Yamanouchi 2005.
| Methods | DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 12 months RUN‐IN PERIOD: one month for baseline measurements LANGUAGE OF PUBLICATION: English | |
| Participants | WHO PARTCIPATED: drug‐naive Japanese patients with a short duration of type 2 diabetes mellitus INCLUSION CRITERIA: patients continued in the study if they met the inclusion criteria of HbA1c >= 7.0% and FPG >= 7.78 mmol/ l, at the end of the 1‐month observation period; all patients had a body mass index (BMI) between 22 and 35 kg/m2 (mean 25.9 kg/m2); the criteria for obesity in Japanese people are BMI = 25 kg/m2 EXCLUSION CRITERIA: patients who had unstable or rapidly progressive diabetic retinopathy, nephropathy, or neuropathy; patients with liver dysfunction (AST, ALT > 1.5× upper limit of normal); impaired kidney function (serum creatinine > 133µmol/l), or anaemia; patients with a myocardial infarction, angina, congestive heart failure, or a documented cerebrovascular accident DIAGNOSTIC CRITERIA: not stated CO‐MORBIDITIES: not stated CO‐MEDICATIONS: ‐ antihypertensive drugs or other concurrent treatments, including dietary regimens, remained unchanged throughout the study; ‐ the number of patients taking antihypertensive medications were 16 (42%), 18 (46%) and 18 (49%) (for the pioglitazone, metformin and glimepiride groups, respectively); ‐ none of the participiants was on lipid‐lowering therapy. | |
| Interventions | NUMBER OF STUDY CENTRES: not stated COUNTRY/ LOCATION: Japan SETTING: unclear INTERVENTION 1 (DOSE/DAY): pioglitazone; 30‐45 mg/day CONTROL 1 (DOSE/DAY): metformin; 750 mg/day CONTROL 2 (DOSE/DAY): glimepiride; 1.0‐2.0 mg/day TREATMENT BEFORE STUDY: ‐ no patient had ever received an oral hypoglycaemic agent or a lipid drug; ‐ all patients were treated with diet and exercise alone for at least 3 months, including the 1 month for baseline measurements before the study (observation period). | |
| Outcomes | PRIMARY OUTCOMES: HbA1c SECONDARY OUTCOMES: FPG, 1,5‐anhydroglucitol, plasma insulin, haematology, biochemistry, adverse events, BMI, blood pressure, lipids, free fatt acids | |
| Notes | AIM OF STUDY: to compare changes in major metabolites for 12 months when TZD, biguanide, or glimepiride were used in drug‐naive Japanese patients with type 2 diabetes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |
ACE = ; ADA = American Diabetes Association; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ATII or AT2 = ; b.d. = bis in die, twice daily; BMI = body mass index (kg(m2); BP = blood pressure; CRP = C‐reactive protein; CVD = cardiovascular disease; FPG = fasting plasma glucose; HbA1c = glycosylated haemoglobin A1c; HOMA = homeostasis model assessment (of insulin sensitvity); NYHA = New York Heart Association; OAM = oral antidiabetic medication; o.d. = once daily; PPAR = peroxisome proliferator activated receptor; q.d. = quaque die, once a day; QUICKI = quantitative insulin sensitivity check index; SU = sulfonylureas; t.i.d. = ter in die, three times daily; TZD = thiazolidinediones ("glitazones"); WHO = World Health Organisation