Methods |
DURATION OF INTERVENTION:
28 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
? weeks.
LANGUAGE OF PUBLICATION:
English. |
Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Type 1 diabetics with low post‐prandial C‐peptide levels.
EXCLUSION CRITERIA:
?
DIAGNOSTIC CRITERIA:
Not defined |
Interventions |
NUMBER OF STUDY CENTRES:
63.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + HI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID) + HI
TREATMENT BEFORE STUDY:
NPH, Ultralente
TITRATION PERIOD:
? |
Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin.
SECONDARY OUTCOMES:
Fasting plasma glucose, fasting blood glucose, nocturnal bloog glucose, hypoglycaemia. |
Notes |
STATED AIM OF THE HOME 2005 PUBLICATION:
To compare the effect of insulin glargine and NPH on overall blood glucose control and safety.
STATED AIM OF THE WITTHAUS 2001 PUBLICATION:
To evaluate the impact of
using insulin glargine on satisfaction with treatment and
psychological well‐being. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |