Trial · NCT01077323
A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents
NCT01077323, Completed, AstraZeneca; results first posted 2010-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents. Trials, record NCT01077323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01077323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents
- NCT number
- NCT01077323
- Status
- Completed
- Enrollment
- 363,766 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies), Healthy Subjects (Treated With no Diabetes Therapies)
- Interventions
- exenatide, Other antidiabetic therapies, No diabetes therapy
- First posted
- 2010-03-01
- Last updated
- 2015-04-15
- Results first posted
- 2010-10-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Current Use" Period) - Time on Drug Analysis | 43 months | Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is "current use" period, described as "time during current day's supply plus 31 days." |
| Primary | Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among "Recent Use" Period) - Time on Drug Analysis | 43 months | Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is the "recent use" period, described as "time following current use plus an additional 31 days excluding subsequent current use." |
| Primary | Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Past Use" Period) - Time on Drug Analysis | 43 months | Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is "past use" period, described as "time following recent use excluding subsequent current or recent use." |
| Secondary | 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 | 43 months | Crude intent-to-treat incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis | 43 months | Time on Drug Analysis | Cases per 100,000 person-years | NUMBER |
| SECONDARY | 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 | 43 months | Intent to Treat Analysis | Cases per 100,000 person-years | NUMBER |
| PRIMARY | Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis | 43 months | Time on Drug Analysis | Cases per 100,000 person-years | NUMBER |
| PRIMARY | Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Past Use Period) - Time on Drug Analysis | 43 months | Time on Drug Analysis | Cases per 100,000 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis | Exenatide Initiators | 219.7 | 95% Confidence Interval 155.5 to 301.6 | Cases per 100,000 person-years | |
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis | Other Antidiabetic Drug (OADs) Initiators | 226.7 | 95% Confidence Interval 205.4 to 249.6 | Cases per 100,000 person-years | |
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis | Non-Diabetes Cohort | 56.2 | 95% Confidence Interval 43.7 to 71.1 | Cases per 100,000 person-years | |
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 | Exenatide Initiators | 272.7 | 95% Confidence Interval 215.6 to 340.4 | Cases per 100,000 person-years | |
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 | Other Antidiabetic Drug (OADs) Initiators | 227.6 | 95% Confidence Interval 209.4 to 246.9 | Cases per 100,000 person-years | |
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 | Non-Diabetes Cohort | 56.2 | 95% Confidence Interval 43.7 to 71.1 | Cases per 100,000 person-years | |
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis | Exenatide Initiators | 321.4 | 95% Confidence Interval 117.9 to 699.5 | Cases per 100,000 person-years | |
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis | Other Antidiabetic Drug (OADs) Initiators | 325.5 | 95% Confidence Interval 243.8 to 425.7 | Cases per 100,000 person-years | |
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis | Non-Diabetes Cohort | 56.2 | 95% Confidence Interval 43.7 to 71.1 | Cases per 100,000 person-years | |
| Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Past Use Period) - Time on Drug Analysis | Exenatide Initiators | 354.5 | 95% Confidence Interval 245.5 to 495.4 | Cases per 100,000 person-years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exenatide Initiators | 37,097 | |
| Overall Study | STARTED | Other Antidiabetic Drug (OADs) Initiators | 620,799 | |
| Overall Study | STARTED | Non-Diabetes Cohort | 12,015,600 | |
| Overall Study | COMPLETED | Exenatide Initiators | 25,719 | |
| Overall Study | COMPLETED | Other Antidiabetic Drug (OADs) Initiators | 234,536 | |
| Overall Study | COMPLETED | Non-Diabetes Cohort | 103,511 | |
| Overall Study | NOT COMPLETED | Exenatide Initiators | 11,378 | |
| Overall Study | NOT COMPLETED | Other Antidiabetic Drug (OADs) Initiators | 386,263 | |
| Overall Study | NOT COMPLETED | Non-Diabetes Cohort | 11,912,089 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exenatide Initiators | ||
| Total, all-cause mortality | Other Antidiabetic Drug (OADs) Initiators | ||
| Total, all-cause mortality | Non-Diabetes Cohort | ||
| Total, other adverse events | Exenatide Initiators | 0 | 0 |
| Total, other adverse events | Other Antidiabetic Drug (OADs) Initiators | 0 | 0 |
| Total, other adverse events | Non-Diabetes Cohort | 0 | 0 |
| Total, serious adverse events | Exenatide Initiators | 0 | 0 |
| Total, serious adverse events | Other Antidiabetic Drug (OADs) Initiators | 0 | 0 |
| Total, serious adverse events | Non-Diabetes Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01077323
GET https://conductscience.org/api/trials/v1/NCT01077323/registered