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Study · Non-randomized trial · n = 166 · 2007

7 results

Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight.

Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP

Diabetes technology & therapeutics1 Apr 2007Cited by 24 (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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In insulin-treated patients with type 2 diabetes, 29.5% reported nausea during pramlintide treatment, primarily mild to moderate.

    In plain wordsIn patients with type 2 diabetes receiving pramlintide, nausea was primarily mild to moderate.

    Outcome
    Not applicableNausea
    Study

    n = 166

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Measurements

    Nausea
    29.5%
    pramlintide treatment

    Source sentences

    Summary
    Nausea, primarily mild to moderate, was reported by 29.5% of patients (severe nausea in 2.4%).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
  2. 02HumanNon-randomized trialSafety outcome

    In insulin-treated patients with type 2 diabetes, 2.4% reported severe nausea during pramlintide treatment.

    In plain wordsIn patients with type 2 diabetes receiving pramlintide, severe nausea occurred in 2.4%.

    Outcome
    Not applicableSevere nausea
    Study

    n = 166

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Measurements

    Severe nausea
    2.4%
    pramlintide treatment

    Source sentences

    Summary
    Nausea, primarily mild to moderate, was reported by 29.5% of patients (severe nausea in 2.4%).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
  3. 03HumanNon-randomized trialSafety outcome

    In insulin-treated patients with type 2 diabetes, severe hypoglycemia occurred at 0.04 events/patient-year during pramlintide treatment.

    In plain wordsIn patients with type 2 diabetes receiving pramlintide, the reported severe low-glucose event rate was low.

    Outcome
    Not applicableSevere hypoglycemia
    Study

    n = 166

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Measurements

    Severe hypoglycemia rate
    0.04 events/patient-year
    pramlintide treatment

    Source sentences

    Summary
    Rates of severe hypoglycemia were low (0.04 events/patient-year).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
  4. 04HumanNon-randomized trialEfficacy outcome

    In insulin-treated patients with type 2 diabetes, weight fell by 2.8 kg during pramlintide treatment versus baseline.

    In plain wordsIn patients with type 2 diabetes, weight fell during pramlintide treatment compared with baseline.

    Outcome
    DecreaseWeight change
    Study

    n = 125

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Measurements

    Weight change
    −2.8 kg
    6 months

    Source sentences

    Summary
    Pramlintide treatment significantly reduced mean postprandial glucose excursions (P < 0.05) and weight (-2.8 kg; P < 0.05; n = 125).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
  5. 05HumanNon-randomized trialEfficacy outcome

    In insulin-treated patients with type 2 diabetes, mealtime insulin doses fell by 10.3% during pramlintide treatment versus baseline.

    In plain wordsIn patients with type 2 diabetes, insulin doses at meals fell during pramlintide treatment compared with baseline.

    Outcome
    DecreaseMealtime insulin dose
    Study

    n = 104

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Measurements

    Mealtime insulin change
    −10.3%
    6 months

    Source sentences

    Summary
    Glycemic benefits were achieved with lower mealtime insulin doses (-10.3%; P < 0.05; n = 104).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
  6. 06HumanNon-randomized trialEfficacy outcome

    In insulin-treated patients with type 2 diabetes, A1C fell by 0.56% from baseline after pramlintide initiation and insulin adjustment.

    In plain wordsIn patients with type 2 diabetes, A1C fell after pramlintide initiation and insulin adjustment compared with baseline.

    Outcome
    DecreaseA1C change
    Study

    n = 59

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Measurements

    A1C change
    −0.56%
    6 months

    Source sentences

    Summary
    At 6 months, the change in A1C from baseline (8.3%) was -0.56% (P < 0.05; n = 59).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.
  7. 07HumanNon-randomized trialEfficacy outcome

    In insulin-treated patients with type 2 diabetes, pramlintide treatment reduced mean postprandial glucose excursions from baseline.

    In plain wordsIn patients with type 2 diabetes, glucose rises after meals decreased during pramlintide treatment compared with baseline.

    Outcome
    DecreasePostprandial glucose excursions
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    120 microg · 6 monthsAs given in this study (human).

    Source sentences

    Summary
    Pramlintide treatment significantly reduced mean postprandial glucose excursions (P < 0.05) and weight (-2.8 kg; P < 0.05; n = 125).
    2 context sentences
    Summary · context
    In this open-label study, 166 insulin-treated patients with type 2 diabetes added pramlintide therapy (120 microg) during an initiation period in which mealtime insulin was reduced by 30-50%.
    Summary · context
    Endpoints included safety, as well as change in A1C, postprandial glucose, weight, insulin dose, and patient satisfaction following 6 months of pramlintide treatment.

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

CompletedPhase 3NCT00108004

Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

AstraZenecan = 400Apr 2003 to Jun 2005

Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 21 May 2015

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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