| Methods |
DURATION OF INTERVENTION:
16 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
4 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
The people recruited were men and women aged 18‐65 years with Type 1 diabetes and no previous experience of insulin glargine, who had been using a multiple insulin injection regimen for at least 1 year and who had a random C‐peptide ? 0.10 nmol/L and HbA1c 7.0‐9.5%. Women of childbearing potential were required to be using adequate contraception.
EXCLUSION CRITERIA:
People with proliferative retinopathy, recurrent severe hypoglycaemia, impaired hepatic or renal function, or who worked night shifts were excluded from the trial
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
5
SETTING:
Out‐patient+inpatient
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + Lispro
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID)+HI
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
4 weeks |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin
SECONDARY OUTCOMES:
insulin doses, pre‐breakfast SMBG concentration, 24‐h eightpoint SMBG levels, 24‐h inpatient plasma glucose levels, and monthly rate of hypoglycaemia |
| Notes |
STATED AIM OF STUDY:
The aim of the present study was to compare blood glucose control in people with Type 1 diabetes managed with a multiple insulin injection regimen and strict glycaemic targets using insulin glargine plus insulin lispro in combination, and NPH insulin plus unmodified human insulin. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
