Soliman 2013

Methods	Study design: open‐label RCT Study duration: date of first recruitment to last follow‐up not documented Study follow‐up period: 12 weeks
Participants	Country: Egypt Setting: University Hospital in Cairo Inclusion criteria: NODAT defined by BGL > 11.1 after an oral glucose tolerance test; stable graft function for more than 6 months after transplant Number (randomised/analysed): treatment group (31/28); control group (31/17) Mean age, range: 38.5, 31 to 62 years Sex: (M/F): 26/19 Exclusion criteria: prior history of T1DM or T2DM; BMI > 40; pregnancy; severe kidney impairment (GFR < 30 mL/min/1.73 m2); severe liver impairment; severe blood glucose elevation (HbA1c > 8.5%)
Interventions	Treatment group Oral sitagliptin: 100 mg but adjusted according to participant's eGFR eGFR > 50 50 mL/min/1.73 m2: 100 mg/d GFR 25 to 49 50 mL/min/1.73 m2: 50 mg/d Control group Glargine injection SC Dosages adjusted according to SC sliding scale pattern, titrated to target a fasting BGL ≤ 5.5 mmol/L Baseline immunosuppression Triple therapy of TAC or CSA, MMF or AZA, and prednisolone Co‐interventions All participants received metformin Glycaemic targets were pre‐prandial plasma glucose 5 to 7.2 mmol/L and HbA1c < 7%
Outcomes	Primary outcomes Transplant or graft survival: not reported HbA1c FBG Kidney function markers including creatinine, eGFR, albuminuria: not reported Systolic and diastolic BP: not reported Lipids (HDL, LDL, triglyceride) Body weight Secondary outcomes All‐cause mortality: not reported Macrovascular events (cardiovascular death, non‐fatal MI, non‐fatal stroke): not reported Microvascular events (new or worsening kidney disease, or retinopathy): not reported Safety/adverse events (including hypoglycaemia)
Notes	Multiple errors in publication especially for the tables, with errors in calculations Conflict of interest: no conflicts of interest were reported Contact with authors: corresponding author contacted due to contradictions in the results reported in the table compared to the text, but clarification and data required were not supplied by the time the review was finalised
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study described as randomised, method of randomisation was not reported
Allocation concealment (selection bias)	High risk	Allocation concealment not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Open‐label study but many endpoints requiring assay were performed by technicians blinded to the treatment sequence. Therefore most efficacy outcomes were blinded except for weight. For safety outcomes, it was unclear if researchers were blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	17/62 (27.4%) participants dropped out. Rates were higher in the glargine group (insulin) (14/31; 45%) compared with sitagliptin (3/31; 9.68%) In the insulin group 6 patients who required multiple short acting dosages of insulin were excluded; 3 were lost to follow‐up, and 5 did not want to continue insulin due to the fear of the long‐term need for insulin. In the sitagliptin group, all drop outs occurred 1 week after randomisation. 3/31 patients needed multiple short acting dosages of insulin and were excluded A PP analysis was conducted
Selective reporting (reporting bias)	Low risk	Prespecified primary outcomes of interest were reported
Other bias	Low risk	Funding source: no grants were received for the study