Supplementary Table 3.
Risk of bias assessment table
| Del Prato 2021 | Risk Of Bias | Author Judgement |
|---|---|---|
| Random Sequence Generation (Selection Bias) | Low Risk | Open-label, parallel-group, phase 3 randomized controlled study |
| Allocation Concealment (Selection Bias) | Low Risk | Participants were randomly assigned (1:1:1:3), by the Eli Lilly and Company computer-generated random sequence using an interactive web response system to receive tirzepatide or glargine. |
| Blinding Of Participants & Personal (Performance Bias) | High Risk | Open labelled study |
| Blinding Of Outcome Assessment (Detection Bias) | High Risk | Open labelled study |
| Incomplete Outcome Data (Attrition Bias) | Low Risk | 1335 patients were randomized to receive either tirzepatide 10mg/d or glargine insulin, of which 1194 patients completed the study. Hence attrition was 114 patients (10.56%) |
| Selective Reporting (Reporting Bias) | Low Risk | All pre-specified outcomes were reported |
| Other Biases | High Risk | The study was funded by Eli Lilly and Company. |
| Frias 2018 | Risk Of Bias | Author Judgement |
| Random Sequence Generation (Selection Bias) | Low Risk | Randomized double blinded active control, parallel group study |
| Allocation Concealment (Selection Bias) | Low Risk | Stratified block randomization was done |
| Blinding Of Participants & Personal (Performance Bias) | Low Risk | Yes, double blinded RCT |
| Blinding Of Outcome Assessment (Detection Bias) | Low Risk | Yes, double blinded RCT |
| Incomplete Outcome Data (Attrition Bias) | Low RIsk | 318 patients were randomized, of which data from 283 patients were analysed after 26 weeks follow-up (attrition rate 11%). An attrition rate of more than 15% was considered to be significant |
| Selective Reporting (Reporting Bias) | Low Risk | All pre-specified outcomes were reported |
| Other Biases | High Risk | The study was funded by Eli Lilly and company |
| Frias 2020 | Risk Of Bias | Author Judgement |
| Random Sequence Generation (Selection Bias) | Low Risk | Randomized, double-blind, multicentre, parallel group, active trial |
| Allocation Concealment (Selection Bias) | Low Risk | Stratified block randomization was done |
| Blinding Of Participants & Personel (Performance Bias) | Low Risk | Double blind RCT |
| Blinding Of Outcome Assessment (Detection Bias) | Low Risk | Double blind RCT |
| Incomplete Outcome Data (Attrition Bias) | Low Risk | 111 patients were randomized, of which 95 patients completed the study. Hence attrition rate was 14.41% |
| Selective Reporting (Reporting Bias) | Low Risk | All Pre-Specified Outcomes Were Reported |
| Other Biases | High Risk | The study was funded by Eli Lilly and company. |
| Frias 2021 | Risk Of Bias | Author Judgement |
| Random Sequence Generation (Selection Bias) | Low Risk | Active-control, randomized, double-blind, parallel-group, clinical trial |
| Allocation Concealment (Selection Bias) | Low risk | Stratified Randomization |
| Blinding Of Participants & Personel (Performance Bias) | Low Risk | Double blind RCT |
| Blinding Of Outcome Assessment (Detection Bias) | Low Risk | Double blind RCT |
| Incomplete Outcome Data (Attrition Bias) | Low Risk | 1678 out of 1879 patients completed the study (attrition rate 10.69%) |
| Selective Reporting (Reporting Bias) | Low Risk | All Pre-Specified Outcomes Were Reported |
| Other Biases | High Rsk | Three authors employed by the sponsor contributed to the trial design, and two authors employed by the sponsor were responsible for the statistical analyses. The last author (who was employed by the sponsor) provided medical oversight during the trial. The study was funded and supported by Eli Lilly |
| Ludvik 2021 | Risk Of Bias | Author Judgement |
| Random Sequence Generation (Selection Bias) | Low Risk | Open-label, parallel-group, multicenter, multiethnic, phase 3 randomized controlled study |
| Allocation Concealment (Selection Bias) | Low risk | Assignment to treatment group was determined by a computer-generated random sequence using the Eli Lilly and Company interactive web response system. |
| Blinding Of Participants & Personal (Performance Bias) | High Risk | Open labelled study |
| Blinding Of Outcome Assessment (Detection Bias) | High Risk | Open labelled study |
| Incomplete Outcome Data (Attrition Bias) | Low risk | 726 patients were randomized to receive either tirzepatide 10mg/d or degludec insulin, of which 652 patients completed the study. Hence attrition was 74 patients (10.19%) |
| Selective Reporting (Reporting Bias) | Low Risk | All pre-specified outcomes were reported |
| Other Biases | High Risk | The study was funded by Eli Lilly and Company. |
| Rosenstock 2021 | Risk Of Bias | Author Judgement |
| Random Sequence Generation (Selection Bias) | Low Risk | Open-label, parallel-group, multicenter, multiethnic, phase 3 randomized placebo- controlled study of 4o week duration |
| Allocation Concealment (Selection Bias) | Low risk | Assignment to treatment group was determined by a computer-generated random sequence using the Eli Lilly and Company interactive web response system. |
| Blinding Of Participants & Personal (Performance Bias) | High Risk | Open labelled study |
| Blinding Of Outcome Assessment (Detection Bias) | High Risk | Open labelled study |
| Incomplete Outcome Data (Attrition Bias) | Low risk | 236 patients were randomized to receive either tirzepatide 10mg/d or placebo, of which 211 patients completed the study. Hence attrition was 25 patients (10.59%) |
| Selective Reporting (Reporting Bias) | Low Risk | All pre-specified outcomes were reported |
| Other Biases | High Risk | The study was funded by Eli Lilly and Company. |