| Methods |
DURATION OF INTERVENTION:
26 weeks
DURATION OF FOLLOW‐UP:
26 weeks
RUN‐IN PERIOD:
‐ 6 ‐8 weeks single‐blind washout period, including 2 weeks for baseline measurements.
‐ patients who had never received pharmacological antidiabetic therapy were enrolled in the study and entered a 6‐week single‐blind run‐in period
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
78% white patients with type 2 diabetes mellitus
INCLUSION CRITERIA:
type 2 diabetes; HbA1c >= 7.0%, FPG >=140 mg/dl; fasting C‐peptide >1 ng/ml
EXCLUSION CRITERIA:
chronic insulin use; history of ketoacidosis; unstable or progressive diabetic retinopathy, nephropathy, neuropathy; impaired liver function; impaired kidney function; anaemia; within 6 months of the study: myocardial infarction, coronary angioplasty or bypass graft, unstable angina, transient ischaemic attacks, documented cerebrovascular accident
DIAGNOSTIC CRITERIA:
HbA1c >= 7.0%, FPG >=140 mg/dl; fasting C‐peptide >1 ng/ml
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
not stated |
| Interventions |
NUMBER OF STUDY CENTRES:
35
COUNTRY/ LOCATION:
all regions of the USA
SETTING:
unclear; investigators consisted of board‐certified endocrinologists and primary care physicians in academic and nonacademic sites
INTERVENTION (DOSE/DAY):
pioglitazone 7.5, 15, 30, 45 mg/day (four groups)
CONTROL (DOSE/DAY):
placebo
TREATMENT BEFORE STUDY:
‐ most commonly sulphonylureas (glyburide and gliclazide), 13% had received 2 or more antidiabetic medications.
‐ discontinuation of prior antidiabetic medication at the beginning of the washout period (i.e. 8 weeks before receiving double‐blind treatment).
no required modifications of current dietary regimens during the study |
| Outcomes |
PRIMARY OUTCOMES:
not stated (HbA1c)
SECONDARY OUTCOMES:
lipid parameters, FPG, safety assessment and adverse effects |
| Notes |
AIM OF STUDY:
to assess the metabolic effects of 4 doses of pioglitazone monotherapy in the treatment of patients with type 2 diabetes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
