| Methods |
DURATION OF INTERVENTION:
16 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
1 to 4 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Eligible patients had type 1 diabetes, were 18‐80 years of age, and had been receiving treatment with NPH insulin for at least 1 year and insulin lispro for at least 3 months. Patients had to have a serum C‐peptide level < 9 mg/dl (0.5 mmol/L) in the presence of a blood glucose level _99.0 mg/dl (5.5 mmol/L) and a GHb value < 12.0%.
EXCLUSION CRITERIA:
Patients with hepatic or renal impairment, those who were pregnant or breast feeding, and those who had received treatment with any glucose‐lowering drug other than insulin within 4 weeks of the study.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
60.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + lispro
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID) + lispro
TREATMENT BEFORE STUDY:
NPH + lispro
TITRATION PERIOD: |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Glycosylated haemoglobin, FBG, FPG, hypoglycaemia. |
| Notes |
STATED AIM OF STUDY:
We compared the effects of insulin glargine once a day at bedtime and NPH insulin once or twice a day as basal insulin treatment for 16 weeks in patients with type 1 diabetes who were currently receiving NPH insulin for basal treatment and preprandial insulin lispro for postprandial glycemic control. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
