A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes.

Fayfman M, Galindo RJ, Rubin DJ, Mize DL, Anzola I, Urrutia MA, Ramos C, Pasquel FJ, Haw JS, Vellanki P, Wang H, Albury BS, Weaver R, Cardona S, Umpierrez GE

Diabetes care24 Jan 2019Cited by 54 (Europe PMC)

PMID30679302PMCIDPMC6905476DOI10.2337/dc18-1760PepBankPUB-30679302

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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 study13

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialSafety outcome
In hospitalized patients, nausea or vomiting occurred in 10% with exenatide versus 2% with basal-bolus insulin, without statistical significance.
In plain wordsIn hospitalized patients, nausea or vomiting was numerically more frequent with exenatide than basal-bolus insulin, without statistical significance.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeNausea or vomiting
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5 μg twice dailyAs given in this study (human).
Measurements
Nausea or vomiting
10%
exenatide alone
Nausea or vomiting
2%
basal-bolus insulin
Source sentences
Summary
More patients in the exenatide and exenatide plus basal groups experienced nausea or vomiting than in the basal-bolus group (10% vs. 11% vs. 2%, P = 0.17), with three patients (6%) discontinued exenatide owing to adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
Report a problemFND-3067930205
02HumanRandomized controlled trialSafety outcome
In hospitalized patients, hypoglycemia did not differ among groups, including exenatide alone and basal-bolus insulin.
In plain wordsIn hospitalized patients, low blood glucose did not differ among groups, including exenatide alone and basal-bolus insulin.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHypoglycemia
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Adverse events · Metabolic and weight
Studied dose
5 μg twice dailyAs given in this study (human).
Measurements
Hypoglycemia <54 mg/dL
0%
exenatide alone
Hypoglycemia <54 mg/dL
4%
basal-bolus insulin
Source sentences
Summary
There were no differences in hypoglycemia P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
Report a problemFND-3067930208
03HumanRandomized controlled trialEfficacy outcome
In hospitalized patients, length of stay did not differ among groups, including exenatide alone and basal-bolus insulin.
In plain wordsIn hospitalized patients, hospital stay did not differ among groups, including exenatide alone and basal-bolus insulin.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeLength of stay
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Intensive care and hospital outcomes · Whole body
Studied dose
5 μg twice dailyAs given in this study (human).
Measurements
Length of stay
4 days
exenatide alone
Length of stay
4 days
basal-bolus insulin
Source sentences
Summary
There were no differences in hypoglycemia P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
Report a problemFND-3067930211

Studies that did not test the peptide alone10

In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).

04HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In hospitalized patients with type 2 diabetes, exenatide plus basal insulin had similar daily glucose to basal-bolus insulin.
In plain wordsIn hospitalized patients, exenatide plus basal insulin produced similar daily glucose to basal-bolus insulin.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeMean daily blood glucose versus basal-bolus
Study
n: not reported in source
Comparator
basal-bolus insulin
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Mean daily blood glucose
154 mg/dL
exenatide plus basal insulin
Mean daily blood glucose
166 mg/dL
basal-bolus insulin
Source sentences
Summary
Mean daily BG was similar between patients treated with exenatide plus basal and a basal-bolus regimen (154 ± 39 vs. 166 ± 40 mg/dL, P = 0.31), and exenatide plus basal resulted in lower daily BG than did exenatide alone (177 ± 41 mg/dL, P = 0.02).
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930201
05HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In hospitalized patients with type 2 diabetes, exenatide plus basal insulin lowered daily glucose versus exenatide alone.
In plain wordsIn hospitalized patients, exenatide plus basal insulin lowered daily glucose compared with exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseMean daily blood glucose versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Mean daily blood glucose
154 mg/dL
exenatide plus basal insulin
Mean daily blood glucose
177 mg/dL
exenatide alone
Source sentences
Summary
Mean daily BG was similar between patients treated with exenatide plus basal and a basal-bolus regimen (154 ± 39 vs. 166 ± 40 mg/dL, P = 0.31), and exenatide plus basal resulted in lower daily BG than did exenatide alone (177 ± 41 mg/dL, P = 0.02).
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930202
06HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In hospitalized patients, exenatide plus basal insulin increased glucose readings in target range versus exenatide alone, 78% versus 62%.
In plain wordsIn hospitalized patients, exenatide plus basal insulin increased glucose readings in range compared with exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseGlucose in target range versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Outcome group
Glycemic control · Metabolic and weight
Measurements
BG readings in target range 70-180 mg/dL
78%
exenatide plus basal insulin
BG readings in target range 70-180 mg/dL
62%
exenatide alone
Source sentences
Summary
Exenatide plus basal resulted in a higher proportion of BG levels in target range between 70 and 180 mg/dL compared with exenatide and basal-bolus (78% vs. 62% vs. 63%, respectively, P = 0.023).
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930203
07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In hospitalized patients, exenatide plus basal insulin increased glucose readings in target range versus basal-bolus insulin, 78% versus 63%.
In plain wordsIn hospitalized patients, exenatide plus basal insulin increased glucose readings in range compared with basal-bolus insulin.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseGlucose in target range versus basal-bolus
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Glycemic control · Metabolic and weight
Measurements
BG readings in target range 70-180 mg/dL
78%
exenatide plus basal insulin
BG readings in target range 70-180 mg/dL
63%
basal-bolus insulin
Source sentences
Summary
Exenatide plus basal resulted in a higher proportion of BG levels in target range between 70 and 180 mg/dL compared with exenatide and basal-bolus (78% vs. 62% vs. 63%, respectively, P = 0.023).
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930204
08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In hospitalized patients, nausea or vomiting occurred in 11% with exenatide plus basal versus 2% with basal-bolus insulin, without significance.
In plain wordsIn hospitalized patients, exenatide plus basal insulin had numerically more nausea or vomiting than basal-bolus insulin, without statistical significance.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeNausea or vomiting with combination
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Nausea or vomiting
11%
exenatide plus basal insulin
Nausea or vomiting
2%
basal-bolus insulin
Source sentences
Summary
More patients in the exenatide and exenatide plus basal groups experienced nausea or vomiting than in the basal-bolus group (10% vs. 11% vs. 2%, P = 0.17), with three patients (6%) discontinued exenatide owing to adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930206
09HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In hospitalized patients with type 2 diabetes, three patients (6%) discontinued exenatide because of adverse events.
In plain wordsIn hospitalized patients, three patients (6%) stopped exenatide because of adverse events.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableAdverse-event discontinuation
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Measurements
Discontinued exenatide owing to adverse events
3 patients
exenatide-treated patients
Discontinued exenatide owing to adverse events
6%
exenatide-treated patients
Source sentences
Summary
More patients in the exenatide and exenatide plus basal groups experienced nausea or vomiting than in the basal-bolus group (10% vs. 11% vs. 2%, P = 0.17), with three patients (6%) discontinued exenatide owing to adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930207
10HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In hospitalized patients, hypoglycemia did not differ among groups, including exenatide plus basal insulin and basal-bolus insulin.
In plain wordsIn hospitalized patients, low blood glucose did not differ among groups, including exenatide plus basal and basal-bolus insulin.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHypoglycemia with combination
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Adverse events · Metabolic and weight
Measurements
Hypoglycemia <54 mg/dL
2%
exenatide plus basal insulin
Hypoglycemia <54 mg/dL
4%
basal-bolus insulin
Source sentences
Summary
There were no differences in hypoglycemia P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930209
11HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In hospitalized patients, hypoglycemia did not differ among groups, including exenatide plus basal insulin and exenatide alone.
In plain wordsIn hospitalized patients, low blood glucose did not differ among groups, including exenatide plus basal insulin and exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHypoglycemia combination versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Outcome group
Adverse events · Metabolic and weight
Measurements
Hypoglycemia <54 mg/dL
2%
exenatide plus basal insulin
Hypoglycemia <54 mg/dL
0%
exenatide alone
Source sentences
Summary
There were no differences in hypoglycemia P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930210
12HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In hospitalized patients, length of stay did not differ among groups, including exenatide plus basal insulin and basal-bolus insulin.
In plain wordsIn hospitalized patients, hospital stay did not differ among groups, including exenatide plus basal and basal-bolus insulin.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeLength of stay with combination
Study
n: not reported in source
Comparator
basal-bolus insulin
Outcome group
Intensive care and hospital outcomes · Whole body
Measurements
Length of stay
5 days
exenatide plus basal insulin
Length of stay
4 days
basal-bolus insulin
Source sentences
Summary
There were no differences in hypoglycemia P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930212
13HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In hospitalized patients, length of stay did not differ among groups, including exenatide plus basal insulin and exenatide alone.
In plain wordsIn hospitalized patients, hospital stay did not differ among groups, including exenatide plus basal insulin and exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeLength of stay combination versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Outcome group
Intensive care and hospital outcomes · Whole body
Measurements
Length of stay
5 days
exenatide plus basal insulin
Length of stay
4 days
exenatide alone
Source sentences
Summary
There were no differences in hypoglycemia P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).
In this study, Exenatide (exendin-4) 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 Exenatide (exendin-4).
Report a problemFND-3067930213

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT02455076

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

Emory Universityn = 150Sept 2015 to Mar 2018

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 20 Jun 2019

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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