Evidence map›Paper›PMID 35671039›Full record

Trial reportDiabetes care2022

Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial.

Juan Pablo Frias, JaeDuk Choi, Julio Rosenstock, Luiza Popescu, Elisabeth Niemoeller, Isabel Muehlen-Bartmer, Seungjae Baek

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
4.5field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.

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  20. Research Advances in Fusion Protein-Based Drugs for Diabetes Treatment.Diabetes, metabolic syndrome and obesity : targets and therapy · 2024
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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

7 authors at 4 institutions in 3 countries.

Juan Pablo FriasNational Research Institute, Los Angeles, CA.ORCID 0000-0001-9486-1255
JaeDuk ChoiHanmi Pharmaceutical Co., Ltd, Seoul, Korea.
Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, TX.ORCID 0000-0001-8324-3275
Luiza PopescuSanofi, Bucharest, Romania.
Elisabeth NiemoellerSanofi, Frankfurt, Germany.
Isabel Muehlen-BartmerSanofi, Frankfurt, Germany.
Seungjae BaekHanmi Pharmaceutical Co., Ltd, Seoul, Korea.ORCID 0000-0003-3385-2077
Hanmi Pharmaceutical (South Korea) · KRSanofi (Germany) · DEDallas Diabetes Research Center · USNational Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of the glucagon-like peptide 1 receptor agonist (GLP-1 RA) efpeglenatide versus placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone. RESEARCH DESIGN AND

methodsAMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks. The primary objective was to demonstrate the superiority of efpeglenatide versus placebo for HbA1c reduction at week 30. Secondary objectives included changes in other measures of glycemic control and body weight at weeks 30 and 56.

resultsAt week 30, HbA1c was reduced from a baseline of 8.1% (65 mmol/mol) to 6.9% (52 mmol/mol), 6.6% (49 mmol/mol), and 6.4% (47 mmol/mol) with efpeglenatide 2, 4, and 6 mg, respectively. Least squares mean HbA1c reductions from baseline were statistically superior for each efpeglenatide dose versus placebo (2 mg, -0.5% [95% CI -0.9, -0.2; P = 0.0054]; 4 mg, -0.8% [-1.2, -0.5; P < 0.0001]; 6 mg, -1.0% [-1.4, -0.7; P < 0.0001]). A greater proportion of efpeglenatide-treated patients (all doses) achieved HbA1c <7% (53 mmol/mol) versus placebo by week 30 (P < 0.0001 for all), and significant reductions in body weight and fasting plasma glucose were also observed for efpeglenatide (4 and 6 mg doses) versus placebo at week 30 (P < 0.05 for all). Consistent with the GLP-1 RA class, gastrointestinal adverse events were most commonly reported; these were generally transient and mild/moderate in severity. Few patients reported hypoglycemia.

conclusionsAs monotherapy in patients with type 2 diabetes, once-weekly efpeglenatide significantly improved glycemic control and body weight with a safety and tolerability profile similar to that of other GLP-1 RAs.

Indexed as

Diabetes Mellitus, Type 2MetforminAdultBlood GlucoseBody WeightDouble-Blind MethodDrug Therapy, CombinationGlucagon-Like Peptide 1Glycated HemoglobinHumansHypoglycemic AgentsProlineTreatment OutcomeBlood GlucoseefpeglenatideGlucagon-Like Peptide 1Glycated HemoglobinHypoglycemic AgentsMetforminProline

Identifiers

PMID35671039
PMCPMC9274225
OpenAlexW4281678519

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

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 Socratic graph.