liver tests Diagnostic criteria: C‐peptide < 0.05 nmol/L Number of study centres: 63
Interventions	Intervention(s): glargine Comparator(s): NPH Duration of intervention: 28 weeks Duration of follow‐up: 28 weeks Run‐in period: 4 weeks
Outcomes	Reported outcome(s) in full text of publication: glycaemic variables, adverse events, safety
Study registration	Trial identifier: HOE 901/3001 Study terminated early: no
Publication details	Language of publication: English Funding: commercial funding (Aventis Pharma) Publication status: peer‐reviewed journal and conference abstract
Stated aim of study	Quote: "To compare insulin glargine with NPH human insulin for basal insulin supply in adults with type 1 diabetes"
Notes	Of the 655 people entering the screening phase, 602 were randomised and 585 were treated with study medication ‐ 292 with insulin glargine and 293 with NPH insulin (147 people received once‐daily NPH insulin and 146 received twice‐daily NPH insulin) ‐ not reported how the 602 were randomised The corresponding author, Dr. Home, assumed that no participants died, as otherwise it would have been stated in the published paper. Dr. Home made us aware that the publication Witthaus et al. 2001 included the same population. No additional data from conference abstract Study included in FDA 2000 document (FDA 2000)‐ no additional outcome data