Evidence map›Paper›PMID 35403793›Full record

Trial reportDiabetes, obesity & metabolism2022

Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease.

Victoria E R Parker, Thuong Hoang, Heike Schlichthaar, Fraser W Gibb, Barbara Wenzel, Maximillian G Posch, Ludger Rose, Yi-Ting Chang, Marcella Petrone, Lars Hansen and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03550378 (A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
8.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03550378 phase2completednot on this map

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment

TypeinterventionalSponsorMedImmune LLCRan2018 to 2019Enrolled41ConditionsType II Diabetes Mellitus, Renal InsufficiencyArmsMEDI0382, Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  13. How to individualize renoprotective therapy in obese patients with chronic kidney disease: a commentary by the Diabesity Working Group of the ERA.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 8 countries.

Victoria E R ParkerResearch and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.ORCID 0000-0003-2706-2669
Thuong HoangGW Pharmaceuticals, Cambridge, UK.
Heike SchlichthaarStudy Center, SMO.MD GmbH, Magdeburg, Germany.
Fraser W GibbRoyal Infirmary of Edinburgh, Edinburgh, UK.
Barbara WenzelAPEX GmbH, Munich, Germany.
Maximillian G PoschCharite Research Organisation GmbH, Berlin, Germany.
Ludger RoseZentrum fur Diabetes, Münster, Germany.
Yi-Ting ChangEarly Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Marcella PetroneClinical Pharmacology and Safety Sciences, AstraZeneca, Cambridge, UK.
Lars HansenEarly Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Philip AmberyLate Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0000-0003-2978-1886
Lutz JermutusResearch and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, The Netherlands.ORCID 0000-0002-3126-3730
Rory J McCrimmonSchool of Medicine, Ninewells Hospital, University of Dundee, Dundee, UK.ORCID 0000-0002-3957-1981
AstraZeneca (United Kingdom) · GBAstraZeneca (Poland) · PLAstraZeneca (Finland) · FICharité - Universitätsmedizin Berlin · DEEdinburgh Royal Infirmary · GBGerman Center for Diabetes Research · DEGW Pharmaceuticals (United Kingdom) · GBUniversity Hospital Magdeburg · DEUniversity of Dundee · GBUniversity of Groningen · NLWilex (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the efficacy, safety and tolerability of cotadutide in patients with type 2 diabetes mellitus and chronic kidney disease. MATERIALS AND

methodsIn this phase 2a study (NCT03550378), patients with body mass index 25-45 kg/m

resultsParticipants receiving cotadutide (n = 21) had significant reductions in the mixed-meal tolerance test area under the glucose concentration-time curve (-26.71% vs. +3.68%, p < .001), more time in target glucose range on continuous glucose monitoring (+14.79% vs. -21.23%, p = .001) and significant reductions in absolute bodyweight (-3.41 kg vs. -0.13 kg, p < .001) versus placebo (n = 20). In patients with baseline micro- or macroalbuminuria (n = 18), urinary albumin-to-creatinine ratios decreased by 51% at day 32 with cotadutide versus placebo (p = .0504). No statistically significant difference was observed in mean change in estimated glomerular filtration rate between treatments. Mild/moderate adverse events occurred in 71.4% of participants receiving cotadutide and 35.0% receiving placebo.

conclusionsWe established the efficacy of cotadutide in this patient population, with significantly improved postprandial glucose control and reduced bodyweight versus placebo. Reductions in urinary albumin-to-creatinine ratios suggest potential benefits of cotadutide on kidney function, supporting further evaluation in larger, longer-term clinical trials.

Indexed as

Diabetes Mellitus, Type 2Renal Insufficiency, ChronicAlbuminsBlood GlucoseBlood Glucose Self-MonitoringBody WeightCreatinineDouble-Blind MethodGlucagonGlucagon-Like Peptide 1Glucagon-Like Peptide-1 Receptor AgonistsGlycated HemoglobinHumansHypoglycemic AgentsPeptidesReceptors, GlucagonAlbuminsBlood GlucosecotadutideCreatinineGlucagonGlucagon-Like Peptide 1Glucagon-Like Peptide-1 Receptor AgonistsGlycated HemoglobinHypoglycemic AgentsPeptidesReceptors, Glucagon

Identifiers

PMID35403793
PMCPMC9323481
OpenAlexW4223420336

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.