Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy.

Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG

Postgraduate medicine1 May 2013Cited by 20 (Europe PMC)

PMID23748514DOI10.3810/pgm.2013.05.2635PepBankPUB-23748514

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with T1DM, HbA1c reductions were similar with pramlintide and placebo.
In plain wordsIn patients with T1DM, pramlintide and placebo produced similar HbA1c reductions.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeHbA1c
Study
n = 155
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 29 weeksAs given in this study (human).
Measurements
HbA1c change
−0.4%
pramlintide, RCT
HbA1c change
−0.3%
placebo, RCT
Source sentences
Summary
Mean (± standard deviation) reduction in HbA1c level in the clinical practice trial was -0.3% ± 0.1% (P < 0.0001), and in the RCT was similar between pramlintide- and placebo-treated patients (-0.4% ± 0.1% and -0.3% ± 0.1%, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851404
02HumanRandomized controlled trialEfficacy outcome
In patients with T1DM, pramlintide reduced mealtime insulin doses more than placebo.
In plain wordsIn patients with T1DM, pramlintide reduced mealtime insulin doses more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseMealtime insulin dose
Study
n = 155
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 29 weeksAs given in this study (human).
Measurements
Mealtime insulin dose change
−23.8%
pramlintide, RCT
Mealtime insulin dose change
−3.2%
placebo, RCT
Source sentences
Summary
Glycemic improvements were accomplished, with reductions in mealtime insulin doses (RCT: pramlintide, -23.8% ± 5.2%; placebo, -3.2% ± 4.1%; P < 0.0005; clinical practice trial: -27.5% ± 2.9%; P < 0.0001)
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851405
03HumanRandomized controlled trialEfficacy outcome
In patients with T1DM, pramlintide reduced body weight compared with placebo.
In plain wordsIn patients with T1DM, pramlintide reduced body weight compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight
Study
n = 155
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 29 weeksAs given in this study (human).
Measurements
Body weight change
−2.2 kg
pramlintide, RCT
Body weight change
1.4 kg
placebo, RCT
Source sentences
Summary
and body weight (RCT: pramlintide, -2.2 kg ± 0.5 kg; placebo, +1.4 kg ± 0.3 kg; P < 0.0001; clinical practice trial: -3.2 kg ± 0.4 kg; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851407
04HumanRandomized controlled trialSafety outcome
In patients with T1DM, severe hypoglycemia rates were numerically higher with pramlintide than placebo.
In plain wordsIn patients with T1DM, severe low blood sugar rates were numerically higher with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseSevere hypoglycemia
Study
n = 155
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 29 weeksAs given in this study (human).
Measurements
Severe hypoglycemia rate
0.56 events per patient-year
pramlintide
Severe hypoglycemia rate
0.34 events per patient-year
placebo
Source sentences
Summary
Severe hypoglycemic events occurred at a rate of 0.56 and 0.34 events per patient-year in pramlintide- and placebo-treated patients, respectively, in the RCT, and at a rate of 0.12 events per patient-year in the clinical practice trial.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851410
05HumanObservational studyEfficacy outcome
In the clinical practice study, HbA1c decreased during pramlintide treatment.
In plain wordsIn the clinical practice study, pramlintide treatment was linked to lower HbA1c than baseline.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHbA1c
Study
n = 150
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 6 monthsAs given in this study (human).
Measurements
HbA1c change
−0.3%
clinical practice trial
Source sentences
Summary
Mean (± standard deviation) reduction in HbA1c level in the clinical practice trial was -0.3% ± 0.1% (P < 0.0001), and in the RCT was similar between pramlintide- and placebo-treated patients (-0.4% ± 0.1% and -0.3% ± 0.1%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
Endpoints at 29 weeks (RCT) and 6 months (clinical practice trial) included change in glycated hemoglobin (HbA1c) level, insulin dose, body weight, pre- and postprandial blood glucose level, and tolerability and safety.
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851403
06HumanObservational studyEfficacy outcome
In the clinical practice study, mealtime insulin doses decreased during pramlintide treatment.
In plain wordsIn the clinical practice study, pramlintide treatment was linked to lower mealtime insulin doses than baseline.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseMealtime insulin dose
Study
n = 150
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 6 monthsAs given in this study (human).
Measurements
Mealtime insulin dose change
−27.5%
clinical practice trial
Source sentences
Summary
Glycemic improvements were accomplished, with reductions in mealtime insulin doses (RCT: pramlintide, -23.8% ± 5.2%; placebo, -3.2% ± 4.1%; P < 0.0005; clinical practice trial: -27.5% ± 2.9%; P < 0.0001)
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851406
07HumanObservational studyEfficacy outcome
In the clinical practice study, body weight decreased during pramlintide treatment.
In plain wordsIn the clinical practice study, pramlintide treatment was linked to lower body weight than baseline.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight
Study
n = 150
Outcome group
Body weight · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 6 monthsAs given in this study (human).
Measurements
Body weight change
−3.2 kg
clinical practice trial
Source sentences
Summary
and body weight (RCT: pramlintide, -2.2 kg ± 0.5 kg; placebo, +1.4 kg ± 0.3 kg; P < 0.0001; clinical practice trial: -3.2 kg ± 0.4 kg; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851408
08HumanObservational studySafety outcome
In the clinical practice study, severe hypoglycemia occurred during pramlintide treatment.
In plain wordsIn the clinical practice study, severe low blood sugar occurred during pramlintide treatment.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableSevere hypoglycemia
Study
n = 150
Outcome group
Adverse events · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major meals · 6 monthsAs given in this study (human).
Measurements
Severe hypoglycemia rate
0.12 events per patient-year
clinical practice trial
Source sentences
Summary
Severe hypoglycemic events occurred at a rate of 0.56 and 0.34 events per patient-year in pramlintide- and placebo-treated patients, respectively, in the RCT, and at a rate of 0.12 events per patient-year in the clinical practice trial.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851411
09HumanOther designEfficacy outcome
In patients with T1DM, pramlintide reduced blood glucose excursions across the two studies.
In plain wordsIn patients with T1DM, pramlintide reduced blood glucose excursions.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBlood glucose excursions
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major mealsAs given in this study (human).
Source sentences
Summary
Pramlintide reduced blood glucose excursions and improved the percentage of recorded postprandial blood glucose levels < 180 mg/dL.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851401
10HumanOther designEfficacy outcome
In patients with T1DM, pramlintide improved the percentage of recorded postprandial glucose levels below 180 mg/dL.
In plain wordsIn patients with T1DM, pramlintide increased the proportion of postmeal glucose readings below 180 mg/dL.
Peptide
Pramlintide (Symlin)
Outcome
IncreasePostprandial glucose below target
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 μg titrated to 30 or 60 μg with major mealsAs given in this study (human).
Source sentences
Summary
Pramlintide reduced blood glucose excursions and improved the percentage of recorded postprandial blood glucose levels < 180 mg/dL.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851402
11HumanOther designSafety outcome
In patients with T1DM, short-lived, mainly mild to moderate nausea was the most common adverse event with pramlintide.
In plain wordsIn patients with T1DM, brief nausea was the most common adverse event with pramlintide.
Peptide
Pramlintide (Symlin)
Outcome
Direction not reportedNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
15 μg titrated to 30 or 60 μg with major mealsAs given in this study (human).
Source sentences
Summary
Short-lived nausea, primarily mild to moderate in intensity, was the most common adverse event associated with pramlintide therapy.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a post hoc analysis of 2 studies: a 29-week, multicenter, randomized, double-blind, placebo-controlled trial (referred to as RCT) (pramlintide, n = 82; placebo, n = 73) and an open-ended, multicenter, open-label, single-arm, observational study (referred to as clinical practice trial) (n = 150),
Report a problemFND-2374851409

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 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 page ClinicalTrials.govUpdated 21 May 2015

CompletedPhase 3NCT00042458

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

AstraZenecan = 296Apr 2002 to Mar 2003

Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 23 Sept 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.

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

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