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Study · Non-randomized trial · n = 11 · 2009

9 results

Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot study.

Huffman DM, McLean GW, Seagrove MA

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists1 Nov 2009Cited by 18 (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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In patients with type 1 diabetes, hemoglobin A1c decreased during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, hemoglobin A1c decreased from baseline during continuous pramlintide infusion.

    Outcome
    DecreaseHemoglobin A1c
    Study

    n = 11

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Measurements

    A1c
    7.85%
    week 16
    A1c change
    −0.35%
    week 16

    Source sentences

    Summary
    After 16 weeks of pramlintide therapy, mean +/- SD hemoglobin A1c decreased to 7.85% +/- 0.74% (-0.35%).
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  2. 02HumanNon-randomized trialEfficacy outcome

    In patients with type 1 diabetes, fasting glucose decreased during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, fasting glucose decreased from baseline during continuous pramlintide infusion.

    Outcome
    DecreaseFasting glucose
    Study

    n = 11

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Measurements

    Fasting glucose
    198.2 mg/dL
    baseline
    Fasting glucose
    135.8 mg/dL
    after therapy

    Source sentences

    Summary
    The fasting glucose level declined from 198.2 +/- 66.9 mg/dL to 135.8 +/- 63.9 mg/dL.
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  3. 03HumanNon-randomized trialEfficacy outcome

    In patients with type 1 diabetes, weight decreased during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, weight decreased from baseline during continuous pramlintide infusion.

    Outcome
    DecreaseWeight
    Study

    n = 11

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 12 weeksAs given in this study (human).

    Measurements

    Weight
    91.8 kg
    week 12
    Weight change
    −0.5 kg
    week 12

    Source sentences

    Summary
    The mean weight decreased to 91.8 +/- 20.1 kg (-0.5 kg) at week 12.
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  4. 04HumanNon-randomized trialEfficacy outcome

    In patients with type 1 diabetes, daily bolus insulin requirement decreased during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, daily mealtime insulin needs decreased from baseline during continuous pramlintide infusion.

    Outcome
    DecreaseBolus insulin requirement
    Study

    n = 11

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Measurements

    Bolus insulin decrease
    20%
    daily requirement

    Source sentences

    Summary
    The daily bolus insulin requirement decreased 20%; daily basal insulin was unchanged (27.7 +/- 11.7 U).
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  5. 05HumanNon-randomized trialEfficacy outcome

    In patients with type 1 diabetes, daily basal insulin was unchanged during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, daily basal insulin did not change from baseline during continuous pramlintide infusion.

    Outcome
    No significant changeBasal insulin requirement
    Study

    n = 11

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Measurements

    Basal insulin
    27.7 U
    daily

    Source sentences

    Summary
    The daily bolus insulin requirement decreased 20%; daily basal insulin was unchanged (27.7 +/- 11.7 U).
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  6. 06HumanNon-randomized trialSafety outcome

    All patients with type 1 diabetes experienced mild postprandial hypoglycemia during continuous pramlintide infusion.

    In plain wordsAll patients with type 1 diabetes had mild low blood sugar after meals during continuous pramlintide infusion.

    Outcome
    Not applicableMild postprandial hypoglycemia
    Study

    n = 11

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    All patients experienced mild postprandial hypoglycemia, but no severe hypoglycemia was reported.
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  7. 07HumanNon-randomized trialSafety outcome

    In patients with type 1 diabetes, no severe hypoglycemia was reported during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, no severe low blood sugar was reported during continuous pramlintide infusion.

    Outcome
    Not applicableSevere hypoglycemia
    Study

    n = 11

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    All patients experienced mild postprandial hypoglycemia, but no severe hypoglycemia was reported.
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  8. 08HumanNon-randomized trialSafety outcome

    In patients with type 1 diabetes, three participants experienced mild initial nausea during continuous pramlintide infusion.

    In plain wordsIn patients with type 1 diabetes, three participants had mild nausea at the start of continuous pramlintide infusion.

    Outcome
    Not applicableInitial nausea
    Study

    n = 11

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Measurements

    Participants with mild initial nausea
    3 participants
    of 11 study participants

    Source sentences

    Summary
    Three of the 11 study participants experienced mild initial nausea, but all patients successfully titrated bolus doses to 60 microg within 3 weeks.
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent hypoglycemia.
  9. 09HumanNon-randomized trialSafety outcome

    All patients with type 1 diabetes successfully titrated pramlintide boluses to 60 microg within 3 weeks.

    In plain wordsAll patients with type 1 diabetes reached pramlintide bolus doses of 60 microg within 3 weeks.

    Outcome
    Not applicableSuccessful bolus titration
    Study

    n = 11

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    9 microg/h basal infusion; premeal bolus titrated from 15 to 60 microg · subcutaneous infusion · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Three of the 11 study participants experienced mild initial nausea, but all patients successfully titrated bolus doses to 60 microg within 3 weeks.
    4 context sentences
    Summary · context
    A 16-week, open-label, single-arm pilot study enrolled 11 patients (mean +/- SD values: age, 39.9 +/- 4.0 years; hemoglobin A1c, 8.20% +/- 0.60%; weight, 92.3 +/- 18.4 kg; body mass index, 29.7 +/- 5.1 kg/m2) with longterm type 1 diabetes mellitus (20.7 +/- 1.3 years; duration of pump therapy, 9.5 +/- 6.0 years).
    Summary · context
    Pramlintide basal infusion was begun with continuous subcutaneous infusion at 9 microg/h.
    Summary · context
    After 3 days, premeal bolus doses of pramlintide were initiated at 15 microg and titrated to 60 microg per meal.
    Summary · context
    Basal and bolus insulin doses were reduced 10% on initiation of CSPI and adjusted thereafter as needed to prevent 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 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT00502138

A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

University Diabetes & Endocrine Consultantsn = 12Jul 2007 to Jan 2008

IDDM

Trial pageClinicalTrials.govUpdated 16 Jan 2013

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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