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. 2018 Sep 24;2018(9):CD011798. doi: 10.1002/14651858.CD011798.pub2

Abe 2010.

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
  • Voglibose: 0.9 mg/d for 24 weeks

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
  • Funding source: "The author states that Kissei Pharmaceutical had no involvement the preparation/approval of the paper. However, Kissei Pharmaceutical have paid for the FastTrack prioritization of the manuscript and they are the developers of mitiglinide."

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