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Study · Randomized controlled trial · 2002

8 results

Adjunctive therapy with the amylin analogue pramlintide leads to a combined improvement in glycemic and weight control in insulin-treated subjects with type 2 diabetes.

Ratner RE, Want LL, Fineman MS, Velte MJ, Ruggles JA, Gottlieb A, Weyer C, Kolterman OG

Diabetes technology & therapeutics1 Jan 2002Cited by 115 (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 study8

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In insulin-treated type 2 diabetes, pramlintide at 75 microg reduced HbA1c by 0.9%, significantly more than placebo.

    In plain wordsIn insulin-treated type 2 diabetes, intermediate-dose pramlintide reduced HbA1c more than placebo.

    Outcome
    DecreaseHbA1c at week 13, intermediate dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    75 microg TID · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    HbA1c reduction from baseline at week 13
    0.9%
    pramlintide 75 microg TID

    Source sentences

    Summary
    Pramlintide therapy led to a mean reduction in HbA1c of 0.9% and 1.0% from baseline to week 13 in the 75- and 150-microg dose groups, which was significant compared to placebo (p = 0.0004 and p = 0.0002, respectively).
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In insulin-treated type 2 diabetes, pramlintide at 150 microg reduced HbA1c by 1.0%, significantly more than placebo.

    In plain wordsIn insulin-treated type 2 diabetes, high-dose pramlintide reduced HbA1c more than placebo at week 13.

    Outcome
    DecreaseHbA1c at week 13, high dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    150 microg TID · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    HbA1c reduction from baseline at week 13
    1%
    pramlintide 150 microg TID

    Source sentences

    Summary
    Pramlintide therapy led to a mean reduction in HbA1c of 0.9% and 1.0% from baseline to week 13 in the 75- and 150-microg dose groups, which was significant compared to placebo (p = 0.0004 and p = 0.0002, respectively).
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In insulin-treated type 2 diabetes, pramlintide at 150 microg TID gave a mean HbA1c reduction of 0.6% from baseline to week 52, significant versus placebo.

    In plain wordsIn insulin-treated type 2 diabetes, high-dose pramlintide lowered HbA1c from baseline to week 52 by more than placebo did.

    Outcome
    DecreaseHbA1c at week 52, high dose
    Study

    n: not reported in source

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

    Measurements

    HbA1c change from baseline
    0.6%
    150 microg TID pramlintide, week 52

    Source sentences

    Summary
    In the 150-microg dose group, there was a mean reduction in HbA1c of 0.6% from baseline to week 52 (p = 0.0068 compared to placebo).
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In insulin-treated type 2 diabetes, pramlintide improved HbA1c without increased insulin use.

    In plain wordsIn insulin-treated type 2 diabetes, pramlintide improved blood sugar without increased insulin use.

    Outcome
    No significant changeInsulin use
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    30, 75, or 150 microg TID · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The greater reduction in HbA1c with pramlintide was achieved without increases in insulin use or severe hypoglycemia, and was accompanied by a significant (p < 0.05) reduction in body weight in all dose groups compared to placebo.
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  5. 05HumanRandomized controlled trialSafety outcome

    In insulin-treated type 2 diabetes, pramlintide improved HbA1c without increased severe hypoglycemia.

    In plain wordsIn insulin-treated type 2 diabetes, pramlintide improved blood sugar without increased 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
    30, 75, or 150 microg TID · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The greater reduction in HbA1c with pramlintide was achieved without increases in insulin use or severe hypoglycemia, and was accompanied by a significant (p < 0.05) reduction in body weight in all dose groups compared to placebo.
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  6. 06HumanRandomized controlled trialEfficacy outcome

    In insulin-treated type 2 diabetes, pramlintide at 30, 75 and 150 microg TID significantly reduced body weight versus placebo (p < 0.05).

    In plain wordsIn insulin-treated type 2 diabetes, pramlintide at all three doses reduced weight more than placebo.

    Outcome
    DecreaseBody weight, all dose groups
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    30, 75, or 150 microg TID · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The greater reduction in HbA1c with pramlintide was achieved without increases in insulin use or severe hypoglycemia, and was accompanied by a significant (p < 0.05) reduction in body weight in all dose groups compared to placebo.
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  7. 07HumanRandomized controlled trialEfficacy outcome

    In insulin-treated type 2 diabetes, 48% with pramlintide achieved concurrent HbA1c and weight reductions versus 16% with placebo.

    In plain wordsIn insulin-treated type 2 diabetes, more pramlintide recipients than placebo recipients achieved both lower HbA1c and lower weight.

    Outcome
    IncreaseConcurrent HbA1c and weight reduction
    Study

    n: not reported in source

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

    Measurements

    Proportion with concomitant HbA1c and body weight reduction
    48%
    150 microg pramlintide group, week 52
    Proportion with concomitant HbA1c and body weight reduction
    16%
    placebo group, week 52

    Source sentences

    Summary
    Three times the proportion of subjects in the 150-microg pramlintide group compared to the placebo group achieved a concomitant reduction in both HbA1c and body weight from baseline to week 52 (48% versus 16%).
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…
  8. 08HumanRandomized controlled trialSafety outcome

    In insulin-treated type 2 diabetes, mild-to-moderate nausea was the most common pramlintide adverse event and dissipated early.

    In plain wordsIn insulin-treated type 2 diabetes, mild-to-moderate nausea was the most common pramlintide adverse event and decreased early.

    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    30, 75, or 150 microg TID · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common adverse event reported with pramlintide treatment was nausea, which was mild to moderate and dissipated early in treatment.
    1 context sentence
    Summary · context
    This 52-week, randomized, placebo-controlled, multicenter, double-blind, dose-ranging study in 538 insulin-treated subjects with type 2 diabetes compared the efficacy and safety of 30-, 75-, or 150-microg doses of pramlintide, a synthetic analogue of the beta-cell hormone amylin, to placebo when inj…

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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