Dulaglutide in chronic kidney disease in type 2 diabetes — evidence extract
The Institute's graded assessment of Dulaglutide for chronic kidney disease in type 2 diabetes, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Chronic kidney disease in type 2 diabetes
§1.1Question and anchor outcome
- Population
- Persistent reduction in estimated glomerular filtration rate or persistent albuminuria in the context of type 2 diabetes, staged by eGFR and urine albumin-to-creatinine ratio.
- Intervention
- Dulaglutide, subcutaneous once weekly
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Composite kidney outcome (kidney failure, sustained ≥50 % eGFR decline, kidney or cardiovascular death)
Additional outcomes the Institute extracts for this indication: Annual eGFR slope; Change in urine albumin-to-creatinine ratio.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Dulaglutide in chronic kidney disease in type 2 diabetes.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| AWARD-7 | 3 | Randomised, open-label, active-controlled | 576 | 52 weeks | 2018 |
§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 | Very serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| 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: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from 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.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet 2019;394(10193):121–130. doi:10.1016/S0140-6736(19)31149-3 · PMID 31189511
- Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet Diabetes & Endocrinology 2018;6(4):275–286. doi:10.1016/S2213-8587(18)30024-X · PMID 29397376
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
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.