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Study · Randomized controlled trial · n = 45 · 2013

11 results

Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers.

Henry RR, Ciaraldi TP, Armstrong D, Burke P, Ligueros-Saylan M, Mudaliar S

The Journal of clinical endocrinology and metabolism3 Jun 2013Cited by 200 (Europe PMC)

PMID23733372 (opens in a new tab)DOI10.1210/jc.2013-1771 (opens in a new tab)PepBankPUB-23733372
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialOther

    In healthy men receiving pasireotide, no dose dependency was observed.

    In plain wordsIn healthy men, pasireotide results showed no dose dependency.

    Peptide
    Pasireotide
    Outcome
    Not applicableDose dependency
    Study

    n: not reported in source

    Comparator
    pasireotide dose groups (600, 900, 1200 μg twice a day)
    Outcome group
    Receptor activity and mechanism · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No dose dependency or unexpected adverse events were observed.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  2. 02HumanNon-randomized trialMechanism

    In healthy men, pasireotide reduced insulin AUC0-180 min by 77.5% during the hyperglycemic clamp, P < .001 in both dose groups.

    In plain wordsIn healthy men, insulin exposure during the clamp decreased after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreaseInsulin AUC during hyperglycemic clamp
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Change in insulin AUC0-180 min during hyperglycemic clamp
    −77.5%
    P < .001 in both dose groups

    Source sentences

    Summary
    Pasireotide treatment resulted in significant decreases in insulin AUC0-180 min during both the hyperglycemic clamp test (-77.5%; P < .001 in both dose groups) and the OGTT (-61.9%; P < .001 in both dose groups).
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  3. 03HumanNon-randomized trialMechanism

    In healthy men, hepatic insulin sensitivity did not change significantly after pasireotide.

    In plain wordsIn healthy men, liver insulin sensitivity did not change significantly after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    No significant changeHepatic insulin sensitivity
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No significant changes in hepatic or peripheral insulin sensitivity were found during the hyperinsulinemic-euglycemic clamp test.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  4. 04HumanNon-randomized trialMechanism

    In healthy men, peripheral insulin sensitivity did not change significantly after pasireotide.

    In plain wordsIn healthy men, peripheral insulin sensitivity did not change significantly after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    No significant changePeripheral insulin sensitivity
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No significant changes in hepatic or peripheral insulin sensitivity were found during the hyperinsulinemic-euglycemic clamp test.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide, no unexpected adverse events occurred.

    In plain wordsHealthy men receiving pasireotide had no unexpected side effects.

    Peptide
    Pasireotide
    Outcome
    Not applicableUnexpected adverse events
    Study

    n = 45

    Outcome group
    Adverse events · Whole body
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No dose dependency or unexpected adverse events were observed.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy men, increased gastrointestinal adverse event severity led to discontinuation of randomization to pasireotide 1200 μg.

    In plain wordsIn healthy men, greater digestive side effect severity stopped assignment to the highest pasireotide dose.

    Peptide
    Pasireotide
    Outcome
    IncreaseGastrointestinal adverse event severity
    Study

    n = 7

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1200 μg twice a day · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Randomization to 1200 μg was discontinued because of increased severity of gastrointestinal adverse events in this arm.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  7. 07HumanNon-randomized trialMechanism

    In healthy men, pasireotide reduced insulin AUC0-180 min by 61.9% during OGTT, P < .001 in both dose groups.

    In plain wordsIn healthy men, insulin exposure during the oral glucose test decreased after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreaseInsulin AUC during OGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Change in insulin AUC0-180 min during OGTT
    −61.9%
    P < .001 in both dose groups

    Source sentences

    Summary
    Pasireotide treatment resulted in significant decreases in insulin AUC0-180 min during both the hyperglycemic clamp test (-77.5%; P < .001 in both dose groups) and the OGTT (-61.9%; P < .001 in both dose groups).
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  8. 08HumanNon-randomized trialMechanism

    In healthy men, pasireotide suppressed glucagon less markedly than insulin.

    In plain wordsIn healthy men, pasireotide suppressed glucagon less than insulin.

    Peptide
    Pasireotide
    Outcome
    DecreaseGlucagon levels
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Suppression of glucagon levels was less pronounced.
    3 context sentences
    Summary · context
    Pasireotide treatment resulted in significant decreases in insulin AUC0-180 min during both the hyperglycemic clamp test (-77.5%; P < .001 in both dose groups) and the OGTT (-61.9%; P < .001 in both dose groups).
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  9. 09HumanNon-randomized trialSafety outcome

    In healthy men, pasireotide significantly increased OGTT glucose AUC by 67.4%.

    In plain wordsIn healthy men, blood sugar exposure during the oral glucose test increased after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    IncreaseGlucose AUC during OGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Glucose AUC0-180 min change
    67.4%
    OGTT, pasireotide treatment versus baseline, healthy men

    Source sentences

    Summary
    Additionally, significant increases in glucose AUC₀₋₁₈₀ min (+67.4%) and decreases in AUC₀₋₁₈₀ min glucagon-like peptide-1 (-46.7%) and glucose-dependent insulinotropic polypeptide levels (-69.8%) were observed during the OGTT.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  10. 10HumanNon-randomized trialMechanism

    In healthy men, pasireotide significantly decreased GLP-1 AUC by 46.7% during OGTT.

    In plain wordsIn healthy men, GLP-1 exposure during the oral glucose test decreased after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreaseGLP-1 AUC during OGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    GLP-1 AUC0-180 min change
    −46.7%
    OGTT, pasireotide treatment versus baseline, healthy men

    Source sentences

    Summary
    Additionally, significant increases in glucose AUC₀₋₁₈₀ min (+67.4%) and decreases in AUC₀₋₁₈₀ min glucagon-like peptide-1 (-46.7%) and glucose-dependent insulinotropic polypeptide levels (-69.8%) were observed during the OGTT.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.
  11. 11HumanNon-randomized trialMechanism

    In healthy men, pasireotide significantly decreased glucose-dependent insulinotropic polypeptide levels by 69.8% during OGTT.

    In plain wordsIn healthy men, GIP levels during the oral glucose test decreased after pasireotide compared with baseline.

    Peptide
    Pasireotide
    Outcome
    DecreaseGIP levels during OGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600, 900, or 1200 μg twice a day across study arms · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    GIP AUC0-180 min change
    −69.8%
    OGTT, pasireotide treatment versus baseline, healthy men

    Source sentences

    Summary
    Additionally, significant increases in glucose AUC₀₋₁₈₀ min (+67.4%) and decreases in AUC₀₋₁₈₀ min glucagon-like peptide-1 (-46.7%) and glucose-dependent insulinotropic polypeptide levels (-69.8%) were observed during the OGTT.
    2 context sentences
    Summary · context
    Forty-five healthy male volunteers were randomized to pasireotide 600 (n = 19), 900 (n = 19), or 1200 μg (n = 7) sc twice a day for 7 days.
    Summary · context
    An oral glucose tolerance test (OGTT), a hyperglycemic clamp test, and a hyperinsulinemic-euglycemic clamp test were performed on 3 consecutive days at baseline and treatment end.

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 2Results postedNCT01128192

Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers

Robert R. Henry, MDn = 45Aug 2009 to Apr 2010

Hyperglycemia

Trial pageClinicalTrials.govUpdated 25 Dec 2014

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.

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