Evidence map›Paper›PMID 19930005›Full record

Trial reportDiabetes, obesity & metabolism2009

Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study.

M J Davies, R Donnelly, A H Barnett, S Jones, C Nicolay, A Kilcoyne

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00360334 (An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone), which is not on this map. Cited by 55 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 11 pooled it
9.6field-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.

NCT00360334 phase3completednot on this map

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

TypeinterventionalSponsorAstraZenecaRan2006 to 2008Enrolled235ConditionsType 2 DiabetesArmsexenatide, insulin glargine
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 11 syntheses or guidelines pooled it, 148 citations in OpenAlex.

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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

6 authors at 6 institutions in 2 countries.

M J DaviesDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK. melanie.davies@uhl-tr.nhs.uk
R Donnelly
A H Barnett
S Jones
C Nicolay
A Kilcoyne
Eli Lilly (Germany) · DEEli Lilly (United Kingdom) · GBHeart of England NHS Foundation Trust · GBJames Cook University Hospital · GBUniversity of Leicester · GBUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe Helping Evaluate Exenatide in overweight patients with diabetes compared with Long-Acting insulin (HEELA) study was designed to examine whether the glucagon-like peptide-1 (GLP-1) receptor agonist, exenatide, could improve HbA1c (< or =7.4%) with minimal weight gain (< or =1 kg) compared with insulin glargine.

methodsPatients [body mass index (BMI) >27 kg/m(2)] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 microg b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < or =5.6 mmol/l; n = 117) for 26 weeks.

resultsThe study population had baseline mean (s.d.) age of 56.5 (9.1) years and BMI of 34.1 (5.3) kg/m(2), and 58.5% of patients were taking two OADs. Mean baseline HbA1c was 8.65 (0.68)% in the exenatide group and 8.48 (0.66)% in the insulin glargine group. The proportions of patients achieving the composite endpoint of HbA1c < or =7.4% with weight gain < or =1 kg were 53.4% for the exenatide group and 19.8% for the insulin glargine group (p < 0.001 for exenatide vs. insulin glargine). Exenatide and insulin glargine did not demonstrate a significant difference in HbA1c improvements [least square (LS) mean [s.e.m.]: -1.25 [0.09]% and -1.26 [0.09]% respectively; p = 0.924], but had divergent effects on body weight (-2.73 [0.31] vs. +2.98 [0.31] kg respectively, p < 0.001) after 26 weeks. There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.

conclusionsAdditional treatment with exenatide resulted in significantly more overweight and obese patients with an elevated cardiovascular risk and type 2 diabetes achieving better glycaemic control with minimal weight gain compared with insulin glargine.

Indexed as

Diabetes Mellitus, Type 2ExenatideFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin, Long-ActingMaleMiddle AgedPeptidesTreatment OutcomeUnited KingdomVenomsWeight GainExenatideGlycated HemoglobinHypoglycemic AgentsInsulin, Long-ActingPeptidesVenoms

Identifiers

PMID19930005
PMCPMC2810445
OpenAlexW2078090288

What Socratic 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 Socratic graph.