A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes.

Whitehouse F, Kruger DF, Fineman M, Shen L, Ruggles JA, Maggs DG, Weyer C, Kolterman OG

Diabetes care1 Apr 2002Cited by 195 (Europe PMC)

PMID11919132DOI10.2337/diacare.25.4.724PepBankPUB-11919132

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide reduced HbA1c by 0.67% at week 13 versus 0.16% with placebo.
In plain wordsIn type 1 diabetes, pramlintide reduced HbA1c more than placebo at week 13.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHbA1c at week 13
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 microg q.i.d. · injection · 13 weeksAs given in this study (human).
Measurements
HbA1c reduction from baseline at week 13
0.67%
pramlintide
HbA1c reduction from baseline at week 13
0.16%
placebo
Source sentences
Summary
Treatment with pramlintide led to a mean reduction in HbA(1c) of 0.67% from baseline to week 13 that was significantly (P < 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained through week 52 (P = 0.0071).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913201
02HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide sustained a significant placebo-corrected HbA1c reduction through week 52.
In plain wordsIn type 1 diabetes, pramlintide sustained a greater HbA1c reduction than placebo through week 52.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHbA1c through week 52
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 or 60 microg q.i.d. · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
Treatment with pramlintide led to a mean reduction in HbA(1c) of 0.67% from baseline to week 13 that was significantly (P < 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained through week 52 (P = 0.0071).
3 context sentences(design, population, supporting numbers)
Summary · context
Of the 342 patients who completed the 52-week study, 236 individuals ( approximately 70%) elected to participate in a 1-year open-label extension in which all patients received 30 or 60 microg pramlintide q.i.d.
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913202
03HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide treatment was associated with average weight loss rather than weight gain.
In plain wordsIn type 1 diabetes, patients lost weight on average during pramlintide treatment compared with baseline.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
30 or 60 microg q.i.d. · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
The greater HbA(1c) reduction was associated with an average weight loss, rather than weight gain, and was not accompanied by an increased overall event rate of severe hypoglycemia.
4 context sentences(design, population, supporting numbers)
Summary · context
Treatment with pramlintide led to a mean reduction in HbA(1c) of 0.67% from baseline to week 13 that was significantly (P < 0.0001) greater than the placebo reduction (0.16%), and a significant placebo-corrected treatment difference was sustained through week 52 (P = 0.0071).
Summary · context
Of the 342 patients who completed the 52-week study, 236 individuals ( approximately 70%) elected to participate in a 1-year open-label extension in which all patients received 30 or 60 microg pramlintide q.i.d.
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913203
04HumanRandomized controlled trialSafety outcome
In type 1 diabetes, pramlintide did not increase the overall severe hypoglycemia event rate.
In plain wordsIn type 1 diabetes, pramlintide did not increase the overall rate of severe low blood sugar events.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeSevere hypoglycemia rate
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
30 or 60 microg q.i.d. · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
The greater HbA(1c) reduction was associated with an average weight loss, rather than weight gain, and was not accompanied by an increased overall event rate of severe hypoglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913204
05HumanRandomized controlled trialSafety outcome
In type 1 diabetes, mild nausea was a common pramlintide adverse event that occurred early and dissipated over time.
In plain wordsIn type 1 diabetes, mild nausea was common early in pramlintide treatment and decreased over time.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
30 or 60 microg q.i.d. · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse events reported by the pramlintide group were mild nausea and anorexia, which both occurred during the initial weeks of treatment and dissipated over time.
2 context sentences(design, population, supporting numbers)
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913207
06HumanRandomized controlled trialSafety outcome
In type 1 diabetes, anorexia was a common pramlintide adverse event that occurred early and dissipated over time.
In plain wordsIn type 1 diabetes, appetite loss was common early in pramlintide treatment and decreased over time.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableAnorexia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
30 or 60 microg q.i.d. · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse events reported by the pramlintide group were mild nausea and anorexia, which both occurred during the initial weeks of treatment and dissipated over time.
2 context sentences(design, population, supporting numbers)
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913208
07HumanNon-randomized trialEfficacy outcome
In the type 1 diabetes extension, HbA1c decreased rapidly among patients receiving pramlintide for the first time.
In plain wordsIn the type 1 diabetes extension, HbA1c fell quickly in patients who first received pramlintide.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHbA1c in new extension recipients
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 or 60 microg q.i.d. · injection · 1-year open-label extensionAs given in this study (human).
Source sentences
Summary
In the open-label extension, mean HbA(1c) levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients who continued pramlintide treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
Of the 342 patients who completed the 52-week study, 236 individuals ( approximately 70%) elected to participate in a 1-year open-label extension in which all patients received 30 or 60 microg pramlintide q.i.d.
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913205
08HumanNon-randomized trialEfficacy outcome
In the type 1 diabetes extension, HbA1c remained at reduced levels among patients continuing pramlintide.
In plain wordsIn the type 1 diabetes extension, HbA1c remained at its previously reduced level among patients continuing pramlintide.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeHbA1c in continuing extension recipients
Study
n: not reported in source
Comparator
Previously reduced levels
Outcome group
Glycemic control · Metabolic and weight
Studied dose
30 or 60 microg q.i.d. · injection · 1-year open-label extensionAs given in this study (human).
Source sentences
Summary
In the open-label extension, mean HbA(1c) levels decreased rapidly in patients receiving pramlintide for the first time and remained at reduced levels in patients who continued pramlintide treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
Of the 342 patients who completed the 52-week study, 236 individuals ( approximately 70%) elected to participate in a 1-year open-label extension in which all patients received 30 or 60 microg pramlintide q.i.d.
Summary · context
In a 52-week, double-blind, placebo-controlled, multicenter study, 480 patients with type 1 diabetes were randomized to receive preprandial injections of placebo or 30 microg pramlintide q.i.d., in addition to existing insulin regimens.
Summary · context
At week 20, pramlintide-treated patients were re-randomized to 30 or 60 microg pramlintide q.i.d. if decreases from baseline in HbA(1c) were <1% at week 13.
Report a problemFND-1191913206

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

Terms as the source lists them.

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