Evidence mapPaperPMID 21285389Full record

Trial reportDiabetes care2011

A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial.

Tim Heise, Cees J Tack, Robert Cuddihy, Jaime Davidson, Didier Gouet, Andreas Liebl, Enrique Romero, Henriette Mersebach, Patrik Dykiel, Rolf Jorde

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00614055. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
10.6field-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.

NCT00614055 phase2completed

A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

Ran2008Enrolled178Registered outcomes13Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec/insulin aspart, Insulin glargine, Metformin
PMID 24124961PMID 22946603other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  11. Review
  12. Article
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  16. A review of the new GLP-1 receptor agonist/basal insulin fixed-ratio combination products.Therapeutic advances in endocrinology and metabolism · 2018
    Review
  17. Review
  18. Article
  19. Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal-Bolus): Exploratory Randomized Trial in Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017
    Article
  20. 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

10 authors at 9 institutions in 7 countries.

Tim HeiseProfil Institut für Stoffwechselforschung, Neuss, Germany. tim.heise@profil-research.de
Cees J Tack
Robert Cuddihy
Jaime Davidson
Didier Gouet
Andreas Liebl
Enrique Romero
Henriette Mersebach
Patrik Dykiel
Rolf Jorde
Novo Nordisk (Denmark) · DKCentre Hospitalier de La Rochelle · FRDiabetes-Akademie · DEPark Nicollet Clinic · USProfil Institute for Metabolic Research · DERadboud University Medical Center · NLThe University of Texas Southwestern Medical Center · USUiT The Arctic University of Norway · NOUniversidad de Valladolid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInsulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the novel basal analog insulin degludec (IDeg: 70%) and insulin aspart (IAsp: 30%). We compared the safety and efficacy of IDegAsp, an alternative formulation (AF) (55% IDeg and 45% IAsp), and insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes inadequately controlled with oral antidiabetic drugs. RESEARCH DESIGN AND

methodsIn this 16-week, open-label trial, subjects (mean age 59.1 years, A1C 8.5%, BMI 30.3 kg/m(2)) were randomized to once-daily IDegAsp (n = 59), AF (n = 59), or IGlar (n = 60), all in combination with metformin. Insulin was administered before the evening meal and dose-titrated to a fasting plasma glucose (FPG) target of 4.0-6.0 mmol/L.

resultsAfter 16 weeks, mean A1C decreased in all groups to comparable levels (IDegAsp: 7.0%; AF: 7.2%; IGlar: 7.1%). A similar proportion of subjects achieved A1C <7.0% without confirmed hypoglycemia in the last 4 weeks of treatment (IDegAsp: 51%; AF: 47%; IGlar: 50%). Mean 2-h postdinner plasma glucose increase was lower for IDegAsp (0.13 mmol/L) and AF (0.24 mmol/L) than IGlar (1.63 mmol/L), whereas mean FPG was similar (IDegAsp: 6.8 mmol/L; AF: 7.4 mmol/L; IGlar: 7.0 mmol/L). Hypoglycemia rates were lower for IDegAsp and IGlar than AF (1.2, 0.7, and 2.4 events/patient year). Nocturnal hypoglycemic events occurred rarely for IDegAsp (1 event) and IGlar (3 events) compared with AF (27 events).

conclusionsIn this proof-of-concept trial, once-daily IDegAsp was safe, well tolerated, and provided comparable overall glycemic control to IGlar at similar low rates of hypoglycemia, but better postdinner plasma glucose control.

Indexed as

AdolescentAdultAgedDiabetes Mellitus, Type 2FemaleHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin, Long-ActingMaleMiddle AgedTreatment OutcomeYoung AdultHypoglycemic AgentsInsulinInsulin GlargineInsulin, Long-Acting

Identifiers

PMID21285389
PMCPMC3041205
OpenAlexW2029761237

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.