| Methods |
DURATION OF INTERVENTION:
6 months
DURATION OF FOLLOW‐UP:
6 months
RUN‐IN PERIOD:
3 months with dietary treatment only, at visit 6 weeks pre‐randomisation any patient having developed symptoms of uncontrolled diabetes or who had fasting plasma glucose of >13 mmol/L was withdrawn and commenced or recommenced on oral antihyperglycaemic agents
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
overweight, diet‐controlled patients with type 2 diabetes mellitus
INCLUSION CRITERIA:
type 2 diabetes, 45‐80 years; diet‐treated with an HbA1c <7.0% or low‐dose oral hypoglycaemic therapy with HbA1c <7.5%; BMI >27kg/m2; women of childbearing age had to be sterilised or use a reliable contraceptive
EXCLUSION CRITERIA:
diet‐treated with an HbA1c >10%; currently taking lipid‐lowering therapy; previously intolerant of any study medications; study medications would be contraindicated (alanine transaminase more than three times the upper limit of normal, serum creatinine >150 µmol/L, history of heart failure); recent myocardial infarction (<3 months); uncontrolled angina; uncontrolled hypertension
DIAGNOSTIC CRITERIA:
not stated
CO‐MORBIDITIES:
treated hypertension:
‐ intervention 40%;
‐ control 1 60%;
‐ control 2 65%;
‐ one current smoker in each group.
CO‐MEDICATIONS:
treated with aspirin:
‐ intervention 15%;
‐ control 1 30%;
‐ control 2 20%. |
| Interventions |
NUMBER OF STUDY CENTRES:
one
COUNTRY/ LOCATION:
UK
SETTING:
unclear
INTERVENTION 1 (DOSE/DAY):
pioglitazone; 30 mg once a day (up to 45 mg o.d.)
CONTROL 1 (DOSE/DAY):
metformin; 500 mg twice a day (up to 1g t.i.d)
CONTROL 2 (DOSE/DAY):
gliclazide; 80 mg once a day (up to 160 mg b.d.)
TREATMENT BEFORE STUDY:
12‐15 in each group previously on oral antihyperglycaemic agents; 8‐12 in each group treated hypertension; 3‐6 in each group treated with aspirin
TITRATION:
if fasting blood glucose remained >7 mmol/L treatment was uptitrated to a maximum of metformin 1g t.i.d., pioglitazone 45 mg o.d., or gliclazide 160 mg b.d. (for three months, then kept fixed for a further three months) |
| Outcomes |
PRIMARY OUTCOMES:
lipoprotein subfractions; sample size calculation based on triglycerides
SECONDARY OUTCOMES:
HbA1c, renal function, liver function, glucose, full blood count |
| Notes |
AIM OF STUDY:
to compare the effects of metformin, pioglitazone, and gliclazide on lipoprotein subfractions in overweight, diet‐controlled type 2 diabetic patients |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
