Evidence map›Paper›PMID 30203123›Full record

Trial reportEndocrine2018

Single and multiple ascending-dose study of glucagon-receptor antagonist RN909 in type 2 diabetes: a phase 1, randomized, double-blind, placebo-controlled trial.

Barry Gumbiner, Brooke Esteves, Vanessa Dell, Tenshang Joh, Pamela D Garzone, Alison Forgie, Chandrasekhar Udata

Abstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Endocrine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

8 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Glucagon receptor signaling at white adipose tissue does not regulate lipolysis.American journal of physiology. Endocrinology and metabolism · 2022
    Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Metabolic effects of glucagon in humans.Journal of clinical & translational endocrinology · 2019
    Review
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 1 institution in 1 country.

Barry GumbinerPfizer Inc., 10777 Science Center Dr, San Diego, CA, 92121, USA. barry.gumbiner@pfizer.com.
Brooke EstevesPfizer Inc., 7 Shipley Circle, Westford, MA, 01886, USA.
Vanessa DellPfizer Inc. Maine, 235 E. 42nd Street, New York, NY, 10017, USA.
Tenshang JohPfizer Inc., 10646 Science Center Drive, La Jolla, CA, 92121, USA.
Pamela D GarzonePfizer Inc., 230 East Grand Ave, South San Francisco, CA, 94080, USA.
Alison ForgiePfizer Inc., 10646 Science Center Drive, La Jolla, CA, 92121, USA.
Chandrasekhar UdataPfizer Inc., 10646 Science Center Drive, La Jolla, CA, 92121, USA.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis first-in-human study assessed safety, immunogenicity, pharmacokinetics, and pharmacodynamics of RN909, a monoclonal antibody antagonist of the glucagon receptor, in type 2 diabetes (T2DM) subjects.

methodsThis study enrolled 84 T2DM subjects receiving stable metformin regimens. Forty-four subjects were randomized to receive single escalating doses of RN909 (0.3 to 6 mg/kg subcutaneously (SC), or 1 mg/kg intravenously (IV)), or placebo; 40 subjects were randomized to receive multiple escalating doses (50 to 150 mg SC) or placebo every 4 weeks for 12 weeks.

resultsRN909 was well tolerated; treatment-related elevated liver function tests (LFTs) were observed in 4/33 (12.1%) and 5/32 (15.6%) subjects treated with single and multiple doses, respectively, versus 1/10 (10%) and 0 in the respective placebo groups. RN909 dose-normalized AUC

conclusionRN909 was well tolerated after single and multiple doses in T2DM subjects, with diarrhea and elevated LFTs the most frequent adverse events. The appearance of ADA did not affect pharmacokinetics or efficacy. Robust lowering of FPG and HbA1c was observed.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleHumansHypoglycemic AgentsMaleMetforminMiddle AgedPlacebosReceptors, GlucagonAntibodies, Monoclonal, HumanizedBlood GlucoseHypoglycemic AgentsMetforminPlacebosReceptors, GlucagonRN909GlucagonGlucoseRN909SafetyType 2 diabetes mellitus

Identifiers

PMID30203123
OpenAlexW2892037130

What OpenQuestion 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 OpenQuestion graph.