Evidence map›Paper›PMID 23193209›Full record

Trial reportDiabetes care2013

Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study.

Julio Rosenstock, Richard M Bergenstal, Thomas C Blevins, Linda A Morrow, 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, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
9.5field-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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. A Narrative Review of Potential Future Antidiabetic Drugs: Should We Expect More?Indian journal of clinical biochemistry : IJCB · 2018
    Review
  11. Oral Insulin Delivery in a Physiologic Context: Review.Journal of diabetes science and technology · 2017
    Review
  12. Article
  13. 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
  14. Review
  15. Article
  16. Pursuit of a perfect insulin.Nature reviews. Drug discovery · 2016
    Review
  17. 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
  18. Concepts and clinical use of ultra-long basal insulin.Diabetology & metabolic syndrome · 2016
    Review
  19. 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

9 authors at 5 institutions in 1 country.

Julio RosenstockDallas Diabetes and Endocrine Center at Medical City Dallas, Dallas, TX, USA.
Richard M Bergenstal
Thomas C Blevins
Linda A Morrow
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 · USProfil Institute for Clinical Research · USTexas Diabetes & Endocrinology · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

OBJECTIVE To compare effects of LY2605541 versus insulin glargine on daily mean blood glucose as part of a basal-bolus regimen for type 1 diabetes. RESEARCH DESIGN AND METHODS In this randomized, Phase 2, open-label, 2 × 2 crossover study, 137 patients received once-daily basal insulin (LY2605541 or glargine) plus mealtime insulin for 8 weeks, followed by crossover treatment for 8 weeks. Daily mean blood glucose was obtained from 8-point self-monitored blood glucose profiles. The noninferiority margin was 10.8 mg/dL. RESULTS LY2605541 met noninferiority and superiority criteria compared with insulin glargine in daily mean blood glucose (144.2 vs. 151.7 mg/dL, least squares mean difference = -9.9 mg/dL [90% CI -14.6 to -5.2], P < 0.001). Fasting blood glucose variability and A1C were reduced with LY2605541 compared with insulin glargine (both P < 0.001). Mealtime insulin dose decreased with LY2605541 and increased with insulin glargine. Mean weight decreased 1.2 kg with LY2605541 and increased 0.7 kg with insulin glargine (P < 0.001). The total hypoglycemia rate was higher for LY2605541 (P = 0.04) and the nocturnal hypoglycemia rate was lower (P = 0.01), compared with insulin glargine. Adverse events (including severe hypoglycemia) were similar, although more gastrointestinal-related events occurred with LY2605541 (15% vs. 4%, P < 0.001). Mean changes (all within normal range) were higher for alanine aminotransferase, aspartate aminotransferase, triglycerides, and LDL-cholesterol and lower for HDL-cholesterol with LY2605541 compared with insulin glargine (all P < 0.02). CONCLUSIONS In type 1 diabetes, compared with insulin glargine, LY2605541, a novel, long-acting basal insulin, demonstrated greater improvements in glycemic control, increased total hypoglycemia, and reduced nocturnal hypoglycemia, as well as reduced weight and lowered mealtime insulin doses.

Indexed as

AdultCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingMaleTreatment OutcomeHypoglycemic AgentsInsulin GlargineInsulin, Long-Acting

Identifiers

PMID23193209
PMCPMC3579351
OpenAlexW2142370026

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.