| Methods |
DURATION OF INTERVENTION:
6 months
DURATION OF FOLLOW‐UP:
6 months
RUN‐IN PERIOD:
none
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
patients with type 2 diabetes inadequately controlled on a maximized oral antihyperglycemic double regimen of glimepiride and metformin
INCLUSION CRITERIA:
not stated
EXCLUSION CRITERIA:
not stated
DIAGNOSTIC CRITERIA:
not stated
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
not stated |
| Interventions |
NUMBER OF STUDY CENTRES:
1
COUNTRY/ LOCATION:
USA
SETTING:
University of Alabama (Birmingham, Alabama, USA)
INTERVENTION (DOSE/DAY):
rosiglitazone 8 mg + metformin/sulfonylurea
(administered once daily)
CONTROL (DOSE/DAY):
insulin injection of 70130 mixed human insulin (administered once daily before supper) + metformin/sulfonylurea
TREATMENT BEFORE STUDY:
maximized oral antihyperglycemic double regimen of glimepiride and metformin
TITRATION PERIOD:
the dose of rosiglitazone was fixed, whereas the 70/30 insulin was started at 0.2 units/kg and adjusted to achieve a FPG level of <= 120 mgldl without occurrence of severe or frequent hypoglycaemia |
| Outcomes |
PRIMARY OUTCOMES:
not stated (pancreatic beta‐cell function)
SECONDARY OUTCOMES:
(not stated)
fasting glucose, serum insulin, proinsulin levels, intravenous glucose tolerance tests, glucagon stimulation test for C‐peptide, HOMA |
| Notes |
AIM OF STUDY:
to confirm that TZDs improve pancreatic beta‐cell function independent of the improvement in glycaemic control |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
