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Study · Non-randomized trial · 2016

5 results

Effect of pasireotide on glucose- and growth hormone-related biomarkers in patients with inadequately controlled acromegaly.

Schmid HA, Brue T, Colao A, Gadelha MR, Shimon I, Kapur K, Pedroncelli AM, Fleseriu M

Endocrine23 Feb 2016Cited by 60 (Europe PMC)

PMID26906713 (opens in a new tab)PMCIDPMC4901125 (opens in a new tab)DOI10.1007/s12020-016-0895-8 (opens in a new tab)PepBankPUB-26906713
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Summary

The purpose of this study was to gain more insight into the mechanism of action of pasireotide in patients who completed the PAOLA study. PAOLA was a 24-week, Phase III, randomized, three-arm study of pasireotide LAR 40 and 60 mg versus octreotide LAR 30 mg or lanreotide Autogel 120 mg in patients with inadequately controlled acromegaly. The current work was a planned exploratory objective of the PAOLA study that evaluated changes in levels of growth hormone (GH), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP-2, IGFBP-3), glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in each treatment arm. Responders to pasireotide LAR (mean GH levels <2.5 μg/L and normal IGF-1 levels at 24 weeks) had lower GH and IGF-1 levels at baseline (GH 5.1 ng/mL, IGF-1 519 ng/mL) than non-responders (GH 7.9 ng/mL, IGF-1 672 ng/mL). Frequency of hyperglycaemia after pasireotide treatment was similar in responders and non-responders and depended more on the baseline FPG level. 47 % of all patients treated with pasireotide LAR (40 or 60 mg) did not receive antidiabetic medication at any time during this study. This is the first study to evaluate the treatment effect of pasireotide on key hormonal and glycaemic biomarkers and to identify potential predictors of pasireotide-associated hyperglycaemia. Pre-treatment glucose status may be predictive of the development of pasireotide-associated hyperglycaemia. A large subset of patients with acromegaly does not experience major disturbances in glucose homeostasis while receiving pasireotide LAR.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanNon-randomized trialOther

    In acromegaly patients receiving pasireotide LAR, 47% used no antidiabetic medication at any time during the study.

    In plain wordsAmong pasireotide recipients, 47% did not receive diabetes medication during the study.

    Peptide
    Pasireotide
    Outcome
    Not applicableAbsence of antidiabetic medication use
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 or 60 mg · 24 weeksAs given in this study (human).

    Measurements

    Patients without antidiabetic medication
    47%
    all patients treated with pasireotide LAR 40 or 60 mg

    Source sentences

    Summary
    47 % of all patients treated with pasireotide LAR (40 or 60 mg) did not receive antidiabetic medication at any time during this study.
    2 context sentences
    Summary · context
    PAOLA was a 24-week, Phase III, randomized, three-arm study of pasireotide LAR 40 and 60 mg versus octreotide LAR 30 mg or lanreotide Autogel 120 mg in patients with inadequately controlled acromegaly.
    Summary · context
    The current work was a planned exploratory objective of the PAOLA study that evaluated changes in levels of growth hormone (GH), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP-2, IGFBP-3), glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in each treatment arm.
  2. 02HumanObservational studyOther

    In acromegaly patients receiving pasireotide, responders had lower baseline GH than nonresponders (5.1 versus 7.9 ng/mL).

    In plain wordsIn pasireotide recipients, lower baseline growth hormone was linked to treatment response.

    Peptide
    Pasireotide
    Outcome
    DecreaseBaseline GH by response
    Study

    n: not reported in source

    Comparator
    Pasireotide nonresponders
    Analysis
    Exploratory
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 or 60 mg · 24 weeksAs given in this study (human).

    Measurements

    Baseline GH
    5.1 ng/mL
    pasireotide LAR responders
    Baseline GH
    7.9 ng/mL
    pasireotide LAR non-responders

    Source sentences

    Summary
    Responders to pasireotide LAR (mean GH levels <2.5 μg/L and normal IGF-1 levels at 24 weeks) had lower GH and IGF-1 levels at baseline (GH 5.1 ng/mL, IGF-1 519 ng/mL) than non-responders (GH 7.9 ng/mL, IGF-1 672 ng/mL).
    2 context sentences
    Summary · context
    PAOLA was a 24-week, Phase III, randomized, three-arm study of pasireotide LAR 40 and 60 mg versus octreotide LAR 30 mg or lanreotide Autogel 120 mg in patients with inadequately controlled acromegaly.
    Summary · context
    The current work was a planned exploratory objective of the PAOLA study that evaluated changes in levels of growth hormone (GH), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP-2, IGFBP-3), glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in each treatment arm.
  3. 03HumanObservational studyOther

    In acromegaly patients receiving pasireotide, responders had lower baseline IGF-1 than nonresponders (519 versus 672 ng/mL).

    In plain wordsIn pasireotide recipients, lower baseline IGF-1 was linked to treatment response.

    Peptide
    Pasireotide
    Outcome
    DecreaseBaseline IGF-1 by response
    Study

    n: not reported in source

    Comparator
    Pasireotide nonresponders
    Analysis
    Exploratory
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 or 60 mg · 24 weeksAs given in this study (human).

    Measurements

    Baseline IGF-1
    519 ng/mL
    pasireotide LAR responders
    Baseline IGF-1
    672 ng/mL
    pasireotide LAR non-responders

    Source sentences

    Summary
    Responders to pasireotide LAR (mean GH levels <2.5 μg/L and normal IGF-1 levels at 24 weeks) had lower GH and IGF-1 levels at baseline (GH 5.1 ng/mL, IGF-1 519 ng/mL) than non-responders (GH 7.9 ng/mL, IGF-1 672 ng/mL).
    2 context sentences
    Summary · context
    PAOLA was a 24-week, Phase III, randomized, three-arm study of pasireotide LAR 40 and 60 mg versus octreotide LAR 30 mg or lanreotide Autogel 120 mg in patients with inadequately controlled acromegaly.
    Summary · context
    The current work was a planned exploratory objective of the PAOLA study that evaluated changes in levels of growth hormone (GH), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP-2, IGFBP-3), glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in each treatment arm.
  4. 04HumanObservational studySafety outcome

    In acromegaly patients receiving pasireotide, hyperglycemia frequency was similar in responders and nonresponders.

    In plain wordsHigh blood sugar occurred similarly in pasireotide responders and nonresponders.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedHyperglycemia by response
    Study

    n: not reported in source

    Comparator
    Pasireotide nonresponders
    Analysis
    Exploratory
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    40 or 60 mg · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Frequency of hyperglycaemia after pasireotide treatment was similar in responders and non-responders and depended more on the baseline FPG level.
    2 context sentences
    Summary · context
    PAOLA was a 24-week, Phase III, randomized, three-arm study of pasireotide LAR 40 and 60 mg versus octreotide LAR 30 mg or lanreotide Autogel 120 mg in patients with inadequately controlled acromegaly.
    Summary · context
    The current work was a planned exploratory objective of the PAOLA study that evaluated changes in levels of growth hormone (GH), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP-2, IGFBP-3), glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in each treatment arm.
  5. 05HumanObservational studySafety outcome

    In acromegaly patients receiving pasireotide, hyperglycemia frequency depended more on baseline fasting plasma glucose than on treatment response.

    In plain wordsIn pasireotide recipients, high blood sugar was linked more to baseline fasting glucose than to treatment response.

    Peptide
    Pasireotide
    Outcome
    Not applicableHyperglycemia association with baseline FPG
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 or 60 mg · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Frequency of hyperglycaemia after pasireotide treatment was similar in responders and non-responders and depended more on the baseline FPG level.
    2 context sentences
    Summary · context
    PAOLA was a 24-week, Phase III, randomized, three-arm study of pasireotide LAR 40 and 60 mg versus octreotide LAR 30 mg or lanreotide Autogel 120 mg in patients with inadequately controlled acromegaly.
    Summary · context
    The current work was a planned exploratory objective of the PAOLA study that evaluated changes in levels of growth hormone (GH), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP-2, IGFBP-3), glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in each treatment arm.

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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