GLP-1 Peptide Atlas, by Delfa

CompletedResults posted

A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents

A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Byetta (Exenatide) and Other Antidiabetic Agents

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

363,766

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Pancreatitis

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01077323

Org study IDBCA406

Timeline

Milestones

Study first posted2010-03-01estimated

Results first posted2010-10-06estimated

Last update posted2015-04-15estimated

Study start2004-09 (month precision)

Primary completion2008-03actual (month precision)

Study completion2008-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

This retrospective study utilized medical claims data from a large US health plan affiliated with i3 Drug Safety. The individuals covered by this health plan are geographically diverse across the United States. The health plan provides fully insured coverage for physician, hospital and prescription drug services. The providers of these services submit their claims for payment directly to the health plan. i3 Drug Safety uses de-identified data derived from these claims daily for a wide range of safety, utilization, and economic analyses.

Inclusion criteria

•Exenatide Initiators: The date of the first dispensing of exenatide under which a potential cohort member might qualify will be 1 June 2005, and the latest date will be 31 December 2007. We will note the first initiation of exenatide, and also note subsequent initiation of other antidiabetic drugs. Eligible exenatide initiators will be included in the exenatide initiator cohort on the first eligible dispensing following at least 9 months of continuous health plan enrollment.

•Other Antidiabetic Drug Initiators: The date of the first dispensing of an antidiabetic drug other than exenatide under which a potential cohort member might qualify will be 1 June 2005, and the latest date will be 31 December 2007. We will note the earliest date of other antidiabetic drug dispensings within their cohort membership, and also note subsequent initiation of other antidiabetic drugs. We will choose a subset of this comparator cohort randomly selected to be approximately 9 times larger than the exenatide initiators and will oversample patients receiving certain drugs to the extent necessary to ensure inclusion of at least as many persons initiating these drugs as initiating exenatide. Specifically, oversampling will be performed as needed on initiators of metformin, TZDs, SUs, sitagliptin and insulin glargine to allow for further sub-analysis.

•Exenatide and Other Antidiabetic Drug Initiators: For all patients in these two study cohorts, the date of cohort entry (the date ranged between January 1, 2005 and December 31, 2007) marked the beginning of observation for study outcomes (follow-up). The end of observation for a given patient happened on the earliest of occurrence of likely acute pancreatitis, end of the study period (March 31, 2008), or disenrollment from the health plan.

•Non-Diabetes Cohort: A third cohort will consist of randomly-selected Ingenix Research Data Mart members who have no claim associated with a diabetes diagnosis or antidiabetic drug dispensing in the baseline continuous enrollment period. This cohort will enter as of the later of 1 June 2005 or completion of 9 months continuous baseline enrollment and will provide follow-up through end of enrollment or 31 March 2008, or the receipt of an antidiabetic drug dispensing or diabetes diagnosis, at which point they may enter one of the other exposure cohorts.

Exclusion criteria

•The 3 cohorts (exenatide initiators, other antidiabetic initiators, and those without diabetes) will be subject to minimal exclusions in order to observe acute pancreatitis across a wide spectrum of patient characteristics. We will apply a baseline enrollment requirement of 9 months prior to cohort entry so that the first day of follow-up (on which acute pancreatitis could occur) will be characterized with the same level of detail (based on 9 months of preceding health insurance claims) as any other day during the study.

•Consistent with the principle of minimal exclusions, we will only exclude from the cohorts people who have baseline claims associated with pancreatitis (in the 9-month period preceding cohort entry) as these people either had pre-existing pancreatitis or had a pre-existing suspicion of pancreatitis. We will not exclude persons with a type I diabetes diagnosis as we intend to observe the spectrum of clinical practice with respect to antidiabetic drug initiation.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Current Use" Period) - Time on Drug Analysis

Time frame:43 months

Pancreatitis

event count, event

Posted result

Group	Value (number), Cases per 100,000 person-years	95% CI
Exenatide Initiators	219.7	155.5 – 301.6
Other Antidiabetic Drug (OADs) Initiators	226.7	205.4 – 249.6
Non-Diabetes Cohort	56.2	43.7 – 71.1

Adjusted Rate Ratio (ARR)0.8795% CI0.59 – 1.28

Primary/protocol endpoint

Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among "Recent Use" Period) - Time on Drug Analysis

Time frame:43 months

Pancreatitis

event count, event

Posted result

Group	Value (number), Cases per 100,000 person-years	95% CI
Exenatide Initiators	321.4	117.9 – 699.5
Other Antidiabetic Drug (OADs) Initiators	325.5	243.8 – 425.7
Non-Diabetes Cohort	56.2	43.7 – 71.1

Adjusted Rate Ratio (ARR)0.8795% CI0.36 – 2.09

Primary/protocol endpoint

Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Past Use" Period) - Time on Drug Analysis

Time frame:43 months

Pancreatitis

event count, event

Posted result

Group	Value (number), Cases per 100,000 person-years	95% CI
Exenatide Initiators	354.5	245.5 – 495.4
Other Antidiabetic Drug (OADs) Initiators	218.1	183.0 – 258.0
Non-Diabetes Cohort	56.2	43.7 – 71.1

Adjusted Rate Ratio (ARR)1.3995% CI0.86 – 2.25

Secondary/protocol endpoint

Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis Among Initiators of Exenatide, Diabetics Initiating Other Antidiabetic Drugs, and the Non-diabetes Cohort - Intent to Treat Analysis

Time frame:43 months

Pancreatitis

event count, event

Posted result

Group	Value (number), Cases per 100,000 person-years	95% CI
Exenatide Initiators	272.7	215.6 – 340.4
Other Antidiabetic Drug (OADs) Initiators	227.6	209.4 – 246.9
Non-Diabetes Cohort	56.2	43.7 – 71.1

Adjusted Rate Ratio (ARR)1.195% CI0.8 – 1.5

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.