Evidence map›Paper›PMID 22787177›Full record

Trial reportDiabetes care2012

A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes.

Richard M Bergenstal, Julio Rosenstock, Richard F Arakaki, Melvin J Prince, Yongming Qu, Vikram P Sinha, Daniel C Howey, Scott J Jacober

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 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
12.7field-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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. A Narrative Review of Potential Future Antidiabetic Drugs: Should We Expect More?Indian journal of clinical biochemistry : IJCB · 2018
    Review
  10. Article
  11. Article
  12. How Can a Good Idea Fail? Basal Insulin Peglispro [LY2605541] for the Treatment of Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017
    Review
  13. Controlled release of biologics for the treatment of type 2 diabetes.Journal of controlled release : official journal of the Controlled Release Society · 2016
    Review
  14. Review
  15. Article
  16. Advances in Insulin Therapy: A Review of New Insulin Glargine 300 Units/mL in the Management of Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2016
    Article
  17. Concepts and clinical use of ultra-long basal insulin.Diabetology & metabolic syndrome · 2016
    Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Richard M BergenstalInternational Diabetes Center at Park Nicollet, Minneapolis, MN, USA.
Julio Rosenstock
Richard F Arakaki
Melvin J Prince
Yongming Qu
Vikram P Sinha
Daniel C Howey
Scott J Jacober
Eli Lilly (United States) · USDallas Diabetes Research Center · USPark Nicollet Clinic · USUniversity of Hawaiʻi at Mānoa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether LY2605541 results in lower fasting blood glucose (FBG) versus insulin glargine (GL). RESEARCH DESIGN AND

methodsThis 12-week, randomized, open-label, Phase 2 study enrolled patients with type 2 diabetes (hemoglobin A(1c) [A1C] ≤ 10.5%), taking metformin and/or sulfonylurea with GL or NPH insulin once daily. Patients converted to morning insulin administration during lead-in were randomized 2:1 from GL (n = 248) or NPH insulin (n = 39) to LY2605541 (n = 195) or GL (n = 95) once daily in the morning.

resultsAt 12 weeks, FBG (mean ± SE) was similar with LY2605541 and GL (118.2 ± 2.0 mg/dL [6.6 ± 0.1 mmol/L] vs. 116.9 ± 2.7 mg/dL [6.5 ± 0.2 mmol/L], P = 0.433) as was A1C (7.0 ± 0.1 vs. 7.2 ± 0.1%, P = 0.279). Intraday blood glucose variability was reduced with LY2605541 (34.4 vs. 39.1 mg/dL [1.9 vs. 2.2 mmol/L], P = 0.031). LY2605541 patients had weight loss (-0.6 ± 0.2 kg, P = 0.007), whereas GL patients gained weight (0.3 ± 0.2 kg, P = 0.662; treatment difference: -0.8 kg, P = 0.001). The incidence and rate of both total hypoglycemia and nocturnal hypoglycemia were comparable between LY2605541 and GL, although, LY2605541 had a 48% reduction in nocturnal hypoglycemia after adjusting for baseline hypoglycemia (P = 0.021). Adverse events were similar across treatments. Alanine aminotransferase and aspartate aminotransferase remained within normal range but were significantly higher with LY2605541 (P ≤ 0.001).

conclusionsIn patients with type 2 diabetes, LY2605541 and GL had comparable glucose control and total hypoglycemia rates, but LY2605541 showed reduced intraday variability, lower nocturnal hypoglycemia, and weight loss relative to GL.

Indexed as

Diabetes Mellitus, Type 2Drug Administration ScheduleFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin LisproInsulin, Long-ActingMalePolyethylene GlycolsGlycated HemoglobinHypoglycemic AgentsInsulinInsulin GlargineInsulin LisproInsulin, Long-ActingLY2605541Polyethylene Glycols

Identifiers

PMID22787177
PMCPMC3476888
OpenAlexW1966710530

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.