| Methods |
Study design: open‐label parallel RCT
Study time frame: not reported
Duration of follow‐up: 24 weeks
|
| Participants |
Country: Japan
Setting: single centre
Inclusion criteria: HD patients with type 2 DM; poor glycaemic control (HbA1c ≥ 6.5% (48 mmol/mol) after 8 weeks on oral voglibose therapy of 0.9 mg daily
Number: treatment group (18); control group (18)
Mean age ± SD (years): treatment group (67.0 ± 9.2). control group (66.0 ± 9.0)
Sex (M/F): treatment group (11/7); control group (11/7)
Exclusion criteria: deranged liver function at baseline; decompensated congestive heart failure; infectious disease; thyroid disease; malignant tumour; treatment with steroids
|
| Interventions |
Treatment group
Oral mitiglinide: started with 5 mg 3 times/d before each meal. This dose was increased up to 10 mg 3 times/d if target HbA1c values < 6.5% (48 mmol were not reached after 12 weeks). Elderly HD patients (> 75 years) initially received 2.5 mg 3 times/d. The dose was escalated to 5 mg 3 times/d at week 12, if necessary. Voglibose: dose was reduced from 0.9 to 0.6 mg/d if necessary to avoid hypoglycaemia. On the other hand, if the physician judged that mitiglinide 5 mg 3 times/d presented a safety problem, its dose could be reduced to 2.5 mg 3 times/d or 2.5 mg 2 times/d in elderly patients. Treated for 24 weeks
Control group
|
| Outcomes |
HbA1c, GA and plasma glucose levels were measured as the criteria for glycaemic control
Insulin resistance was assessed using HOMA‐IR
Plasma insulin
Levels of Hb, total bilirubin, AST, ALT, lactate dehydrogenase, alkaline phosphatase, g‐GTP, total cholesterol, HDL and triglycerides
Body weight before and after dialysis
BMI
CTR determined by radiographic examination of the chest
Predialysis SBP and DBP
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A computer‐generated list was used for randomisation. |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open‐label study |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No patients dropped out in either arm |
| Selective reporting (reporting bias) |
Unclear risk |
The prespecified outcomes were not available on a clinical trials database |
| Other bias |
Low risk |
No conflicts of interest |