Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL).

Bethel MA, Patel RA, Thompson VP, Merrill P, Reed SD, Li Y, Ahmadi S, Katona BG, Gustavson SM, Ohman P, Iqbal N, Gagel RF, Hernandez AF, Buse JB, Holman RR

Diabetes care22 Apr 2019Cited by 31 (Europe PMC)

PMID31010875PMCIDPMC6973544DOI10.2337/dc18-2028PepBankPUB-31010875

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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 study3

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

01HumanRandomized controlled trialSafety outcome
In EXSCEL, calcitonin reached the follow-up discontinuation threshold in 15 exenatide participants and 8 placebo participants.
In plain wordsIn EXSCEL, 15 exenatide participants and 8 placebo participants reached the calcitonin threshold during follow-up.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedElevated calcitonin during follow-up
Study
n: not reported in source
Comparator
placebo
Outcome group
Adverse events · Endocrine and hormones
Studied dose
2 mg once weeklyAs given in this study (human).
Measurements
Participants with calcitonin ≥50 ng/L during follow-up
15 participants
exenatide
Participants with calcitonin ≥50 ng/L during follow-up
8 participants
placebo
Source sentences
Summary
At baseline, 52 (30 exenatide and 22 placebo) participants had calcitonin >40 ng/L, and during follow-up an additional 23 participants (15 exenatide and 8 placebo) had calcitonin ≥50 ng/L in the intention-to-treat population.
1 context sentence(design, population, supporting numbers)
Summary · context
EXSCEL participants were randomized 1:1 to once-weekly exenatide 2 mg or placebo.
Report a problemFND-3101087501
02HumanRandomized controlled trialSafety outcome
In EXSCEL, median calcitonin was similar between exenatide and placebo at baseline and did not increase over time.
In plain wordsIn EXSCEL, calcitonin was similar between exenatide and placebo at baseline and did not increase over time.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeMedian calcitonin
Study
n: not reported in source
Comparator
placebo
Outcome group
Adverse events · Endocrine and hormones
Studied dose
2 mg once weeklyAs given in this study (human).
Source sentences
Summary
Median calcitonin concentrations were similar between treatment groups at baseline with no increase over time.
1 context sentence(design, population, supporting numbers)
Summary · context
EXSCEL participants were randomized 1:1 to once-weekly exenatide 2 mg or placebo.
Report a problemFND-3101087502
03HumanRandomized controlled trialSafety outcome
In EXSCEL, confirmed medullary thyroid carcinoma occurred in 2 exenatide participants and 1 placebo participant, all with markedly elevated baseline calcitonin.
In plain wordsIn EXSCEL, thyroid cancer occurred in 2 exenatide participants and 1 placebo participant, all with high calcitonin before treatment.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedMedullary thyroid carcinoma
Study
n: not reported in source
Comparator
placebo
Outcome group
Adverse events · Cancer
Studied dose
2 mg once weeklyAs given in this study (human).
Measurements
Confirmed medullary thyroid carcinoma
2 participants
exenatide
Confirmed medullary thyroid carcinoma
1 participants
placebo
Source sentences
Summary
Confirmed MTC occurred in three participants (2 exenatide and 1 placebo), all of whom had significantly elevated baseline calcitonin values (413, 422, and 655 ng/L).
1 context sentence(design, population, supporting numbers)
Summary · context
EXSCEL participants were randomized 1:1 to once-weekly exenatide 2 mg or placebo.
Report a problemFND-3101087503

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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 3Results postedNCT01144338

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

AstraZenecan = 14,75218 Jun 2010 to 24 Apr 2017

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 8 Aug 2018

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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