Skip to content

Study · Non-randomized trial · n = 190 · 2024

8 results

Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing's disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study.

Feldt-Rasmussen U, Bolanowski M, Zhang SL, Yu Y, Witek P, Kalra P, Kietsiriroje N, Piacentini A, Pedroncelli AM, Samson SL

Frontiers in endocrinology21 Mar 2024Cited by 10 (Europe PMC)

PMID38577574 (opens in a new tab)PMCIDPMC10993249 (opens in a new tab)DOI10.3389/fendo.2024.1250822 (opens in a new tab)PepBankPUB-38577574
Download PDFPubMedAsk about this study
Jump to 8 results

Summary

IntroductionPasireotide, a somatostatin receptor ligand, is approved for treating acromegaly and Cushing's disease (CD). Hyperglycemia during treatment can occur because of the drug's mechanism of action, although treatment discontinuation is rarely required. The prospective, randomized, Phase IV SOM230B2219 (NCT02060383) trial was designed to assess optimal management of pasireotide-associated hyperglycemia. Here, we investigated predictive factors for requiring antihyperglycemic medication during pasireotide treatment.MethodsParticipants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks). Those who did not need antihyperglycemic medication, were managed with metformin, or received insulin from baseline entered an observational arm ending at 16 weeks. Those who required additional/alternative antihyperglycemic medication to metformin were randomized to incretin-based therapy or insulin for an additional 16 weeks. Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.ResultsOf 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication; most were aged 1c) <6.5% (<48 mmol/mol; acromegaly 98.9%, CD 100%) and fasting plasma glucose (FPG) <100 mg/dL (<5.6 mmol/L; acromegaly 76.1%, CD 100%). By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants; increasing baseline HbA1c (OR 12.6; P=0.0276) was also predictive in CD participants. Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes/pre-diabetes.ConclusionIncreasing age, HbA1c, and FPG and pre-diabetes/diabetes were associated with increased likelihood of requiring antihyperglycemic medication during pasireotide treatment. These risk factors may be used to identify those who need more vigilant monitoring to optimize outcomes during pasireotide treatment.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    During pasireotide treatment, 88 of 190 acromegaly participants did not need antihyperglycemic medication.

    In plain wordsDuring pasireotide treatment, 88 of 190 participants with acromegaly did not need medication for high blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableNo need for antihyperglycemic medication in acromegaly
    Study

    n = 190

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 mg/28 days · intramuscular · up to 16 weeks (pre-randomization)As given in this study (human).

    Measurements

    Participants not needing antihyperglycemic medication
    88 participants
    acromegaly, pre-randomization, of 190

    Source sentences

    Summary
    Of 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication;
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  2. 02HumanNon-randomized trialSafety outcome

    During pasireotide treatment, hyperglycemia-related adverse events occurred in 47.9% of acromegaly participants, mainly those with diabetes/pre-diabetes.

    In plain wordsDuring pasireotide treatment, 47.9% of participants with acromegaly had adverse events related to high blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia-related adverse events in acromegaly
    Study

    n = 190

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    40 mg/28 days · intramuscularAs given in this study (human).

    Measurements

    Hyperglycemia-related adverse events
    47.9%
    acromegaly participants, investigator-reported

    Source sentences

    Summary
    Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes/pre-diabetes.
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  3. 03HumanNon-randomized trialSafety outcome

    During pasireotide treatment, 15 of 59 Cushing's disease participants did not need antihyperglycemic medication.

    In plain wordsDuring pasireotide treatment, 15 of 59 participants with Cushing's disease did not need medication for high blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableNo need for antihyperglycemic medication in Cushing's disease
    Study

    n = 59

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600 μg twice daily · subcutaneous · up to 16 weeks (pre-randomization)As given in this study (human).

    Measurements

    Participants not needing antihyperglycemic medication
    15 participants
    Cushing's disease, pre-randomization, of 59

    Source sentences

    Summary
    Of 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication;
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  4. 04HumanNon-randomized trialSafety outcome

    During pasireotide treatment, hyperglycemia-related adverse events occurred in 54.2% of Cushing's disease participants, mainly those with diabetes/pre-diabetes.

    In plain wordsDuring pasireotide treatment, 54.2% of participants with Cushing's disease had adverse events related to high blood sugar.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia-related adverse events in Cushing's disease
    Study

    n = 59

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    600 μg twice daily · subcutaneousAs given in this study (human).

    Measurements

    Hyperglycemia-related adverse events
    54.2%
    Cushing's disease participants, investigator-reported

    Source sentences

    Summary
    Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes/pre-diabetes.
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  5. 05HumanObservational studySafety outcome

    In pasireotide-treated acromegaly participants, higher baseline HbA1c predicted antihyperglycemic medication receipt (OR 3.6, P=0.0162).

    In plain wordsIn pasireotide-treated participants with acromegaly, higher baseline HbA1c was linked to a greater need for blood sugar medication.

    Peptide
    Pasireotide
    Outcome
    IncreaseBaseline HbA1c association in acromegaly
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 mg/28 days · intramuscular · up to 16 weeks (pre-randomization)As given in this study (human).

    Measurements

    Odds ratio, baseline HbA1c, acromegaly
    3.6 odds ratio
    baseline HbA1c, acromegaly
    P value, baseline HbA1c, acromegaly
    0.0162 P
    baseline HbA1c, acromegaly

    Source sentences

    Summary
    By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants;
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  6. 06HumanObservational studySafety outcome

    In pasireotide-treated acromegaly participants, increasing baseline fasting plasma glucose predicted antihyperglycemic medication receipt (OR 1.0, P=0.0472).

    In plain wordsIn pasireotide-treated participants with acromegaly, increasing baseline fasting glucose was linked to receipt of blood sugar medication.

    Peptide
    Pasireotide
    Outcome
    IncreaseBaseline fasting glucose association in acromegaly
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 mg/28 days · intramuscular · up to 16 weeks (pre-randomization)As given in this study (human).

    Measurements

    Odds ratio, baseline FPG, acromegaly
    1 odds ratio
    baseline FPG, acromegaly
    P value, baseline FPG, acromegaly
    0.0472 P
    baseline FPG, acromegaly

    Source sentences

    Summary
    By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants;
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  7. 07HumanObservational studySafety outcome

    In pasireotide-treated acromegaly participants, diabetes/pre-diabetes history predicted antihyperglycemic medication receipt (OR 3.0, P=0.0221).

    In plain wordsIn pasireotide-treated participants with acromegaly, diabetes or pre-diabetes history was linked to a greater need for blood sugar medication.

    Peptide
    Pasireotide
    Outcome
    IncreaseDiabetes history association in acromegaly
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 mg/28 days · intramuscular · up to 16 weeks (pre-randomization)As given in this study (human).

    Measurements

    Odds ratio, diabetes/pre-diabetes history, acromegaly
    3 odds ratio
    diabetes/pre-diabetes history, acromegaly
    P value, diabetes/pre-diabetes history, acromegaly
    0.0221 P
    diabetes/pre-diabetes history, acromegaly

    Source sentences

    Summary
    By logistic regression, increasing baseline HbA1c (odds ratio [OR] 3.6; P=0.0162) and FPG (OR 1.0; P=0.0472) and history of diabetes/pre-diabetes (OR 3.0; P=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants;
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.
  8. 08HumanObservational studySafety outcome

    In pasireotide-treated Cushing's disease participants, higher baseline HbA1c predicted antihyperglycemic medication receipt (OR 12.6, P=0.0276).

    In plain wordsIn pasireotide-treated participants with Cushing's disease, higher baseline HbA1c was linked to a greater need for blood sugar medication.

    Peptide
    Pasireotide
    Outcome
    IncreaseBaseline HbA1c association in Cushing's disease
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600 μg twice daily · subcutaneous · up to 16 weeks (pre-randomization)As given in this study (human).

    Measurements

    Odds ratio, baseline HbA1c, Cushing's disease
    12.6 odds ratio
    baseline HbA1c, Cushing's disease
    P value, baseline HbA1c, Cushing's disease
    0.0276 P
    baseline HbA1c, Cushing's disease

    Source sentences

    Summary
    ; increasing baseline HbA1c (OR 12.6; P=0.0276) was also predictive in CD participants.
    2 context sentences
    Summary · context
    Participants with acromegaly or CD initiated long-acting pasireotide 40 mg/28 days intramuscularly (acromegaly) or pasireotide 600 μg subcutaneously twice daily during pre-randomization (≤16 weeks).
    Summary · context
    Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.

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 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.