Pramlintide lowered glucose excursions and was well-tolerated in adolescents with type 1 diabetes: results from a randomized, single-blind, placebo-controlled, crossover study.

Chase HP, Lutz K, Pencek R, Zhang B, Porter L

The Journal of pediatrics21 May 2009Cited by 27 (Europe PMC)

PMID19464026DOI10.1016/j.jpeds.2009.03.012PepBankPUB-19464026

Publisher page PubMedAsk about this study

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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialPharmacokinetics
In adolescents with type 1 diabetes, plasma pramlintide concentrations increased dose-proportionately.
In plain wordsIn adolescents with type 1 diabetes, higher pramlintide doses produced proportionately higher blood levels.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseDose proportionality
Study
n = 9
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
15 or 30 microgAs given in this study (human).
Source sentences
Summary
In 9 evaluable subjects, plasma pramlintide concentrations increased dose-proportionately; mean peak plasma concentration (C(max)) (15-microg dose, 93 +/- 9 pg/mL; 30-microg dose, 202 +/- 21 pg/mL) occurred approximately 0.3 h (median time to peak concentration) after administration.
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402601
02HumanRandomized controlled trialPharmacokinetics
In adolescents with type 1 diabetes, pramlintide peak concentration was 93 +/- 9 pg/mL after the 15-microg dose.
In plain wordsIn adolescents with type 1 diabetes, the lower pramlintide dose produced a peak blood concentration of 93 pg/mL.
Peptide
Pramlintide (Symlin)
Outcome
Not applicablePeak plasma concentration at lower dose
Study
n = 9
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
15 microgAs given in this study (human).
Measurements
Cmax
93 pg/mL
15-microg dose
Median Tmax
≈ 0.3 h
after administration
Source sentences
Summary
In 9 evaluable subjects, plasma pramlintide concentrations increased dose-proportionately; mean peak plasma concentration (C(max)) (15-microg dose, 93 +/- 9 pg/mL; 30-microg dose, 202 +/- 21 pg/mL) occurred approximately 0.3 h (median time to peak concentration) after administration.
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402602
03HumanRandomized controlled trialPharmacokinetics
In adolescents with type 1 diabetes, pramlintide peak concentration was 202 +/- 21 pg/mL after the 30-microg dose.
In plain wordsIn adolescents with type 1 diabetes, the higher pramlintide dose produced a peak blood concentration of 202 pg/mL.
Peptide
Pramlintide (Symlin)
Outcome
Not applicablePeak plasma concentration at higher dose
Study
n = 9
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
30 microgAs given in this study (human).
Measurements
Cmax
202 pg/mL
30-microg dose
Median Tmax
≈ 0.3 h
after administration
Source sentences
Summary
In 9 evaluable subjects, plasma pramlintide concentrations increased dose-proportionately; mean peak plasma concentration (C(max)) (15-microg dose, 93 +/- 9 pg/mL; 30-microg dose, 202 +/- 21 pg/mL) occurred approximately 0.3 h (median time to peak concentration) after administration.
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402603
04HumanRandomized controlled trialEfficacy outcome
In adolescents with type 1 diabetes, pramlintide 15 microg reduced glucagon incremental AUC versus placebo.
In plain wordsIn adolescents with type 1 diabetes, pramlintide 15 microg reduced glucagon after meals compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseGlucagon incremental AUC at lower dose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 microgAs given in this study (human).
Measurements
Glucagon incremental AUC
4 pg*h/mL
15-microg dose
Glucagon incremental AUC
35 pg*h/mL
placebo
Source sentences
Summary
Pramlintide reduced incremental area under the concentration curve (AUC(0-3h)) for glucagon and glucose versus placebo (glucagon: 15-microg dose, 4 +/- 7 pg(*)h/mL; 30-microg dose, 5 +/- 7 pg(*)h/mL; placebo, 35 +/- 9 pg(*)h/mL; glucose: 15-microg dose, 129 +/- 43 mg(*)h/dL; 30-microg dose, 132 +/-…
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402604
05HumanRandomized controlled trialEfficacy outcome
In adolescents with type 1 diabetes, pramlintide 30 microg reduced glucagon incremental AUC versus placebo.
In plain wordsIn adolescents with type 1 diabetes, pramlintide 30 microg reduced glucagon after meals compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseGlucagon incremental AUC at higher dose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 microgAs given in this study (human).
Measurements
Glucagon incremental AUC
5 pg*h/mL
30-microg dose
Glucagon incremental AUC
35 pg*h/mL
placebo
Source sentences
Summary
Pramlintide reduced incremental area under the concentration curve (AUC(0-3h)) for glucagon and glucose versus placebo (glucagon: 15-microg dose, 4 +/- 7 pg(*)h/mL; 30-microg dose, 5 +/- 7 pg(*)h/mL; placebo, 35 +/- 9 pg(*)h/mL; glucose: 15-microg dose, 129 +/- 43 mg(*)h/dL; 30-microg dose, 132 +/-…
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402605
06HumanRandomized controlled trialEfficacy outcome
In adolescents with type 1 diabetes, pramlintide 15 microg reduced glucose incremental AUC versus placebo.
In plain wordsIn adolescents with type 1 diabetes, pramlintide 15 microg reduced glucose after meals compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseGlucose incremental AUC at lower dose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 microgAs given in this study (human).
Measurements
Glucose incremental AUC
129 mg*h/dL
15-microg dose
Glucose incremental AUC
217 mg*h/dL
placebo
Source sentences
Summary
Pramlintide reduced incremental area under the concentration curve (AUC(0-3h)) for glucagon and glucose versus placebo (glucagon: 15-microg dose, 4 +/- 7 pg(*)h/mL; 30-microg dose, 5 +/- 7 pg(*)h/mL; placebo, 35 +/- 9 pg(*)h/mL; glucose: 15-microg dose, 129 +/- 43 mg(*)h/dL; 30-microg dose, 132 +/-…
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402606
07HumanRandomized controlled trialEfficacy outcome
In adolescents with type 1 diabetes, pramlintide 30 microg reduced glucose incremental AUC versus placebo.
In plain wordsIn adolescents with type 1 diabetes, pramlintide 30 microg reduced glucose after meals compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseGlucose incremental AUC at higher dose
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 microgAs given in this study (human).
Measurements
Glucose incremental AUC
132 mg*h/dL
30-microg dose
Glucose incremental AUC
217 mg*h/dL
placebo
Source sentences
Summary
Pramlintide reduced incremental area under the concentration curve (AUC(0-3h)) for glucagon and glucose versus placebo (glucagon: 15-microg dose, 4 +/- 7 pg(*)h/mL; 30-microg dose, 5 +/- 7 pg(*)h/mL; placebo, 35 +/- 9 pg(*)h/mL; glucose: 15-microg dose, 129 +/- 43 mg(*)h/dL; 30-microg dose, 132 +/-…
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402607
08HumanRandomized controlled trialMechanism
In adolescents with type 1 diabetes, pramlintide decreased acetaminophen peak concentration versus placebo.
In plain wordsIn adolescents with type 1 diabetes, pramlintide lowered the peak acetaminophen level compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseAcetaminophen peak concentration
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
15 or 30 microgAs given in this study (human).
Source sentences
Summary
Acetaminophen C(max) decreased with pramlintide; median T(max) was delayed by approximately 2.6- to 3.8-fold.
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402608
09HumanRandomized controlled trialMechanism
In adolescents with type 1 diabetes, pramlintide delayed median acetaminophen time to peak approximately 2.6- to 3.8-fold.
In plain wordsIn adolescents with type 1 diabetes, pramlintide delayed the acetaminophen peak compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseAcetaminophen time to peak
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal motility · Gastrointestinal
Studied dose
15 or 30 microgAs given in this study (human).
Measurements
Median Tmax delay
2.6 to 3.8 fold
pramlintide
Source sentences
Summary
Acetaminophen C(max) decreased with pramlintide; median T(max) was delayed by approximately 2.6- to 3.8-fold.
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402609
10HumanRandomized controlled trialSafety outcome
In adolescents with type 1 diabetes, pramlintide was well tolerated with no treatment-related adverse events.
In plain wordsIn adolescents with type 1 diabetes, pramlintide was well tolerated with no treatment-related adverse events.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableTreatment-related adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
15 or 30 microgAs given in this study (human).
Source sentences
Summary
Pramlintide was well tolerated, and no treatment-related adverse events occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
Twelve subjects (9 females, 3 males, age 12 to 17 years; A1C, 8.4%; body mass index, 25 kg/m(2)) were randomized to pramlintide (15 or 30 microg) or placebo administered before a standardized breakfast.
Summary · context
Insulin lispro (50% of usual mealtime dose) was injected separately.
Report a problemFND-1946402610

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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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

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