Tirzepatide in prediabetes and progression to type 2 diabetes — evidence extract
The Institute's graded assessment of Tirzepatide for prediabetes and progression to type 2 diabetes, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Prediabetes and progression to type 2 diabetes
§1.1Question and anchor outcome
- Population
- Glucose regulation impaired beyond normal limits but below diagnostic thresholds for diabetes, including impaired fasting glucose, impaired glucose tolerance, and intermediate HbA1c.
- Intervention
- Tirzepatide, subcutaneous once weekly
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Incident type 2 diabetes
Additional outcomes the Institute extracts for this indication: Reversion to normoglycaemia; Change in HbA1c; Change in body weight.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Tirzepatide in prediabetes and progression to type 2 diabetes.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| SURMOUNT-1 | 3 | Randomised, double-blind, placebo-controlled | 2,539 | 72 weeks | 2022 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | Serious | A single small trial contributes the whole estimate. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine 2022;387(3):205–216. doi:10.1056/NEJMoa2206038 · PMID 35658024
- Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet 2023;402(10402):613–626. doi:10.1016/S0140-6736(23)01200-X · PMID 37385275
- Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nature Medicine 2023;29(11):2909–2918. doi:10.1038/s41591-023-02597-w · PMID 37840095
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.