Evidence mapPaperPMID 29430801Full record

Trial reportDiabetes, obesity & metabolism2018

Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration.

Kevin M Pantalone, Hiren Patel, Maria Yu, Laura Fernández Landó

Abstract readClinical Trial, Phase IIIEquivalence TrialMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
field-weighted citation impact
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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Trial
  3. Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Article
  4. Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Dulaglutide and Insulin: How Can the AWARD Studies Help Guide Clinical Practice?Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
  10. Article
  11. Review
  12. Article
  13. Article
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

4 authors.

Kevin M PantaloneDepartment of Endocrinology, Cleveland Clinic, Cleveland, Ohio.ORCID 0000-0002-3897-4551
Hiren PatelEli Lilly and Company, Indianapolis, Indiana.
Maria YuEli Lilly and Company, Toronto, Canada.
Laura Fernández LandóEli Lilly and Company, Indianapolis, Indiana.ORCID 0000-0002-0969-6214

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess efficacy and safety of dulaglutide 1.5 mg combined with insulin, categorized by subgroups of baseline glycated haemoglobin (HbA1c; ≤9% and >9% [≤74.9 and >74.9 mmol/mol]), age (<65 and ≥65 years), and duration of diabetes (<10 and ≥10 years) at 6 months in patients with type 2 diabetes (T2D). MATERIALS AND

methodsThis pooled analysis was conducted in a population of patients with T2D with similar baseline characteristics who were included in the AWARD-4 and AWARD-9 clinical trials and randomized to dulaglutide 1.5 mg (pooled mean baseline age 59 years, duration of diabetes 13 years, HbA1c 8.4% [68.3 mmol/mol]). Weight and hypoglycaemia were analysed by individual trial. In AWARD-4, dulaglutide plus lispro three times daily was assessed against glargine plus lispro three times daily. In AWARD-9, dulaglutide added to glargine was assessed against placebo added to glargine. Insulins were titrated to target in both trials.

resultsA total of 445 patients were included in this analysis (73% with HbA1c ≤9%, 27% [≤74.9 mmol/mol] with HbA1c >9% [>74.9 mmol/mol]; 70% aged <65 years, 30% aged ≥65 years; 36% with duration of diabetes <10 years, 64% with duration of diabetes ≥10 years). At 6 months, dulaglutide 1.5 mg significantly reduced HbA1c in all subgroups (P < .001), with the highest reduction observed in patients with baseline HbA1c >9% (>74.9 mmol/mol) (range - 1.3% to -2.5% [-14.2 to -27.3 mmol/mol]). The incidence rates of documented symptomatic and severe hypoglycaemia were similar in all subgroups in both trials. The most common adverse events observed in each trial were gastrointestinal in nature.

conclusionDulaglutide 1.5 mg combined with basal or prandial insulin is efficacious for patients with T2D irrespective of age, duration of diabetes or baseline HbA1c.

Indexed as

AdultAgedAge FactorsAnalysis of VarianceBody WeightDiabetes Mellitus, Type 2Drug Administration ScheduleDrug Therapy, CombinationFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsImmunoglobulin Fc FragmentsInsulin GlarginedulaglutideGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsImmunoglobulin Fc FragmentsInsulin GlargineInsulin LisproRecombinant Fusion ProteinsdulaglutideGLP-1 receptor agonisttype 2 diabetes

Identifiers

PMID29430801
PMCPMC5969314

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.