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Study · Not a test of the peptide alone · 2021

10 results

A Phase 2 Evaluation of a Novel Co-Formulation of Pramlintide and Regular Insulin to Improve Postprandial Glycemic Control in Adults with Type 1 Diabetes (T1D)

Edelman S, Conoscenti V, Junaidi M, Close N, Sequeira D, Nguyen A

Journal of the Endocrine Society3 May 2021

PMCIDPMC8265936 (opens in a new tab)PepBankPUB-91323660
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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 study10

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone10

In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Pramlintide (Symlin).

  1. 01HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In adults with type 1 diabetes, XP-3924 reduced hyperglycemia exposure after glucose challenge by 62.3% versus regular insulin.

    In plain wordsIn type 1 diabetes, the insulin-pramlintide formulation reduced high glucose exposure more than regular insulin.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseHyperglycemia exposure
    Study

    n = 18

    Comparator
    Regular insulin alone
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Reduction in hyperglycemia (blood glucose AUC0-3 hr >180 mg/dL)
    62.3%
    XP-3924 versus regular insulin, p<0.001

    Source sentences

    Summary
    XP-3924 treatment resulted in a 62.3% reduction of hyperglycemia (blood glucose AUC0-3 hr >180 mg/dL) after the glucose challenge when compared to RI (p<0.001), and exhibited comparable postprandial glycemic control to that of the co-administration.
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  2. 02HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In adults with type 1 diabetes, XP-3924 produced comparable postprandial glycemic control to separate insulin and pramlintide administration.

    In plain wordsIn type 1 diabetes, the insulin-pramlintide formulation and separate insulin-pramlintide injections produced comparable glucose control after meals.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changePostprandial glycemic control
    Study

    n = 18

    Comparator
    Separate regular insulin and pramlintide
    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    XP-3924 treatment resulted in a 62.3% reduction of hyperglycemia (blood glucose AUC0-3 hr >180 mg/dL) after the glucose challenge when compared to RI (p<0.001), and exhibited comparable postprandial glycemic control to that of the co-administration.
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  3. 03HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In adults with type 1 diabetes, XP-3924 produced less mean absolute glucose change than separate insulin and pramlintide administration.

    In plain wordsIn type 1 diabetes, the insulin-pramlintide formulation produced smaller glucose changes than separate insulin-pramlintide injections.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseMean absolute glucose change versus co-administration
    Study

    n = 18

    Comparator
    Separate regular insulin and pramlintide
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Mean absolute change in blood glucose
    197.7 mg/dL
    XP-3924
    Mean absolute change in blood glucose
    230.5 mg/dL
    Co-administration of regular insulin and pramlintide

    Source sentences

    Summary
    After the oral glucose challenge, the mean absolute change in blood glucose and was less in XP-3924 when compared to both co-administration and to RI (197.7±70.74 mg/dL, 230.5±162.39 mg/dL, 254.2±195.21 mg/dL, respectively),
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  4. 04HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In adults with type 1 diabetes, XP-3924 produced less mean absolute glucose change than regular insulin alone.

    In plain wordsIn type 1 diabetes, the insulin-pramlintide formulation produced smaller glucose changes than regular insulin alone.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseMean absolute glucose change versus insulin
    Study

    n = 18

    Comparator
    Regular insulin alone
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Mean absolute change in blood glucose
    197.7 mg/dL
    XP-3924
    Mean absolute change in blood glucose
    254.2 mg/dL
    Regular insulin alone

    Source sentences

    Summary
    After the oral glucose challenge, the mean absolute change in blood glucose and was less in XP-3924 when compared to both co-administration and to RI (197.7±70.74 mg/dL, 230.5±162.39 mg/dL, 254.2±195.21 mg/dL, respectively),
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  5. 05HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In adults with type 1 diabetes, XP-3924 produced lower glucose variability than separate insulin and pramlintide administration.

    In plain wordsIn type 1 diabetes, the insulin-pramlintide formulation produced less glucose variability than separate insulin-pramlintide injections.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseGlucose variability versus co-administration
    Study

    n = 18

    Comparator
    Separate regular insulin and pramlintide
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Intrasubject coefficient of variation of plasma glucose
    53.3%
    XP-3924
    Intrasubject coefficient of variation of plasma glucose
    62.1%
    Co-administration of regular insulin and pramlintide

    Source sentences

    Summary
    as well as GV as defined by the comparison of the intrasubject coefficient of variation of plasma glucose readings across study treatments (53.3%, 62.1%, 71.0%, respectively).
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  6. 06HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In adults with type 1 diabetes, XP-3924 produced lower glucose variability than regular insulin alone.

    In plain wordsIn type 1 diabetes, the insulin-pramlintide formulation produced less glucose variability than regular insulin alone.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseGlucose variability versus insulin
    Study

    n = 18

    Comparator
    Regular insulin alone
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Intrasubject coefficient of variation of plasma glucose
    53.3%
    XP-3924
    Intrasubject coefficient of variation of plasma glucose
    71%
    Regular insulin alone

    Source sentences

    Summary
    as well as GV as defined by the comparison of the intrasubject coefficient of variation of plasma glucose readings across study treatments (53.3%, 62.1%, 71.0%, respectively).
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  7. 07HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialPharmacokinetics

    In adults with type 1 diabetes, pramlintide had a longer median Tmax in XP-3924 than with separate insulin-pramlintide administration.

    In plain wordsIn type 1 diabetes, pramlintide reached peak exposure later in the formulation than with separate insulin-pramlintide injections.

    Peptide
    Pramlintide (Symlin)
    Outcome
    IncreasePramlintide Tmax
    Study

    n = 18

    Comparator
    Separate regular insulin and pramlintide
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Pramlintide median Tmax
    40.5 min
    XP-3924, range 21.0-150.0
    Pramlintide median Tmax
    10 min
    Co-administration, range 10.0-24.0

    Source sentences

    Summary
    The PK of Pramlintide in XP-3924 when compared to co-administration, exhibited longer median Tmax [40.5 (range 21.0–150.0) minutes versus 10.0 (range 10.0–24.0) minutes, respectively], and comparable AUC0-360.
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  8. 08HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialPharmacokinetics

    In adults with type 1 diabetes, pramlintide exposure was comparable with XP-3924 and separate insulin-pramlintide administration.

    In plain wordsIn type 1 diabetes, pramlintide exposure was comparable between the formulation and separate insulin-pramlintide injections.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changePramlintide AUC
    Study

    n = 18

    Comparator
    Separate regular insulin and pramlintide
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    The PK of Pramlintide in XP-3924 when compared to co-administration, exhibited longer median Tmax [40.5 (range 21.0–150.0) minutes versus 10.0 (range 10.0–24.0) minutes, respectively], and comparable AUC0-360.
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  9. 09HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome

    In adults with type 1 diabetes, adverse event incidence and severity were comparable across arms, including injection reactions, minimal nausea and vomiting.

    In plain wordsIn type 1 diabetes, adverse event frequency and severity were comparable across the formulation, separate injections, and insulin arms.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeTreatment-emergent adverse events
    Study

    n = 18

    Comparator
    All treatment arms
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    The incidence and severity of treatment emergent adverse events (e.g., injection site reactions, minimal nausea and vomiting) was comparable across all treatment arms with no drug-related serious adverse events.
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

  10. 10HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome

    In adults with type 1 diabetes, no drug-related serious adverse events occurred across treatment arms.

    In plain wordsIn type 1 diabetes, no drug-related serious adverse events occurred across treatment arms.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeDrug-related serious adverse events
    Study

    n = 18

    Comparator
    All treatment arms
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    The incidence and severity of treatment emergent adverse events (e.g., injection site reactions, minimal nausea and vomiting) was comparable across all treatment arms with no drug-related serious adverse events.
    1 context sentence
    Summary · context
    This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and praml…

    In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).

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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