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Study · Non-randomized trial · n = 303 · 2020

4 results

Risk factors and management of pasireotide-associated hyperglycemia in acromegaly.

Gadelha MR, Gu F, Bronstein MD, Brue TC, Fleseriu M, Shimon I, van der Lely AJ, Ravichandran S, Kandra A, Pedroncelli AM, Colao AAL

Endocrine connections1 Dec 2020Cited by 50 (Europe PMC)

PMID33434154 (opens in a new tab)PMCIDPMC7774766 (opens in a new tab)DOI10.1530/ec-20-0361 (opens in a new tab)PepBankPUB-33434154
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Summary

Pasireotide, a multireceptor-targeted somatostatin analog with highest affinity for somatostatin receptor subtype (SST) 5, has demonstrated superior efficacy over the SST2-preferential somatostatin analogs octreotide and lanreotide. The safety profile is similar to those of octreotide and lanreotide, except for a higher frequency and degree of hyperglycemia. This analysis investigated baseline characteristics and occurrence and management of hyperglycemia during pasireotide treatment in patients with acromegaly treated in two prospective clinical studies, SOM230C2305 (C2305) and SOM230C2402 (C2402; PAOLA). One hundred and seventy-eight patients naïve to medical therapy at baseline (C2305) and 125 uncontrolled on first-generation somatostatin analogs at baseline (C2402) received long-acting pasireotide in these studies. Of patients treated with pasireotide in studies C2305 and C2402, respectively, 75.3 (134/178) and 65.6% (82/125) developed hyperglycemia or experienced worsening of existing hyperglycemia. Occurrence of hyperglycemia during pasireotide treatment was less frequent in patients with lower age (<40 years, C2402; <30 years, C2305), normal glucose tolerance, and no history of hypertension or dyslipidemia at baseline. Thirteen (4%) patients discontinued pasireotide because of hyperglycemia-related adverse events. Metformin alone or in combination with other oral antidiabetic medications controlled elevations in glucose levels in most pasireotide-treated patients; 78% of C2305 patients and 73 (pasireotide 40 mg) and 60% (pasireotide 60 mg) of C2402 patients achieved the ADA/EASD goal of HbA1c <7% (<53 mmol/mol) at the end of the core phase. Not all patients develop hyperglycemia, and it is reversible upon pasireotide withdrawal. Close monitoring, patient education and prompt action remain key elements in addressing hyperglycemia during pasireotide treatment.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In patients with acromegaly, thirteen (4%) discontinued pasireotide because of hyperglycemia-related adverse events.

    In plain wordsIn patients with acromegaly, thirteen (4%) stopped pasireotide because of adverse events related to high blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia-related discontinuation
    Study

    n = 303

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Patients discontinuing pasireotide because of hyperglycemia-related adverse events
    13 patients
    both studies; 4%
    Proportion discontinuing because of hyperglycemia-related adverse events
    4%
    both studies

    Source sentences

    Summary
    Thirteen (4%) patients discontinued pasireotide because of hyperglycemia-related adverse events.
    2 context sentences
    Summary · context
    This analysis investigated baseline characteristics and occurrence and management of hyperglycemia during pasireotide treatment in patients with acromegaly treated in two prospective clinical studies, SOM230C2305 (C2305) and SOM230C2402 (C2402; PAOLA).
    Summary · context
    One hundred and seventy-eight patients naïve to medical therapy at baseline (C2305) and 125 uncontrolled on first-generation somatostatin analogs at baseline (C2402) received long-acting pasireotide in these studies.
  2. 02HumanNon-randomized trialSafety outcome

    In patients with acromegaly receiving pasireotide in C2305, 75.3% (134/178) developed or experienced worsening hyperglycemia.

    In plain wordsIn C2305, 75.3% of patients with acromegaly developed or experienced worsening high blood sugar during pasireotide treatment.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia, C2305
    Study

    n = 178

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Patients with hyperglycemia or worsening hyperglycemia
    75.3%
    C2305, 134/178

    Source sentences

    Summary
    Of patients treated with pasireotide in studies C2305 and C2402, respectively, 75.3 (134/178) and 65.6% (82/125) developed hyperglycemia or experienced worsening of existing hyperglycemia.
    2 context sentences
    Summary · context
    This analysis investigated baseline characteristics and occurrence and management of hyperglycemia during pasireotide treatment in patients with acromegaly treated in two prospective clinical studies, SOM230C2305 (C2305) and SOM230C2402 (C2402; PAOLA).
    Summary · context
    One hundred and seventy-eight patients naïve to medical therapy at baseline (C2305) and 125 uncontrolled on first-generation somatostatin analogs at baseline (C2402) received long-acting pasireotide in these studies.
  3. 03HumanNon-randomized trialSafety outcome

    In patients with acromegaly receiving pasireotide in C2402, 65.6% (82/125) developed or experienced worsening hyperglycemia.

    In plain wordsIn C2402, 65.6% of patients with acromegaly developed or experienced worsening high blood sugar during pasireotide treatment.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia, C2402
    Study

    n = 125

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Patients with hyperglycemia or worsening hyperglycemia
    65.6%
    C2402 (PAOLA), 82/125

    Source sentences

    Summary
    Of patients treated with pasireotide in studies C2305 and C2402, respectively, 75.3 (134/178) and 65.6% (82/125) developed hyperglycemia or experienced worsening of existing hyperglycemia.
    2 context sentences
    Summary · context
    This analysis investigated baseline characteristics and occurrence and management of hyperglycemia during pasireotide treatment in patients with acromegaly treated in two prospective clinical studies, SOM230C2305 (C2305) and SOM230C2402 (C2402; PAOLA).
    Summary · context
    One hundred and seventy-eight patients naïve to medical therapy at baseline (C2305) and 125 uncontrolled on first-generation somatostatin analogs at baseline (C2402) received long-acting pasireotide in these studies.
  4. 04HumanObservational studySafety outcome

    During pasireotide treatment for acromegaly, hyperglycemia was less frequent below age 40 in C2402 or 30 in C2305, with normal glucose tolerance, and without hypertension or dyslipidemia history.

    In plain wordsDuring pasireotide treatment, hyperglycemia was less frequent with younger age, normal glucose tolerance, and no hypertension or dyslipidemia history.

    Peptide
    Pasireotide
    Outcome
    DecreaseHyperglycemia risk factors
    Study

    n: not reported in source

    Comparator
    Patients without the listed baseline characteristics
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Occurrence of hyperglycemia during pasireotide treatment was less frequent in patients with lower age (<40 years, C2402; <30 years, C2305), normal glucose tolerance, and no history of hypertension or dyslipidemia at baseline.
    2 context sentences
    Summary · context
    This analysis investigated baseline characteristics and occurrence and management of hyperglycemia during pasireotide treatment in patients with acromegaly treated in two prospective clinical studies, SOM230C2305 (C2305) and SOM230C2402 (C2402; PAOLA).
    Summary · context
    One hundred and seventy-eight patients naïve to medical therapy at baseline (C2305) and 125 uncontrolled on first-generation somatostatin analogs at baseline (C2402) received long-acting pasireotide in these studies.

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

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. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:36 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

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