| Methods |
DURATION OF INTERVENTION:
6 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:
Had received once‐daily (evening) NPH in combination with meal‐related human soluble insulin
(HSI) for at least 6 months and had documented type 1 diabetes for > 2 years.
EXCLUSION CRITERIA:
Patients with proliferative retinopathy; impaired hepatic function (aspartate aminotransferase and/or alkaline phosphatase at least twice the upper normal level); impaired renal function (creatinine > 150 µmol/L); decompensated heart failure; unstable angina pectoris; myocardial infarction within the last year; hypertension (systolic and/or diastolic blood pressure > 180 and 100 mmHg, respectively); hypoglycemic unawareness; recurrent major hypoglycemia; or allergy to insulin or any compositional component, as well as those who abused alcohol or narcotics; used systemic corticosteroids, _‐blockers, or hormones within the past month; or were pregnant, breast‐feeding, or using inadequate contraceptive measures. Patients treated with other investigational products within the last 3 months or previously treated with insulin detemir were also excluded.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
7
SETTING:
Out‐patient+inpatient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Detemir (QD)+ HI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD) + HI
TREATMENT BEFORE STUDY:
NPH + HI
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
Area under the serum glucose curve
in the time interval from 23:00 to 08:00.
SECONDARY OUTCOMES:
mean serum glucose profiles, eight‐point blood glucose profiles, mean levels of home‐monitored fasting blood glucose, mean fructosamine level, insulin doses, hypoglycaemic episodes. |
| Notes |
STATED AIM OF STUDY:
Compare the blood glucose‐lowering effect of insulin detemir with that of NPH in terms of metabolic
control, intrasubject variation in fasting blood glucose, dose requirement, and safety in type 1 diabetic patients treated with basal‐bolus therapy. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
