Fulcher 2005.

Study characteristics
Methods	Design: parallel‐group RCT; non‐inferiority design; randomisation ratio: 1:1
Participants	Inclusion criteria: T1DM, 18‐80 years, treated with insulin for 1 year or more, HbA1c 8% or more,  Additional from CSR: BMI < 35 kg/m2, Ability and willingness to perform frequent SMBG using a blood glucose meter and to perform continuous blood glucose measurements on numerous occasions  Exclusion criteria: nightshift workers, patients with known sensitivity to the study drug or related drugs, and patients with impaired hepatic function or any other clinically relevant physiological or psychological medical conditions were excluded, Additional from CSR: treatment with any blood glucose altering drugs other than insulin in the last 4 weeks before study entry e.g. corticosteroids; pregnancy, breastfeeding; treatment with any investigational drug in the last 2 months before study entry Diagnostic criteria:  post‐prandial C‐peptide level ≤ 0.5 nmol/L (≤ 1.5 ng/mL) in the presence of a blood glucose level ≥ 5.5 mmol/L Number of study centres: 9
Interventions	Intervention(s): glargine Comparator(s): NPH Duration of intervention: 30 weeks (6‐week forced titration phase + 24‐week phase) Duration of follow‐up: 30 weeks Run‐in period: — (but had a one‐ to two‐week screening phase before the treatment phase)
Outcomes	Reported outcome(s) in full text of publication: glycaemic control, hypoglycaemia, weight, lipid status, safety
Study registration	Trial identifier: HOE901/4010  Study terminated early: no
Publication details	Language of publication: English Funding: commercial funding (Aventis) Publication status: peer‐reviewed journal and conference abstract
Stated aim of study	Quote: "To compare glycaemic control and symptomatic hypoglycaemia rates with glargine versus neutral protamine Hagedorn (NPH) in poorly controlled type 1 diabetes patients."
Notes	Conference abstract added no additional information CSR was provided by Sanofi. CSR provided protocol,  diagnostic criteria for T1DM, additional outcome data (e.g. mortality, ketoacidosis, hypoglycaemia) and information on bias.