| Methods |
DURATION OF INTERVENTION:
16 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:
Men and women > 18 years old with type 1 diabetes for > 1 year who were already using a mealtime basal regimen for > 2 months, with basal insulin dose < 100 units/day, HbA1c < 12.0%, and BMI < 35.5 kg/m2.
EXCLUSION CRITERIA:
Proliferative retinopathy, recurrent major hypoglycemia, impaired hepatic or renal function, or uncontrolled cardiovascular problems, use of medication known to interfere with glucose metabolism, pregnant or breast‐feeding women.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
52
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (BID) + Aspart.
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (BID) + Aspart.
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
HbA1c, FPG, and prebreakfast self monitored plasma glucose, ten‐point self‐monitored plasma glucose profiles, total and nocturnal (2300 ‐0600) excursions in the CGMS profiles, hypoglycemia |
| Notes |
STATED AIM OF STUDY:
Investigate whether insulin detemir provides improved glycemic control compared with NPH insulin, regardless of administration time, when used in a mealtime‐basal treatment regimen. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
