Liraglutide in prediabetes and progression to type 2 diabetes — evidence extract
The Institute's graded assessment of Liraglutide 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
- Liraglutide, subcutaneous once daily
- 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 Liraglutide in prediabetes and progression to type 2 diabetes.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| SCALE-PREDIABETES | 3 | Randomised, double-blind, placebo-controlled | 2,254 | 160 weeks | 2017 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Differential attrition exceeded the pre-specified threshold in one arm. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| 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.
- Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DCW, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JPH. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. New England Journal of Medicine 2015;373(1):11–22. doi:10.1056/NEJMoa1411892 · PMID 26132939
- Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JFE, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB. Liraglutide and cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine 2016;375(4):311–322. doi:10.1056/NEJMoa1603827 · PMID 27295427
- Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). The Lancet 2009;374(9683):39–47. doi:10.1016/S0140-6736(09)60659-0 · PMID 19515413
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.