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Study · Randomized controlled trial · 2003

6 results

Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial.

Hollander PA, Levy P, Fineman MS, Maggs DG, Shen LZ, Strobel SA, Weyer C, Kolterman OG

Diabetes care1 Mar 2003Cited by 225 (Europe PMC)

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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, pramlintide reduced HbA1c by 0.68% at week 26, significantly more than placebo.

    In plain wordsIn type 2 diabetes, pramlintide reduced HbA1c more than placebo at week 26.

    Outcome
    DecreaseHbA1c at week 26
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    120 microg BID · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −0.68%
    pramlintide 120 microg BID, week 26

    Source sentences

    Summary
    Treatment with pramlintide 120 micro g BID led to a sustained reduction from baseline in HbA(1c) (-0.68 and -0.62% at weeks 26 and 52, respectively), which was significantly greater than that seen with placebo (P < 0.05).
    1 context sentence
    Summary · context
    In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 +/- 10 years, diabetes duration 12 +/- 7 years, BMI 34.0 +/- 7.0 kg/m(2), HbA(1c) 9.1 +/- 1.2%, mean +/- SD) treated with insulin (alone or in combination with sulfonylureas a…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, pramlintide reduced HbA1c by 0.62% at week 52, significantly more than placebo.

    In plain wordsIn type 2 diabetes, pramlintide reduced HbA1c more than placebo at week 52.

    Outcome
    DecreaseHbA1c at week 52
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    120 microg BID · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    HbA1c change from baseline
    −0.62%
    pramlintide 120 microg BID, week 52

    Source sentences

    Summary
    Treatment with pramlintide 120 micro g BID led to a sustained reduction from baseline in HbA(1c) (-0.68 and -0.62% at weeks 26 and 52, respectively), which was significantly greater than that seen with placebo (P < 0.05).
    1 context sentence
    Summary · context
    In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 +/- 10 years, diabetes duration 12 +/- 7 years, BMI 34.0 +/- 7.0 kg/m(2), HbA(1c) 9.1 +/- 1.2%, mean +/- SD) treated with insulin (alone or in combination with sulfonylureas a…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, 46% receiving pramlintide achieved HbA1c below 8%, versus 28% receiving placebo.

    In plain wordsIn type 2 diabetes, more pramlintide recipients than placebo recipients achieved HbA1c below 8%.

    Outcome
    IncreaseHbA1c below 8%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    120 microg BID · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Patients with HbA1c <8%
    46%
    pramlintide 120 microg BID, week 52
    Patients with HbA1c <8%
    28%
    placebo, week 52

    Source sentences

    Summary
    The proportion of patients achieving an HbA(1c) <8% was approximately twofold greater with pramlintide (120 microg BID) than with placebo (46 vs. 28%, P < 0.05).
    1 context sentence
    Summary · context
    In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 +/- 10 years, diabetes duration 12 +/- 7 years, BMI 34.0 +/- 7.0 kg/m(2), HbA(1c) 9.1 +/- 1.2%, mean +/- SD) treated with insulin (alone or in combination with sulfonylureas a…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In type 2 diabetes, weight decreased by 1.4 kg with pramlintide versus a 0.7 kg gain with placebo.

    In plain wordsIn type 2 diabetes, weight decreased with pramlintide and increased with placebo.

    Outcome
    DecreaseBody weight
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120 microg BID · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Body weight change at week 52
    −1.4 kg
    pramlintide 120 microg BID
    Body weight change at week 52
    0.7 kg
    placebo

    Source sentences

    Summary
    The glycemic improvement with pramlintide 120 micro g BID was accompanied by a mean weight loss (-1.4 kg vs. +0.7 kg with placebo at week 52, P < 0.05) and occurred without an overall increase in the severe hypoglycemia event rate.
    1 context sentence
    Summary · context
    In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 +/- 10 years, diabetes duration 12 +/- 7 years, BMI 34.0 +/- 7.0 kg/m(2), HbA(1c) 9.1 +/- 1.2%, mean +/- SD) treated with insulin (alone or in combination with sulfonylureas a…
  5. 05HumanRandomized controlled trialSafety outcome

    In type 2 diabetes, pramlintide did not increase the overall severe hypoglycemia event rate.

    In plain wordsIn type 2 diabetes, pramlintide did not increase the overall rate of severe low blood sugar events.

    Outcome
    No significant changeSevere hypoglycemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    120 microg BID · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The glycemic improvement with pramlintide 120 micro g BID was accompanied by a mean weight loss (-1.4 kg vs. +0.7 kg with placebo at week 52, P < 0.05) and occurred without an overall increase in the severe hypoglycemia event rate.
    1 context sentence
    Summary · context
    In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 +/- 10 years, diabetes duration 12 +/- 7 years, BMI 34.0 +/- 7.0 kg/m(2), HbA(1c) 9.1 +/- 1.2%, mean +/- SD) treated with insulin (alone or in combination with sulfonylureas a…
  6. 06HumanRandomized controlled trialSafety outcome

    In type 2 diabetes, transient mild-to-moderate nausea was the most common adverse event associated with pramlintide.

    In plain wordsIn type 2 diabetes, temporary mild-to-moderate nausea was the most common adverse event associated with pramlintide.

    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common adverse event associated with pramlintide use was transient, mild-to-moderate nausea.
    1 context sentence
    Summary · context
    In a 52-week, double-blind, placebo-controlled, parallel-group, multicenter study, 656 patients with type 2 diabetes (age 57 +/- 10 years, diabetes duration 12 +/- 7 years, BMI 34.0 +/- 7.0 kg/m(2), HbA(1c) 9.1 +/- 1.2%, mean +/- SD) treated with insulin (alone or in combination with sulfonylureas a…

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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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