Farshchi 2016

Methods	Parallel randomised controlled trial, randomisation ratio 1:1
Participants	Inclusion criteria: participants with T2DM; age 25 to 65 years; HbA1c ≥ 8 % despite adequate therapy with lifestyle modification and one or two classes of OADs Exclusion criteria: alteration in insulin sensitivity such as major surgery, infection, renal failure (glomerular filtration rate < 50); glucocorticoid treatment; recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another); using any type of insulin; sight or hearing impaired; active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening; breast feeding, pregnancy or nursing, intention of becoming pregnant or not using adequate contraceptive measures; participating in another clinical study Diagnostic criteria: not reported
Interventions	Number of study centres: 1 Treatment before study: OADs Titration period: not reported
Outcomes	Outcomes reported in abstract of publication: HbA1c; FPG; PPG; hypoglycaemia (minor, major, nocturnal); weight gain; utility; cost‐effectiveness; costs (medical, non‐medical)
Reason for awaiting classification	Run‐in period: none Study terminated early: no Trial register ID:NCT01889095
Stated aim of study	Language of publication: English Funding: commercial (Novo Nordisk Pars, Iran) Publication status: full article in a peer reviewed journal
Trial identifier	Quote from publication: "The aim of the present piggyback study was to investigate the cost‐effectiveness of BIAsp 30, using the data from a clinical trial of Iranian patients with T2DM"
Notes	According to information available from ClinicalTrials.gov and Farshchi 2016, treatment goals were fasting BG between 80 and 120 mg/dL, postprandial BG less than 160 mg/dL, and HbA1c less than 7.0% in both comparison groups. However, the authors also mentioned an additional target for the pre‐dinner BG of less than 100 mg/dL for the NPH/Reg group. In addition, the authors report that BG targets for dose titration were based on pre‐meal targets alone and according to this information, dose titration started only at BG above 126 mg/dL. It thus remains unclear whether there was an additional BG target in the NPG/Reg group. We contacted the author for clarification and additional information but did not get an answer.