| Methods |
DURATION OF INTERVENTION:
30 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
2 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Patients with type 1 diabetes, aged 18‐80 years, who were treated with insulin for at least 1 year and who had inadequate glycaemic control (HbA1c ?8%)
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.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
9
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + lispro.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD)+lispro
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
6 weeks. |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin.
SECONDARY OUTCOMES:
Mean and variability of FBG, response rates for FBG and HbA1c, the incidence and rate of hypoglycaemia, weight change and lipid profiles. |
| Notes |
STATED AIM OF STUDY:
To compare the effects of glargine and NPH, when administered once daily at bedtime in a
'treat‐to‐target', basal‐bolus regimen with lispro (administered three‐times daily before meals), on metabolic control in patients with suboptimally controlled type 1 diabetes (HbA1c ?8%). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
