Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial.

Ratner RE, Dickey R, Fineman M, Maggs DG, Shen L, Strobel SA, Weyer C, Kolterman OG

Diabetic medicine : a journal of the British Diabetic Association1 Nov 2004Cited by 214 (Europe PMC)

PMID15498087DOI10.1111/j.1464-5491.2004.01319.xPepBankPUB-15498087

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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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide TID reduced HbA1c by 0.29% versus 0.04% with placebo.
In plain wordsIn type 1 diabetes, pramlintide TID reduced HbA1c more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHbA1c at week 52, TID
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
60 microg TID · injection · 52 weeksAs given in this study (human).
Measurements
HbA1c reduction from baseline
0.29%
pramlintide 60 microg TID, week 52
HbA1c reduction from baseline
0.04%
placebo, week 52
Source sentences
Summary
Addition of pramlintide [60 microg three times daily (TID) or four times daily (QID)] to insulin led to significant reductions in HbA(1c) from baseline to Week 52 of 0.29% (P < 0.011) and 0.34% (P < 0.001), respectively, compared with a 0.04% reduction in placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808701
02HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide QID reduced HbA1c by 0.34% versus 0.04% with placebo.
In plain wordsIn type 1 diabetes, pramlintide QID reduced HbA1c more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHbA1c at week 52, QID
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
60 microg QID · injection · 52 weeksAs given in this study (human).
Measurements
HbA1c reduction from baseline
0.34%
pramlintide 60 microg QID, week 52
HbA1c reduction from baseline
0.04%
placebo, week 52
Source sentences
Summary
Addition of pramlintide [60 microg three times daily (TID) or four times daily (QID)] to insulin led to significant reductions in HbA(1c) from baseline to Week 52 of 0.29% (P < 0.011) and 0.34% (P < 0.001), respectively, compared with a 0.04% reduction in placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808702
03HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, three times as many pramlintide recipients as placebo recipients achieved HbA1c below 7%.
In plain wordsIn type 1 diabetes, more pramlintide recipients than placebo recipients reached the blood sugar target.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseHbA1c below target
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
Three times the proportion of pramlintide- than placebo-treated patients achieved an HbA(1c) of < 7%.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808703
04HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, the HbA1c reduction with pramlintide was achieved without an increase in concomitant insulin use.
In plain wordsIn type 1 diabetes, the HbA1c drop with pramlintide came without an increase in insulin use.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeInsulin use
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
The greater reduction in HbA(1c) with pramlintide was achieved without an increase in concomitant insulin use and was accompanied by a significant reduction in body weight from baseline to Week 52 of 0.4 kg in the 60 microg TID (P < 0.027) or QID (P < 0.040) pramlintide treatment groups, compared wi…
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808704
05HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide TID reduced weight by 0.4 kg versus a 0.8-kg gain with placebo.
In plain wordsIn type 1 diabetes, weight fell with pramlintide TID and increased with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight, TID
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
60 microg TID · injection · 52 weeksAs given in this study (human).
Measurements
Weight reduction from baseline
0.4 kg
pramlintide 60 microg TID, week 52
Weight gain from baseline
0.8 kg
placebo, week 52
Source sentences
Summary
The greater reduction in HbA(1c) with pramlintide was achieved without an increase in concomitant insulin use and was accompanied by a significant reduction in body weight from baseline to Week 52 of 0.4 kg in the 60 microg TID (P < 0.027) or QID (P < 0.040) pramlintide treatment groups, compared wi…
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808705
06HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide QID reduced weight by 0.4 kg versus a 0.8-kg gain with placebo.
In plain wordsIn type 1 diabetes, weight fell with pramlintide QID and increased with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight, QID
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
60 microg QID · injection · 52 weeksAs given in this study (human).
Measurements
Weight reduction from baseline
0.4 kg
pramlintide 60 microg QID, week 52
Weight gain from baseline
0.8 kg
placebo, week 52
Source sentences
Summary
The greater reduction in HbA(1c) with pramlintide was achieved without an increase in concomitant insulin use and was accompanied by a significant reduction in body weight from baseline to Week 52 of 0.4 kg in the 60 microg TID (P < 0.027) or QID (P < 0.040) pramlintide treatment groups, compared wi…
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808706
07HumanRandomized controlled trialSafety outcome
In type 1 diabetes, transient mild-to-moderate nausea was the most common adverse event with pramlintide.
In plain wordsIn type 1 diabetes, temporary mild-to-moderate nausea was the most common adverse event with pramlintide.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · injection · 52 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse event in pramlintide-treated patients was transient, mild-to-moderate nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 +/- 13 years, HbA(1c) 8.9 +/- 1.0%, mean +/- sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Report a problemFND-1549808707

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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