Effect of 14 days' subcutaneous administration of the human amylin analogue, pramlintide (AC137), on an intravenous insulin challenge and response to a standard liquid meal in patients with IDDM.

Kolterman OG, Schwartz S, Corder C, Levy B, Klaff L, Peterson J, Gottlieb A

Diabetologia1 Apr 1996Cited by 51 (Europe PMC)

PMID8778001DOI10.1007/bf00400683PepBankPUB-08778001

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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

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialSafety outcome
In patients with IDDM, adverse events did not differ meaningfully between pramlintide 30 micrograms and placebo.
In plain wordsIn patients with IDDM, side effects did not differ meaningfully between pramlintide 30 micrograms and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeAdverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
30 micrograms before meals · subcutaneous · 14 daysAs given in this study (human).
Source sentences
Summary
There was no meaningful difference between adverse events reported by the 30-micrograms pramlintide and the placebo groups, but ten subjects withdrew due to nausea, eight of these in the 300-micrograms dose group.
1 context sentence(design, population, supporting numbers)
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
Report a problemFND-0877800101
02HumanRandomized controlled trialSafety outcome
In patients with IDDM, ten subjects withdrew due to nausea, eight of them in the 300-microgram pramlintide group.
In plain wordsIn patients with IDDM, ten patients stopped treatment because of nausea, eight of them at the highest pramlintide dose.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableWithdrawal due to nausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
300 micrograms before meals · subcutaneous · 14 daysAs given in this study (human).
Measurements
Withdrawals due to nausea
10 subjects
all groups
Withdrawals due to nausea
8 subjects
300-micrograms group
Source sentences
Summary
There was no meaningful difference between adverse events reported by the 30-micrograms pramlintide and the placebo groups, but ten subjects withdrew due to nausea, eight of these in the 300-micrograms dose group.
1 context sentence(design, population, supporting numbers)
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
Report a problemFND-0877800102
03HumanRandomized controlled trialPharmacokinetics
In patients with IDDM, peak pramlintide concentrations were reported on the first and final treatment days.
In plain wordsIn patients with IDDM, peak pramlintide levels were measured on the first and final treatment days.
Peptide
Pramlintide (Symlin)
Outcome
Not applicablePeak plasma pramlintide
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
30 micrograms before meals · subcutaneous · 14 daysAs given in this study (human).
Measurements
Peak pramlintide
21 pmol/l
Day 1
Peak pramlintide
29 pmol/l
Day 14
Source sentences
Summary
Peak plasma pramlintide concentrations for the 30-micrograms group were 21 +/- 3 and 29 +/- 5 pmol/l on Days 1 and 14, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
Report a problemFND-0877800103
04HumanRandomized controlled trialEfficacy outcome
In patients with IDDM, postprandial incremental glucose AUC fell significantly from Day 1 to Day 14 on pramlintide 30 micrograms.
In plain wordsIn patients with IDDM, glucose after a meal was lower on Day 14 than Day 1 with pramlintide 30 micrograms; no placebo comparison was reported.
Peptide
Pramlintide (Symlin)
Outcome
DecreasePostprandial glucose AUC
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 micrograms before meals · subcutaneous · 14 daysAs given in this study (human).
Measurements
Incremental 3-h glucose AUC
322 mmol/l.min
Day 1, 30 micrograms pramlintide
Incremental 3-h glucose AUC
−38 mmol/l.min
Day 14, 30 micrograms pramlintide
Source sentences
Summary
Pramlintide therapy reduced postprandial hyperglycaemia as reflected by the 3-h incremental AUCglucose (AUCglucose above or below fasting glucose concentration) Day 1 vs Day 14: 30 micrograms, 322 +/- 92 vs -38 +/- 161 mmol/l.min, p = 0.010;
1 context sentence(design, population, supporting numbers)
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
Report a problemFND-0877800110
05HumanRandomized controlled trialEfficacy outcome
In patients with IDDM, postprandial incremental glucose AUC fell significantly from Day 1 to Day 14 on pramlintide 100 micrograms.
In plain wordsIn patients with IDDM, glucose after a meal was lower on Day 14 than Day 1 with pramlintide 100 micrograms; no placebo comparison was reported.
Peptide
Pramlintide (Symlin)
Outcome
DecreasePostprandial glucose AUC
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
100 micrograms before meals · subcutaneous · 14 daysAs given in this study (human).
Measurements
Incremental 3-h glucose AUC
317 mmol/l.min
Day 1, 100 micrograms pramlintide
Incremental 3-h glucose AUC
−39 mmol/l.min
Day 14, 100 micrograms pramlintide
Source sentences
Summary
100 micrograms, 317 +/- 92 vs -39 +/- 76 mmol/l.min, p = 0.001;
1 context sentence(design, population, supporting numbers)
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
Report a problemFND-0877800111
06HumanRandomized controlled trialEfficacy outcome
In patients with IDDM, the fall in postprandial incremental glucose AUC from Day 1 to Day 14 on pramlintide 300 micrograms did not reach significance (p = 0.077).
In plain wordsIn patients with IDDM, glucose after meals fell from Day 1 to Day 14 with pramlintide 300 micrograms. The change was not statistically significant.
Peptide
Pramlintide (Symlin)
Outcome
No significant changePostprandial glucose AUC
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
300 micrograms before meals · subcutaneous · 14 daysAs given in this study (human).
Measurements
Incremental 3-h glucose AUC
268 mmol/l.min
Day 1, 300 micrograms pramlintide
Incremental 3-h glucose AUC
−245 mmol/l.min
Day 14, 300 micrograms pramlintide
Source sentences
Summary
and 300 micrograms, 268 +/- 96 vs -245 +/- 189 mmol/l.min, p = 0.077.
1 context sentence(design, population, supporting numbers)
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
Report a problemFND-0877800112

Studies that did not test the peptide alone5

In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Pramlintide (Symlin).

07HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In patients with IDDM, glucose during the insulin infusion test was unchanged before and after pramlintide therapy, as in every group.
In plain wordsIn patients with IDDM, insulin-test glucose was unchanged after treatment in all groups, including pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeGlucose during insulin infusion
Study
n = 84
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The plasma glucose, free insulin, glucagon, epinephrine and norepinephrine concentrations during the insulin infusion test before and after therapy were identical in each of the group.
2 context sentences(design, population, supporting numbers)
Summary · context
We have investigated the effects of amylin replacement therapy employing the human amylin analogue, pramlintide (25, 28, 29-pro-human amylin, previously referred to as AC137), upon the responses to a standardized insulin infusion (40 mU. kg-1. h-1) for 100 min and a liquid Sustacal meal (360 kcal) i…
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-0877800105
08HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In patients with IDDM, free insulin during the insulin infusion test was unchanged before and after treatment in all groups.
In plain wordsIn patients with IDDM, insulin-test free insulin was unchanged after treatment in all groups, including pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeFree insulin during insulin infusion
Study
n = 84
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The plasma glucose, free insulin, glucagon, epinephrine and norepinephrine concentrations during the insulin infusion test before and after therapy were identical in each of the group.
2 context sentences(design, population, supporting numbers)
Summary · context
We have investigated the effects of amylin replacement therapy employing the human amylin analogue, pramlintide (25, 28, 29-pro-human amylin, previously referred to as AC137), upon the responses to a standardized insulin infusion (40 mU. kg-1. h-1) for 100 min and a liquid Sustacal meal (360 kcal) i…
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-0877800106
09HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In patients with IDDM, glucagon during the insulin infusion test was unchanged before and after treatment in all groups.
In plain wordsIn patients with IDDM, insulin-test glucagon was unchanged after treatment in all groups, including pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeGlucagon during insulin infusion
Study
n = 84
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The plasma glucose, free insulin, glucagon, epinephrine and norepinephrine concentrations during the insulin infusion test before and after therapy were identical in each of the group.
2 context sentences(design, population, supporting numbers)
Summary · context
We have investigated the effects of amylin replacement therapy employing the human amylin analogue, pramlintide (25, 28, 29-pro-human amylin, previously referred to as AC137), upon the responses to a standardized insulin infusion (40 mU. kg-1. h-1) for 100 min and a liquid Sustacal meal (360 kcal) i…
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-0877800107
10HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In patients with IDDM, epinephrine during the insulin infusion test was unchanged before and after treatment in all groups.
In plain wordsIn patients with IDDM, insulin-test epinephrine was unchanged after treatment in all groups, including pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeEpinephrine during insulin infusion
Study
n = 84
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The plasma glucose, free insulin, glucagon, epinephrine and norepinephrine concentrations during the insulin infusion test before and after therapy were identical in each of the group.
2 context sentences(design, population, supporting numbers)
Summary · context
We have investigated the effects of amylin replacement therapy employing the human amylin analogue, pramlintide (25, 28, 29-pro-human amylin, previously referred to as AC137), upon the responses to a standardized insulin infusion (40 mU. kg-1. h-1) for 100 min and a liquid Sustacal meal (360 kcal) i…
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-0877800108
11HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In patients with IDDM, norepinephrine during the insulin infusion test was unchanged before and after treatment in all groups.
In plain wordsIn patients with IDDM, insulin-test norepinephrine was unchanged after treatment in all groups, including pramlintide and placebo.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeNorepinephrine during insulin infusion
Study
n = 84
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The plasma glucose, free insulin, glucagon, epinephrine and norepinephrine concentrations during the insulin infusion test before and after therapy were identical in each of the group.
2 context sentences(design, population, supporting numbers)
Summary · context
We have investigated the effects of amylin replacement therapy employing the human amylin analogue, pramlintide (25, 28, 29-pro-human amylin, previously referred to as AC137), upon the responses to a standardized insulin infusion (40 mU. kg-1. h-1) for 100 min and a liquid Sustacal meal (360 kcal) i…
Summary · context
Following baseline evaluations, patients were randomly assigned to receive subcutaneous injections of placebo, 30, 100 or 300 micrograms pramlintide 30 min before meals for 14 days.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-0877800109

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.

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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