| Methods |
DURATION OF INTERVENTION:
52 weeks
DURATION OF FOLLOW‐UP:
52 weeks
RUN‐IN PERIOD:
1‐3 weeks, patients received diaries for recording self‐monitored blood glucose and hypoglycaemic events; diabetes education and diet and exercise instructions; patients currently on anthyperglycaemic monotherapy continued this until day 1 of titration period
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
Mexican patients with type 2 diabetes mellitus
INCLUSION CRITERIA:
type 2 diabetes, HbA1c >7.5 to <=11% in patients not receiving oral antihyperglycaemic agent monotherapy, and >7.5 to <=9.5% in patients receiving oral antihyperglycaemic agent monotherapy; eligible patients must have undergone an adequate trial of dietary and lifestyle interventions before enrollment
EXCLUSION CRITERIA:
treatment with TZD or insulin within previous 3 months; current prescription of maximum dose of oral antihyperglycaemic agent or for combination therapy; treatment with systemic glucocorticoids (incl. topical and inhaled) within previous 30 days; cardiac disease with substantial limitation of functional capacity (NYHA class III or IV); serum triglycerides >400mg/dl, serum creatinine >2.0mg/dl, renal transplantation or current renal dialysis; ALT or AST >2.5 times upper limit of normal; clinical signs or symptoms of liver disease; haemoglobin <105 g/L for women or <115 g/L for men; previous HIV infection, signs and symptoms of substance abuse
DIAGNOSTIC CRITERIA:
not stated
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
‐ intervention: antilipidaemic agents (fibrates, statins, or both) 12.4%;
‐ control: antilipidaemic agents (fibrates, statins, or both) 11.4%. |
| Interventions |
NUMBER OF STUDY CENTRES:
19
COUNTRY/ LOCATION:
Mexico
SETTING:
unclear
INTERVENTION (DOSE/DAY):
pioglitazone; 15 mg up to 45 mg q.d.; mean final dose 37 mg q.d.
CONTROL (DOSE/DAY):
glimepiride; 2 mg up to 8 mg q.d., mean final dose 6 mg q.d.
TREATMENT BEFORE STUDY:
‐ intervention: 76% receiving oral antihyperglycaemic agent (52.1% secretagogues, 22.3% metformin), antilipidaemic agents (fibrates, statins, or both) 12.4%;
‐ control: 77.2% receiving oral antihyperglycaemic agent (57.7% secretagogues, 19.5% metformin), antilipidaemic agents (fibrates, statins, or both) 11.4%;
‐ all patients received diabetes education and diet and exercise instructions.
TITRATION:
12 weeks, initial dose pioglitazone 15 mg q.d. and glimepiride 2 mg q.d.; goal of titration to achieve FPG <=7 mmol/l and 1h postprandial blood glucose <=10 mmol/l; if FPG or post‐prandial blood glucose concentrations were consistently higher than glycaemic target, dose adjustments were made at 4 week intervals (through week 12 of titration period); pioglitazone: 15mg increments up to max of 45 mg q.d.; glimepiride 2mg increments up to max of 8 mg q.d.; investigators encouraged to keep doses constant thereafter |
| Outcomes |
PRIMARY OUTCOMES:
insulin sensitivity (HOMA, QUICKI, fasting insulin concentrations)
SECONDARY OUTCOMES:
HbA1c; lipids, lipoproteins, adverse events |
| Notes |
AIM OF STUDY:
to compare the effectiveness of 52 weeks treatment with pioglitazone and glimepiride in providing long term glycaemic control and increasing insulin sensitivity in Mexican patients with type 2 diabetes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
