Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing dose-limiting side effects in subjects with type 2 diabetes.

Fineman MS, Shen LZ, Taylor K, Kim DD, Baron AD

Diabetes/metabolism research and reviews1 Sept 2004Cited by 166 (Europe PMC)

PMID15343588DOI10.1002/dmrr.499PepBankPUB-15343588

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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, dose escalation reduced nausea and vomiting at the highest exenatide dose versus initial exposure.
In plain wordsIn patients with type 2 diabetes, gradual exenatide escalation reduced nausea and vomiting versus initial exposure to the highest dose.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNausea and vomiting incidence
Study
n = 99
Comparator
exenatide-naive arm
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.24 micro g/kg TID highest dose, after 35 days of escalation from 0.02 micro g/kg TID in the exenatide-primed arm · subcutaneous · 35 days escalation or placebo, then 3 days at highest doseAs given in this study (human).
Measurements
Nausea and vomiting
27%
exenatide-primed
Nausea and vomiting
56%
exenatide-naive
Source sentences
Summary
The exenatide-primed arm had a lower proportion of subjects experiencing nausea and vomiting in response to exposure to the highest dose of exenatide (27 vs 56% in the exenatide-naive arm; p = 0.0018).
2 context sentences(design, population, supporting numbers)
Summary · context
In this two-arm, triple-blind, multicenter study, 123 subjects with type 2 diabetes were enrolled and randomized; 99 (80.5%) of them completed the study.
Summary · context
At the end of this 35-day regimen, subjects in both arms received the same highest dose of exenatide (0.24 micro g/kg TID) for 3 days.
Report a problemFND-1534358801
02HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, cumulative incidence estimates were lower with exenatide priming than without priming.
In plain wordsIn patients with type 2 diabetes, cumulative nausea and vomiting incidence was lower with exenatide priming than without priming.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseCumulative nausea and vomiting incidence
Study
n = 99
Comparator
exenatide-naive arm
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.24 micro g/kg TID highest dose, after 35 days of escalation from 0.02 micro g/kg TID in the exenatide-primed arm · subcutaneous · 35 days escalation or placebo, then 3 days at highest doseAs given in this study (human).
Measurements
Kaplan-Meier cumulative incidence of nausea and vomiting
0.28 proportion
exenatide-primed arm
Kaplan-Meier cumulative incidence of nausea and vomiting
0.68 proportion
exenatide-naive arm
Source sentences
Summary
Kaplan-Meier estimates of cumulative incidence were 0.28 in the exenatide-primed arm, compared with 0.68 in the exenatide-naive arm (p </= 0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
The exenatide-primed arm had a lower proportion of subjects experiencing nausea and vomiting in response to exposure to the highest dose of exenatide (27 vs 56% in the exenatide-naive arm; p = 0.0018).
Summary · context
In this two-arm, triple-blind, multicenter study, 123 subjects with type 2 diabetes were enrolled and randomized; 99 (80.5%) of them completed the study.
Summary · context
At the end of this 35-day regimen, subjects in both arms received the same highest dose of exenatide (0.24 micro g/kg TID) for 3 days.
Report a problemFND-1534358802
03HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, severe nausea occurred in 29% with exenatide priming versus 48% without priming.
In plain wordsIn patients with type 2 diabetes, severe nausea was less frequent with exenatide priming than without priming.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSevere nausea
Study
n = 99
Comparator
exenatide-naive arm
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.24 micro g/kg TID highest dose, after 35 days of escalation from 0.02 micro g/kg TID in the exenatide-primed arm · subcutaneous · 35 days escalation or placebo, then 3 days at highest doseAs given in this study (human).
Measurements
Severe nausea
29%
exenatide-primed arm
Severe nausea
48%
exenatide-naive arm
Source sentences
Summary
As predicted by the study design, fewer subjects in the exenatide-primed arm reported severe nausea (29%) and vomiting (10%) than those in the exenatide-naive arm (48 and 31%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In this two-arm, triple-blind, multicenter study, 123 subjects with type 2 diabetes were enrolled and randomized; 99 (80.5%) of them completed the study.
Summary · context
At the end of this 35-day regimen, subjects in both arms received the same highest dose of exenatide (0.24 micro g/kg TID) for 3 days.
Report a problemFND-1534358803
04HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, vomiting occurred in 10% with exenatide priming versus 31% without priming.
In plain wordsIn patients with type 2 diabetes, vomiting was less frequent with exenatide priming than without priming.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseVomiting
Study
n = 99
Comparator
exenatide-naive arm
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.24 micro g/kg TID highest dose, after 35 days of escalation from 0.02 micro g/kg TID in the exenatide-primed arm · subcutaneous · 35 days escalation or placebo, then 3 days at highest doseAs given in this study (human).
Measurements
Vomiting
10%
exenatide-primed arm
Vomiting
31%
exenatide-naive arm
Source sentences
Summary
As predicted by the study design, fewer subjects in the exenatide-primed arm reported severe nausea (29%) and vomiting (10%) than those in the exenatide-naive arm (48 and 31%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
In this two-arm, triple-blind, multicenter study, 123 subjects with type 2 diabetes were enrolled and randomized; 99 (80.5%) of them completed the study.
Summary · context
At the end of this 35-day regimen, subjects in both arms received the same highest dose of exenatide (0.24 micro g/kg TID) for 3 days.
Report a problemFND-1534358804
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, fasting glucose declined during exenatide escalation but remained unchanged during placebo.
In plain wordsIn patients with type 2 diabetes, fasting glucose fell during exenatide escalation but stayed unchanged with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting serum glucose
Study
n = 99
Comparator
placebo phase in exenatide-naive arm
Outcome group
Glycemic control · Metabolic and weight
Studied dose
starting at 0.02 micro g/kg TID, increasing by 0.02 micro g/kg per dose every 3 days · subcutaneous · 35 daysAs given in this study (human).
Source sentences
Summary
In the exenatide-primed arm, fasting serum glucose progressively declined over the first 35 days of dosing, but was unchanged in the exenatide-naive arm (placebo phase) during the same interval.
2 context sentences(design, population, supporting numbers)
Summary · context
In this two-arm, triple-blind, multicenter study, 123 subjects with type 2 diabetes were enrolled and randomized; 99 (80.5%) of them completed the study.
Summary · context
Subjects in the exenatide-primed arm received subcutaneous exenatide, starting at 0.02 micro g/kg three times a day (TID) and increasing in 0.02 micro g/kg per dose increments every 3 days for 35 days. Subjects in the exenatide-naive arm received placebo TID for 35 days.
Report a problemFND-1534358805

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

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