| Methods |
DURATION OF INTERVENTION:
28 weeks.
DURATION OF FOLLOW‐UP:
N/A
RUN‐IN PERIOD:
1 to 4 weeks.
LANGUAGE OF PUBLICATION:
English. |
| Participants |
WHO PARTCIPATED:
Type 1 diabetic adult patients.
INCLUSION CRITERIA:
Men and women 18‐80 years of age with type 1 diabetes (postprandial C‐peptide levels of _0.5 nmol/L) for at least 1 year and GHb levels of <12.0% were eligible.
EXCLUSION CRITERIA:
Treatment with antidiabetic drugs other than insulin within 1 month of study entry, pregnancy, impaired hepatic function, and impaired renal function. Patients could not work a night shift.
DIAGNOSTIC CRITERIA:
Not defined |
| Interventions |
NUMBER OF STUDY CENTRES:
49.
SETTING:
Out‐patient.
INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
Glargine (QD) + RI
CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY):
NPH (QD/BID)+RI
TREATMENT BEFORE STUDY:
?
TITRATION PERIOD:
? |
| Outcomes |
PRIMARY OUTCOME(S):
?
SECONDARY OUTCOMES:
Mean changes from baseline of GHb and capillary FBG levels, median change from baseline of FPG levels, incidence of hypoglycemia, and incidence of hypoglycemia with a blood glucose level of < 2.0 mmol/L. |
| Notes |
STATED AIM OF STUDY:
Safety and efficacy of once‐daily insulin glargine versus once‐ or twice‐daily NPH insulin as part of basal‐bolus insulin regimens for patients with type 1 diabetes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
