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Study · Non-randomized trial · n = 477 · 2005

3 results

Adjunctive therapy with pramlintide lowers HbA1c without concomitant weight gain and increased risk of severe hypoglycemia in patients with type 1 diabetes approaching glycemic targets.

Ratner R, Whitehouse F, Fineman MS, Strobel S, Shen L, Maggs DG, Kolterman OG, Weyer C

Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association1 Apr 2005Cited by 41 (Europe PMC)

PMID15891954 (opens in a new tab)DOI10.1055/s-2005-837662 (opens in a new tab)PepBankPUB-15891954
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In type 1 diabetes patients approaching glycemic targets, adjunctive pramlintide reduced HbA1c compared with placebo.

    In plain wordsIn type 1 diabetes patients near glucose targets, pramlintide reduced HbA1c more than placebo.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseHbA1c
    Study

    n = 477

    Comparator
    Placebo plus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Placebo-corrected HbA1c reduction
    0.3%
    week 26

    Source sentences

    Summary
    Adjunctive therapy with pramlintide resulted in significant reductions in HbA1c and body weight from baseline to week 26 (0.3 % and 1.8 kg, placebo-corrected treatment differences, respectively, both p<or=0.0009).
    3 context sentences
    Summary · context
    To address this question, we conducted a pooled analysis from 3 long-term clinical trials, including all patients with an entry HbA1c between 7.0 % and 8.5 %.
    Summary · context
    Within the subset of patients with an entry HbA1c between 7.0 % and 8.5 % (approximately 28 % of all patients enrolled in the 3 studies), 196 were treated with placebo + insulin (baseline HbA1c 7.9+/-0.4 %, body weight 76.0+/-14.3 kg [mean+/-SD]) and 281 with pramlintide+insulin (baseline HbA1c 7.9+…
    Summary · context
    Endpoints included placebo-corrected changes from baseline to week 26 in HbA1c, body weight, and the event rate of severe hypoglycemia.
  2. 02HumanNon-randomized trialEfficacy outcome

    In type 1 diabetes patients approaching glycemic targets, adjunctive pramlintide reduced weight compared with placebo.

    In plain wordsIn type 1 diabetes patients near glucose targets, pramlintide reduced weight more than placebo.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseBody weight
    Study

    n = 477

    Comparator
    Placebo plus insulin
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Placebo-corrected weight reduction
    1.8 kg
    week 26

    Source sentences

    Summary
    Adjunctive therapy with pramlintide resulted in significant reductions in HbA1c and body weight from baseline to week 26 (0.3 % and 1.8 kg, placebo-corrected treatment differences, respectively, both p<or=0.0009).
    3 context sentences
    Summary · context
    To address this question, we conducted a pooled analysis from 3 long-term clinical trials, including all patients with an entry HbA1c between 7.0 % and 8.5 %.
    Summary · context
    Within the subset of patients with an entry HbA1c between 7.0 % and 8.5 % (approximately 28 % of all patients enrolled in the 3 studies), 196 were treated with placebo + insulin (baseline HbA1c 7.9+/-0.4 %, body weight 76.0+/-14.3 kg [mean+/-SD]) and 281 with pramlintide+insulin (baseline HbA1c 7.9+…
    Summary · context
    Endpoints included placebo-corrected changes from baseline to week 26 in HbA1c, body weight, and the event rate of severe hypoglycemia.
  3. 03HumanNon-randomized trialSafety outcome

    In type 1 diabetes patients approaching glycemic targets, pramlintide did not increase overall severe hypoglycemia risk compared with placebo.

    In plain wordsIn type 1 diabetes patients near glucose targets, pramlintide did not increase severe low blood sugar risk compared with placebo.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeSevere hypoglycemia
    Study

    n = 477

    Comparator
    Placebo plus insulin
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Measurements

    Severe hypoglycemia rate
    1.4 events/patient-year of exposure
    pramlintide
    Severe hypoglycemia rate
    1.86 events/patient-year of exposure
    placebo

    Source sentences

    Summary
    These changes occurred without an increase in the overall risk of severe hypoglycemia (1.40 pramlintide vs. 1.86 placebo, events/patient-year of exposure).
    3 context sentences
    Summary · context
    To address this question, we conducted a pooled analysis from 3 long-term clinical trials, including all patients with an entry HbA1c between 7.0 % and 8.5 %.
    Summary · context
    Within the subset of patients with an entry HbA1c between 7.0 % and 8.5 % (approximately 28 % of all patients enrolled in the 3 studies), 196 were treated with placebo + insulin (baseline HbA1c 7.9+/-0.4 %, body weight 76.0+/-14.3 kg [mean+/-SD]) and 281 with pramlintide+insulin (baseline HbA1c 7.9+…
    Summary · context
    Endpoints included placebo-corrected changes from baseline to week 26 in HbA1c, body weight, and the event rate of severe hypoglycemia.

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 stopped early · source ClinicalTrials.gov (opens in a new tab)

WithdrawnEarly phase 1NCT04133922

Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes

University of Virginian = 014 Oct 2019 to est. Oct 2024

Type 1 Diabetes · Insulin Sensitivity/Resistance

Trial pageClinicalTrials.govUpdated 22 Mar 2022

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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