Liraglutide in adjunctive therapy in type 1 diabetes — evidence extract
The Institute's graded assessment of Liraglutide for adjunctive therapy in type 1 diabetes, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Adjunctive therapy in type 1 diabetes
§1.1Question and anchor outcome
- Population
- Use alongside insulin in autoimmune diabetes, where the therapeutic target is postprandial excursion, insulin dose or weight rather than endogenous insulin secretion.
- Intervention
- Liraglutide, subcutaneous once daily
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in HbA1c
Additional outcomes the Institute extracts for this indication: Change in total daily insulin dose; Time in range on continuous glucose monitoring; Severe hypoglycaemia; Diabetic ketoacidosis.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Liraglutide in adjunctive therapy in type 1 diabetes.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| ADJUNCT-ONE | 3 | Randomised, double-blind, placebo-controlled | 1,398 | 52 weeks | 2016 |
| ADJUNCT-TWO | 3 | Randomised, double-blind, placebo-controlled | 835 | 26 weeks | 2016 |
§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 | Serious | Direction is consistent; magnitude varies with the intensity of the background intervention. |
| 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.