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Study · Non-randomized trial · 2014

8 results

Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained glycemic control and weight loss for 48 weeks in metformin-treated subjects with type 2 diabetes.

Henry RR, Rosenstock J, Logan D, Alessi T, Luskey K, Baron MA

Journal of diabetes and its complications7 Jan 2014Cited by 59 (Europe PMC)

PMID24631129 (opens in a new tab)DOI10.1016/j.jdiacomp.2013.12.009 (opens in a new tab)PepBankPUB-24631129
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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

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

  1. 01HumanNon-randomized trialEfficacy outcome

    In metformin-treated type 2 diabetes, ITCA 650 exenatide reduced HbA1c from baseline by 0.85% to 1.51% at week 48.

    In plain wordsITCA 650 exenatide lowered HbA1c from baseline in patients with type 2 diabetes taking metformin.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    20, 40, 60 or 80 μg/day · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.51 to −0.85%
    baseline to week 48

    Source sentences

    Summary
    Mean changes in HbA1c from baseline to week 48 ranged from -0.85% to -1.51%.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  2. 02HumanNon-randomized trialEfficacy outcome

    At week 48, at least 64% of ITCA 650 recipients meeting the week 24 HbA1c target maintained it.

    In plain wordsAt least 64% of patients meeting the earlier HbA1c target maintained it with ITCA 650 exenatide.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableMaintained HbA1c target
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Measurements

    Subjects maintaining HbA1c <=7% at week 48
    ≥ 64%
    subjects with HbA1c <=7% at week 24

    Source sentences

    Summary
    At week 48, ≥64% of subjects with an HbA1c ≤7% at week 24 maintained an HbA1c ≤7%.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  3. 03HumanNon-randomized trialSafety outcome

    In type 2 diabetes, adverse event incidence with ITCA 650 exenatide was 13.3% at 20 μg/day.

    In plain wordsAdverse events occurred in 13.3% of patients receiving ITCA 650 exenatide at the lowest reported dose.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableAdverse events at 20 μg/day
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg/day · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Measurements

    Adverse event incidence
    13.3%
    20 μg/day

    Source sentences

    Summary
    The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 μg/day to 37.5% with 80 μg/day.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  4. 04HumanNon-randomized trialSafety outcome

    In type 2 diabetes, adverse event incidence with ITCA 650 exenatide was 37.5% at 80 μg/day.

    In plain wordsAdverse events occurred in 37.5% of patients receiving ITCA 650 exenatide at the highest reported dose.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableAdverse events at 80 μg/day
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    80 μg/day · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Measurements

    Adverse event incidence
    37.5%
    80 μg/day

    Source sentences

    Summary
    The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 μg/day to 37.5% with 80 μg/day.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  5. 05HumanNon-randomized trialSafety outcome

    In type 2 diabetes, most adverse events during ITCA 650 exenatide treatment were mild and transient.

    In plain wordsMost adverse events during ITCA 650 exenatide treatment were mild and temporary.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Most AEs were mild and transient;
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  6. 06HumanNon-randomized trialSafety outcome

    During the extension, nausea incidence with ITCA 650 exenatide declined from 12.9% to 9.5%.

    In plain wordsNausea became less frequent during continued ITCA 650 exenatide treatment.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseNausea incidence
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Measurements

    Nausea incidence
    12.9%
    start of the 24-week extension (initial treatment phase)
    Nausea incidence
    9.5%
    over the 24-week extension

    Source sentences

    Summary
    Most AEs were mild and transient; the incidence of nausea declined from 12.9% to 9.5% over the 24-week extension.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  7. 07HumanNon-randomized trialSafety outcome

    One patient receiving ITCA 650 exenatide at 80 μg/day experienced mild intermittent vomiting.

    In plain wordsOne patient receiving the highest ITCA 650 exenatide dose had mild intermittent vomiting.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableVomiting
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    80 μg/day · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    One subject on ITCA 650 80 μg/day experienced mild intermittent vomiting.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).
  8. 08HumanNon-randomized trialSafety outcome

    Three ITCA 650 exenatide recipients experienced severe adverse events, none considered related to the study drug.

    In plain wordsThree patients had severe adverse events, which investigators did not consider related to ITCA 650 exenatide.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableSevere adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · continuous subcutaneous delivery · 48 weeksAs given in this study (human).

    Measurements

    Severe adverse events
    3.5%
    ITCA 650

    Source sentences

    Summary
    Three (3.5%) subjects experienced severe AEs, but none were considered related to study drug.
    2 context sentences
    Summary · context
    This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin.
    Summary · context
    Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day).

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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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