Evidence map›Paper›PMID 27222510›Full record

Trial reportDiabetes care2016

Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.

Julio Rosenstock, Bruno Guerci, Markolf Hanefeld, Sandro Gentile, Ronnie Aronson, Francisco J Tinahones, Christine Roy-Duval, Elisabeth Souhami, Marek Wardecki, Jenny Ye and 3 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01768559. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
21.3field-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.

NCT01768559 phase3completed

A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Ran2013Enrolled894Registered outcomes15Posted comparisons3ConditionsType 2 DiabetesArmsInsulin Glargine (Mandatory background drug), Insulin glulisine QD, Insulin glulisine TID, Lixisenatide (AVE0010), Metformin (Background drug)
Open the trial in the graph
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 129 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

13 authors at 8 institutions in 6 countries.

Julio RosenstockDallas Diabetes and Endocrine Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.
Bruno GuerciUniversity of Lorraine and the Department of Diabetology, Metabolic Diseases and Nutrition, Brabois Adult Hospital, Vandœuvre-lès-Nancy, France.
Markolf HanefeldGWT-TUD, Study Centre Prof. Hanefeld, Dresden Technical University, Dresden, Germany.
Sandro GentileDepartment of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy.
Ronnie AronsonLMC Diabetes & Endocrinology, Toronto, Ontario, Canada.
Francisco J TinahonesCentre in Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health and Hospital Virgen de la Victoria, Malaga, Spain.
Christine Roy-DuvalSanofi, Paris, France.
Elisabeth SouhamiSanofi, Paris, France.
Marek WardeckiSanofi, Warsaw, Poland.
Jenny YeSanofi, Bridgewater, NJ.
Riccardo PerfettiSanofi, Bridgewater, NJ.
Simon HellerAcademic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, U.K.
GetGoal Duo-2 Trial Investigators
Sanofi (France) · FRSanofi (United States) · USDallas Diabetes Research Center · USGWT-TUD (Germany) · DELMC Diabetes & Endocrinology (Canada) · CASpanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition · ESUniversité de Lorraine · FRUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs). RESEARCH DESIGN AND

methodsPatients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization. Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound <0.4% [<4.4 mmol/mol]) in HbA1c reduction with lixisenatide versus glulisine once daily, and either 2a) noninferiority in HbA1c reduction for lixisenatide versus glulisine thrice daily or 2b) superiority in body weight change for lixisenatide versus glulisine thrice daily. Fasting and postprandial plasma glucose, composite efficacy/safety end points, and adverse events were also assessed.

resultsBaseline characteristics were similar between arms (n = 298, diabetes and basal insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m(2)). HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met. Symptomatic hypoglycemia and body weight were lower in lixisenatide versus glulisine patients. More gastrointestinal events occurred with lixisenatide.

conclusionsShort-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin may become a preferred treatment intensification option, attaining meaningful glycemic targets with fewer hypoglycemic events without weight gain versus basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes.

Indexed as

AgedBlood GlucoseBody Mass IndexBody WeightDiabetes Mellitus, Type 2Drug Therapy, CombinationEndpoint DeterminationFemaleGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineBlood GlucoseGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentsInsulin GlarginelixisenatideMetforminPeptides

Identifiers

PMID27222510
OpenAlexW2404273804

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

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.