| Methods |
DURATION OF INTERVENTION:
6 months
DURATION OF FOLLOW‐UP:
6 months
RUN‐IN PERIOD:
not stated
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
patients with type 2 diabetes mellitus from Helsinki University Hospital who took part in a phase III study
INCLUSION CRITERIA:
type 2 diabetes treated with diet and oral medication or diet alone; BMI >=25 kg/m2, age 35‐75 years; HbA1c >=7.5%, fasting serum glucose >=7.8mmol/L
EXCLUSION CRITERIA:
not stated
DIAGNOSTIC CRITERIA:
not stated
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
mainly antihypertensives (same before and after the study) |
| Interventions |
NUMBER OF STUDY CENTRES:
one
COUNTRY/ LOCATION:
Finland
SETTING:
outpatient clinics
INTERVENTION 1 (DOSE/DAY):
pioglitazone; 30 mg/day
Control 1 (DOSE/DAY):
glibenclamide; 2.5 mg/day
CONTROL 2 (DOSE/DAY):
placebo
TREATMENT BEFORE STUDY:
not stated
TITRATION:
clinics visited at 2‐6 week intervals for safety measurements; if the reduction in HbA1c at week 9 was not greater than or equal to 0.3%, antidiabetic medication was doubled in glibenclamide group (0 patients) and increased to 45 mg/day in the pioglitazone group (4 of 9 patients) |
| Outcomes |
PRIMARY OUTCOMES:
not stated (inflammatory markers)
SECONDARY OUTCOMES:
HbA1c, C‐peptide, serum insulin, lipids, free fatty acids, fasting serum glucose, adverse events |
| Notes |
AIM OF STUDY:
study of inflammatory factors in type 2 diabetes:
1.are inflammatory factors and activation of the complement system related?
2.how does improvement of glycaemic control by pioglitazone or glibenclamide affect concentrations of acute phase seroproteins?
3.is improved metabolic control related to changes in complement activation? |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
