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Study · Not a test of the peptide alone · 2021

2 results

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

Samson SL, Gu F, Feldt-Rasmussen U, Zhang S, Yu Y, Witek P, Kalra P, Pedroncelli AM, Pultar P, Jabbour N, Paul M, Bolanowski M

Pituitary18 Jul 2021Cited by 56 (Europe PMC)

PMID34275099 (opens in a new tab)PMCIDPMC8550309 (opens in a new tab)DOI10.1007/s11102-021-01161-4 (opens in a new tab)PepBankPUB-34275099
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Summary

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 HbA1c from randomization to end of core phase between incretin-based therapy and insulin treatment arms.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 HbA1c between treatment arms was - 0.28% (95% CI - 0.63, 0.08) in favor of incretin-based therapy. The most common AE other than hyperglycemia was diarrhea (incretin-based therapy, 28.9%; insulin, 30.2%). Forty-six (18.5%) patients were managed on metformin (n = 43)/other OAD (n = 3), 103 (41.4%) patients did not require any oral antidiabetic drugs and 19 patients (7.6%) were receiving insulin at baseline and were not randomized.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.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone2

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

  1. 01HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In adults with pasireotide-associated hyperglycaemia, incretin-based therapy (sitagliptin followed by liraglutide) did not differ clearly from insulin in HbA1c change; the confidence interval included zero.

    In plain wordsIn adults with high blood sugar caused by pasireotide, sitagliptin then liraglutide and insulin gave similar HbA1c changes.

    Peptide
    Liraglutide
    Outcome
    No significant changeHbA1c change from randomization to end of core phase
    Study

    n = 81

    Comparator
    Insulin
    Analysis
    Primary
    Outcome group
    Glycemic control · Endocrine and hormones

    Measurements

    Adjusted mean HbA1c difference
    −0.28%
    incretin-based therapy versus insulin

    Source sentences

    Summary
    Adjusted mean change in HbA1c between treatment arms was - 0.28% (95% CI - 0.63, 0.08) in favor of incretin-based therapy.
    1 context sentence
    Summary · context
    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.

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

  2. 02HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome

    In adults with pasireotide-associated hyperglycaemia, diarrhoea occurred in 28.9% with incretin-based therapy (sitagliptin followed by liraglutide) and 30.2% with insulin.

    In plain wordsIn adults with pasireotide-related high blood sugar, diarrhoea was similarly common with sitagliptin then liraglutide and with insulin.

    Peptide
    Liraglutide
    Outcome
    Not applicableDiarrhoea
    Study

    n = 81

    Comparator
    Insulin
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Measurements

    Diarrhoea
    28.9%
    incretin-based therapy
    Diarrhoea
    30.2%
    insulin

    Source sentences

    Summary
    The most common AE other than hyperglycemia was diarrhea (incretin-based therapy, 28.9%; insulin, 30.2%).
    1 context sentence
    Summary · context
    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.

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT02060383

Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

Novartis Pharmaceuticalsn = 24923 May 2014 to 26 Mar 2018

Cushing's Disease · Acromegaly

Trial pageClinicalTrials.govUpdated 29 May 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Versions 4 to 5Current

    28 Oct 2026, 02:03 UTC

    The same notice was added 2 times, first on 28 Oct 2026, 02:03 UTC. The status did not change between them.

    Study results updated

  2. Version 3

    27 Oct 2026, 16:34 UTC

    Study data updated · source update from Europe PMC

  3. Version 2

    12 Oct 2026, 11:11 UTC

    Study results updated

  4. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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