| Methods |
DURATION OF INTERVENTION:
32 weeks
DURATION OF FOLLOW‐UP:
32 weeks
RUN‐IN PERIOD:
single‐blind run‐in phase (3‐5 weeks), one placebo tablet and three placebo capsules
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
pharmaco‐naive patients with type 2 diabetes mellitus
INCLUSION CRITERIA:
patients with recently diagnosed type 2 diabetes (<12 months), defined by WHO criteria, HbA1c 7.5‐11.0%; >=40 years
EXCLUSION CRITERIA:
history of lactic acidosis, liver disease, NYHA cardiac status class III or IV congestive heart failure, HIV infection, renal transplant, impaired kidney function, impaired liver function (defined), BMI below 20 kg/m2 or above 40 kg/m2, breastfeeding, pregnant, or of childbearing potential, participation in any clinical trial that included any drugs; undergoing therapy with nicotinic acid, renal dialysis or cancer therapy; anaemia; systemic glucocorticoid therapy or use of OAM, ACE inhibitors, or angiotensin II receptor agonists within 30 days; known allergy to metformin or any TZD drug
DIAGNOSTIC CRITERIA:
WHO 1999
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
not stated |
| Interventions |
NUMBER OF STUDY CENTRES:
19
COUNTRY/ LOCATION:
Russia (4 sites), Hungary (15 sites)
SETTING:
unclear
INTERVENTION (DOSE/DAY):
pioglitazone; 30 mg/day, titrated to max of 45 mg/day, mean dose 41.5 mg/day
CONTROL (DOSE/DAY):
metformin; 850 mg/day, titrated to max of 2550 mg/day, mean dose 2292 mg/day
TREATMENT BEFORE STUDY:
patients received diabetes education and individualised dietary and physical activity instructions (run‐in)
TITRATION:
‐ intervention: after randomisation, one 30 mg pioglitazone capsule and 3 placebo tablets daily, after 8 weeks, if FGP >= 7mmol/L, pioglitazone increased to 45mg capsule (+3 placebo tablets) (77% of group);
‐ control: after randomisation, one placebo capsule, one 850mg metformin tablet, 2 placebo tablets identical to metformin tablet daily; then 2 weeks post‐randomisation dose increased to two 850mg tablets (1700mg) +1 placebo tablet +1 placebo capsule; after 8 weeks, if FGP >=7mmol/L, metformin increased to three 850mg tablets (2550mg) +1 placebo capsule (73% of group). |
| Outcomes |
PRIMARY OUTCOMES:
change in HbA1c
SECONDARY OUTCOMES:
insulin sensitivity (HOMA‐S), lipoproteins, safety (BP, heart rate, weight, routine blood laboratory parameters, adverse events |
| Notes |
AIM OF STUDY:
to compare the efficacy and tolerability of monotherapy with pioglitazone to metformin in recently diagnosed type 2 diabetes patients (naive to oral antihyperglycaemic medication).
the primary objective was to compare the effect of each treatment on glycaemic control (change in HbA1c) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
