| Methods |
DURATION OF INTERVENTION:
4 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
N/A.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Clinically diagnosed type 1 diabetes who had been receiving insulin therapy for 1 year with a basal‐bolus regimen of NPH insulin once daily at bedtime or twice daily in the morning and at bedtime plus regular human insulin before meals was used for at least 2 months.
EXCLUSION CRITERIA:
The presence of known proliferative diabetic retinopathy, impaired hepatic or renal function, and a history of hypoglycemia unawareness
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
42
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine 30 or glargine 80 (QD) + HI.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD) + RI
TREATMENT BEFORE STUDY:
A basal‐bolus regimen of NPH insulin once daily at bedtime (n = 177) or twice daily in the morning and at bedtime (n = 156) plus regular human insulin before meals was used for at least 2 months.
TITRATION PERIOD:
3 weeks. |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Fasting plasma glucose, HbA1C , fructosamine, FBG, mean of a seven‐point blood glucose profile, and nocturnal blood glucose at 0300, hypoglycemia, antibodies to insulin. |
| Notes |
STATED AIM OF STUDY:
To compare the 4‐week efficacy and safety of two formulations of HOE 901 with NPH insulin |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
