Danuglipron in type 2 diabetes mellitus — evidence extract
The Institute's graded assessment of Danuglipron for type 2 diabetes mellitus, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Type 2 diabetes mellitus
§1.1Question and anchor outcome
- Population
- A disorder of glucose regulation characterised by insulin resistance with relative insulin deficiency, diagnosed by glycated haemoglobin, fasting plasma glucose or oral glucose tolerance criteria.
- Intervention
- Danuglipron, oral, twice daily in the phase 2b programme
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in HbA1c (%, mmol/mol)
Additional outcomes the Institute extracts for this indication: Proportion achieving HbA1c <7.0 % and ≤6.5 %; Change in fasting serum glucose; Change in body weight; Documented symptomatic hypoglycaemia.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Danuglipron in type 2 diabetes mellitus.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| DANU-PH2B-T2D | 2b | Randomised, double-blind, placebo-controlled | 411 | 16 weeks | 2023 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Contributing trials are sponsor-conducted and one is open-label. |
| 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.
- Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ. Efficacy and safety of oral small molecule glucagon-like peptide 1 receptor agonist danuglipron for glycemic control among patients with type 2 diabetes: a randomized clinical trial. JAMA Network Open 2023;6(5):e2314493. doi:10.1001/jamanetworkopen.2023.14493 · PMID 37237090
- Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH Harmonised Guideline 2023;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.