Hanefeld 2007.
| Methods | DURATION OF INTERVENTION: 52 weeks DURATION OF FOLLOW‐UP: 52 weeks RUN‐IN PERIOD: eligible patients on oral antidiabetic medication stopped treatment 2 weeks before starting a 4‐week, single‐blind placebo run‐in period LANGUAGE OF PUBLICATION: English | |
| Participants | WHO PARTCIPATED: patients with type 2 diabetes INCLUSION CRITERIA: FPG = 7.0 ‐ 15.0 mmol/L C‐peptide >= 27 nmol/L; BMI = 22 ‐ 38 EXCLUSION CRITERIA: patients on insulin therapy or those with diabetic complications requiring treatment, heart failure NYHA III/IV, or serious renal, hepatic (liver function tests > 2.5 times the upper limit of normal). haematologic impairment or women of childbearing potential DIAGNOSTIC CRITERIA: see above CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated | |
| Interventions | NUMBER OF STUDY CENTRES:
71
COUNTRY/ LOCATION:
8 European countries
SETTING:
not stated
INTERVENTION (DOSE/DAY):
rosiglitazone as two equal daily doses (i.e. 2 mg bid or 4 mg bid) + placebo
CONTROL (DOSE/DAY):
glibenclamide once daily + placebo
TREATMENT BEFORE STUDY:
patients on monotherapy, combination therapy or diet and exercise only
TITRATION PERIOD:
over the first 12 weeks of treatment, the glibenclamide dose was titrated in 2.5 mg increments (final dose
range = 2.5 ‐ 15 mg) to achieve optimal glycaemic
control a double‐dummy system allowed ‘‘titration’’ of rosiglitazone without a change of dose concomitant medications with potential effects on glucose or lipid metabolism were kept at constant dose throughout the study |
|
| Outcomes | PRIMARY OUTCOMES: difference between rosiglitazone 8 mg/day and glibenclamide treatment groups with respect to change from baseline in HbA1c after 52 weeks of treatment SECONDARY OUTCOMES: (not stated) lipids, insulin resistance (HOMA), insulin, proinsulin, 32‐33 split proinsulin, safety, adverse effects | |
| Notes | AIM OF STUDY: to compare the efficacy, tolerability and safety of rosiglitazone with that of glibenclamide as monotherapy for patientswith type 2 diabetes over a 12‐month treatment period | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |