Evidence mapPaperPMID 34275099Full record

Trial reportPituitary2021

Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study.

Susan L Samson, Feng Gu, Ulla Feldt-Rasmussen, Shaoling Zhang, Yerong Yu, Przemysław Witek, Pramila Kalra, Alberto M Pedroncelli, Philippe Pultar, Nadine Jabbour and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pituitary, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02060383 (A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly), which is not on this map. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT02060383 phase4completednot on this map

A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2018Enrolled249ConditionsCushing's Disease, AcromegalyArmsPasireotide s.c., Sitagliptin, Liraglutide, Insulin, Pasireotide LAR
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Acromegaly complications: an update.The Journal of clinical endocrinology and metabolism · 2026
    Review
  7. Current controversies in acromegaly care.The Journal of clinical endocrinology and metabolism · 2026
    Review
  8. Review
  9. Article
  10. European survey on metabolic and cardiovascular risk in Cushing syndrome.Journal of endocrinological investigation · 2025
    Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Acromegaly: diagnostic challenges and individualized treatment.Expert review of endocrinology & metabolism · 2025
    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

12 authors at 10 institutions in 6 countries.

Susan L SamsonBaylor College of Medicine, Houston, TX, USA. samson.susan@mayo.edu.ORCID http://orcid.org/0000-0002-8159-7093
Feng GuPeking Union Medical College Hospital, Beijing, China.
Ulla Feldt-RasmussenCentre for Cancer and Organ Diseases, Rigshospitalet, Copenhagen University, Copenhagen, Denmark.
Shaoling ZhangSun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Yerong YuWest China Hospital, Sichuan University, Chengdu, China.
Przemysław WitekMilitary Institute of Medicine and Medical University of Warsaw, Warsaw, Poland.
Pramila KalraMS Ramaiah Medical College and Hospitals, Bengaluru, India.
Alberto M PedroncelliNovartis Pharma AG, Basel, Switzerland.
Philippe PultarNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Nadine JabbourNovartis Pharma AG, Basel, Switzerland.
Michaela PaulNovartis Pharma AG, Basel, Switzerland.
Marek BolanowskiWroclaw Medical University, Wroclaw, Poland.
Novartis (Switzerland) · CHBaylor College of Medicine · USChinese Academy of Medical Sciences & Peking Union Medical College · CNCopenhagen University Hospital · DKMedical University of Warsaw · PLM.S. Ramaiah Medical College · INNovartis (United States) · USSichuan University · CNSun Yat-sen University · CNWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePasireotide is an effective treatment for acromegaly and Cushing's disease, although treatment-emergent hyperglycemia can occur. The objective of this study was to assess incretin-based therapy versus insulin for managing pasireotide-associated hyperglycemia uncontrolled by metformin/other permitted oral antidiabetic drugs.

methodsMulticenter, randomized, open-label, Phase IV study comprising a core phase (≤ 16-week pre-randomization period followed by 16-week randomized treatment period) and optional extension (ClinicalTrials.gov ID: NCT02060383). Adults with acromegaly (n = 190) or Cushing's disease (n = 59) received long-acting (starting 40 mg IM/28 days) or subcutaneous pasireotide (starting 600 µg bid), respectively. Patients with increased fasting plasma glucose (≥ 126 mg/dL on three consecutive days) during the 16-week pre-randomization period despite metformin/other oral antidiabetic drugs were randomized 1:1 to open-label incretin-based therapy (sitagliptin followed by liraglutide) or insulin for another 16 weeks. The primary objective was to evaluate the difference in mean change in HbA

resultsEighty-one (32.5%) patients were randomized to incretin-based therapy (n = 38 received sitagliptin, n = 28 subsequently switched to liraglutide; n = 12 received insulin as rescue therapy) or insulin (n = 43). Adjusted mean change in HbA

conclusionMany patients receiving pasireotide do not develop hyperglycemia requiring oral antidiabetic drugs. Metformin is an effective initial treatment, followed by incretin-based therapy if needed. ClinicalTrials.gov ID: NCT02060383.

Indexed as

Diabetes Mellitus, Type 2HyperglycemiaPituitary ACTH HypersecretionAdultBlood GlucoseHumansHypoglycemic AgentsSomatostatinBlood GlucoseHypoglycemic AgentspasireotideSomatostatinAcromegalyCushing’sHyperglycemiaIncretin-based therapyInsulinPasireotide

Identifiers

PMID34275099
PMCPMC8550309
OpenAlexW3183824698

What Socratic holds

Textmetadata
LicenceCC BY
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.