Evidence map›Paper›PMID 23043166›Full record

Trial reportDiabetes care2012

Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long).

Bernard Zinman, Athena Philis-Tsimikas, Bertrand Cariou, Yehuda Handelsman, Helena W Rodbard, Thue Johansen, Lars Endahl, Chantal Mathieu, NN1250-3579 (BEGIN Once Long) Trial Investigators

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 129 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 10 pooled it
23.0field-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.

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

129 citing papers in PubMed, 10 syntheses or guidelines pooled it, 333 citations in OpenAlex.

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69 more citing papers are in PubMed but not listed here.

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

9 authors at 6 institutions in 5 countries.

Bernard ZinmanSamuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
Athena Philis-Tsimikas
Bertrand Cariou
Yehuda Handelsman
Helena W Rodbard
Thue Johansen
Lars Endahl
Chantal Mathieu
NN1250-3579 (BEGIN Once Long) Trial Investigators
Novo Nordisk (Denmark) · DKInstitut du Thorax · FRScripps Whittier Diabetes Institute · USTarzana Treatment Centers · USUniversitair Ziekenhuis Leuven · BEUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs). RESEARCH DESIGN AND

methodsIn this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7-10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9-4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis.

resultsIn all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI -0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar.

conclusionsInsulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec.

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin, Long-ActingMaleMiddle AgedTreatment OutcomeBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulininsulin degludecInsulin GlargineInsulin, Long-Acting

Identifiers

PMID23043166
PMCPMC3507614
OpenAlexW1965832529

What OpenQuestion 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 OpenQuestion graph.