A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes.

Edelman S, Garg S, Frias J, Maggs D, Wang Y, Zhang B, Strobel S, Lutz K, Kolterman O

Diabetes care1 Oct 2006Cited by 115 (Europe PMC)

PMID17003291DOI10.2337/dc06-0042PepBankPUB-17003291

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 study6

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

01HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, HbA1c decreased comparably with pramlintide and placebo during intensive insulin therapy.
In plain wordsIn type 1 diabetes, HbA1c fell similarly with pramlintide and placebo during insulin therapy.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeHbA1c
Study
n = 296
Comparator
Placebo with insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 to 60 microg/meal · 29 weeksAs given in this study (human).
Measurements
HbA1c change
−0.5%
pramlintide
HbA1c change
−0.5%
placebo
Source sentences
Summary
Baseline A1C was 8.1% for both groups and at week 29 had decreased comparably (pramlintide -0.5% [95% CI -0.61 to -0.33]; placebo -0.5% [-0.63 to -0.35]).
1 context sentence(design, population, supporting numbers)
Summary · context
This 29-week, double-blind, placebo-controlled study randomized 296 patients to pramlintide or placebo as an adjunct to insulin. During initiation, pramlintide was escalated from 15 to 60 microg/meal (15-microg increments) with recommended reductions (30-50%) in mealtime insulin. Insulin was subsequ…
Report a problemFND-1700329101
02HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide reduced postprandial glucose excursions more than placebo.
In plain wordsIn type 1 diabetes, pramlintide reduced glucose rises after meals more than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreasePostprandial glucose excursions
Study
n = 296
Comparator
Placebo with insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 to 60 microg/meal · 29 weeksAs given in this study (human).
Measurements
Incremental glucose AUC change
−175 mg x h(-1) x dl(-1)
pramlintide
Incremental glucose AUC change
−64 mg x h(-1) x dl(-1)
placebo
Source sentences
Summary
Pramlintide treatment significantly reduced postprandial glucose excursions (incremental area under the curve [AUC](0-3h): pramlintide -175 +/- 40, placebo -64 +/- 38 mg x h(-1) x dl(-1); P < 0.0005) and weight (pramlintide -1.3 +/- 0.30, placebo +1.2 +/- 0.30 kg; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This 29-week, double-blind, placebo-controlled study randomized 296 patients to pramlintide or placebo as an adjunct to insulin. During initiation, pramlintide was escalated from 15 to 60 microg/meal (15-microg increments) with recommended reductions (30-50%) in mealtime insulin. Insulin was subsequ…
Report a problemFND-1700329102
03HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, pramlintide reduced weight compared with placebo.
In plain wordsIn type 1 diabetes, pramlintide reduced weight compared with placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight
Study
n = 296
Comparator
Placebo with insulin
Outcome group
Body weight · Metabolic and weight
Studied dose
15 to 60 microg/meal · 29 weeksAs given in this study (human).
Measurements
Weight change
−1.3 kg
pramlintide
Weight change
1.2 kg
placebo
Source sentences
Summary
Pramlintide treatment significantly reduced postprandial glucose excursions (incremental area under the curve [AUC](0-3h): pramlintide -175 +/- 40, placebo -64 +/- 38 mg x h(-1) x dl(-1); P < 0.0005) and weight (pramlintide -1.3 +/- 0.30, placebo +1.2 +/- 0.30 kg; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This 29-week, double-blind, placebo-controlled study randomized 296 patients to pramlintide or placebo as an adjunct to insulin. During initiation, pramlintide was escalated from 15 to 60 microg/meal (15-microg increments) with recommended reductions (30-50%) in mealtime insulin. Insulin was subsequ…
Report a problemFND-1700329103
04HumanRandomized controlled trialEfficacy outcome
In type 1 diabetes, insulin dose decreased more with pramlintide than placebo at week 29.
In plain wordsIn type 1 diabetes, insulin dose fell more with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseInsulin dose
Study
n = 296
Comparator
Placebo with insulin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 to 60 microg/meal · 29 weeksAs given in this study (human).
Measurements
Insulin dose reduction
28%
pramlintide
Insulin dose reduction
4%
placebo
Source sentences
Summary
At week 29, insulin dose decreased by 28 and 4% in pramlintide- and placebo-treated groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This 29-week, double-blind, placebo-controlled study randomized 296 patients to pramlintide or placebo as an adjunct to insulin. During initiation, pramlintide was escalated from 15 to 60 microg/meal (15-microg increments) with recommended reductions (30-50%) in mealtime insulin. Insulin was subsequ…
Report a problemFND-1700329104
05HumanRandomized controlled trialSafety outcome
In type 1 diabetes, nausea occurred more often with pramlintide than placebo and was predominantly mild to moderate.
In plain wordsIn type 1 diabetes, nausea was more common with pramlintide than placebo, mostly mild to moderate.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseNausea
Study
n = 296
Comparator
Placebo with insulin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
15 to 60 microg/meal · 29 weeksAs given in this study (human).
Measurements
Nausea
63%
pramlintide
Nausea
36%
placebo
Source sentences
Summary
Nausea, reported by 63 and 36% of patients in pramlintide and placebo groups (P < 0.01), respectively, was predominately mild to moderate in intensity.
1 context sentence(design, population, supporting numbers)
Summary · context
This 29-week, double-blind, placebo-controlled study randomized 296 patients to pramlintide or placebo as an adjunct to insulin. During initiation, pramlintide was escalated from 15 to 60 microg/meal (15-microg increments) with recommended reductions (30-50%) in mealtime insulin. Insulin was subsequ…
Report a problemFND-1700329105
06HumanRandomized controlled trialSafety outcome
In type 1 diabetes, severe hypoglycemia rates were higher with pramlintide than placebo.
In plain wordsIn type 1 diabetes, severe low blood sugar was more frequent with pramlintide than placebo.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseSevere hypoglycemia
Study
n = 296
Comparator
Placebo with insulin
Outcome group
Adverse events · Metabolic and weight
Studied dose
15 to 60 microg/meal · 29 weeksAs given in this study (human).
Measurements
Severe hypoglycemia rate
0.57 event rate/patient-year
pramlintide
Severe hypoglycemia rate
0.3 event rate/patient-year
placebo
Source sentences
Summary
Severe hypoglycemia rates were low in both groups (pramlintide 0.57 +/- 0.09, placebo 0.30 +/- 0.06 event rate/patient-year; P < 0.05), with increased rates observed in patients remaining at 30 microg pramlintide.
1 context sentence(design, population, supporting numbers)
Summary · context
This 29-week, double-blind, placebo-controlled study randomized 296 patients to pramlintide or placebo as an adjunct to insulin. During initiation, pramlintide was escalated from 15 to 60 microg/meal (15-microg increments) with recommended reductions (30-50%) in mealtime insulin. Insulin was subsequ…
Report a problemFND-1700329106

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT00460304

The Effect of Pramlintide on Meal Time Insulin Bolus

Diabetes Care Centern = 12Sept 2007 to Nov 2008

Type 1 Diabetes

Trial page ClinicalTrials.govUpdated 3 Apr 2009

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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