| Methods |
DURATION OF INTERVENTION:
36 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:
Age between 18 and 75 years, type 1 diabetes on insulin for at least 6 months, body mass index less than 45, baseline HbA1c 6‐11%, and ability and willingness to perform self‐blood glucose monitoring.
EXCLUSION CRITERIA:
?
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
1
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Determir (QD) + Aspart
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (BID) + Aspart
TREATMENT BEFORE STUDY:
Twice‐daily or multiple dose insulin injections.
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
Glycosylated haemoglobin
SECONDARY OUTCOMES:
Frequency of reported severe hypoglycaemic episodes and overall frequency of both severe and non‐severe
hypoglycaemic events during the last 12 weeks of each treatment period. Other secondary endpoints were FPG,
weight, fasting lipids and questionnaire‐based patient satisfaction. Safety endpoints were adverse event recording and vital signs namely pulse and blood pressure. |
| Notes |
STATED AIM OF STUDY:
Combining insulin glargine and aspart in a basal bolus regimen |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
