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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
i3 Drug Safety
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01077323
First received: February 25, 2010
Last updated: March 25, 2015
Last verified: March 2015
Results First Received: August 12, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Type 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies)
Healthy Subjects (Treated With no Diabetes Therapies)
Interventions: Drug: exenatide
Drug: Other antidiabetic therapies
Other: No diabetes therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Exenatide Initiators Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
Other Antidiabetic Drug (OADs) Initiators Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
Non-Diabetes Cohort The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.

Participant Flow:   Overall Study
    Exenatide Initiators   Other Antidiabetic Drug (OADs) Initiators   Non-Diabetes Cohort
STARTED   37097 [1]   620799 [1]   12015600 [1] 
COMPLETED   25719 [2]   234536 [2]   103511 [2] 
NOT COMPLETED   11378   386263   11912089 
<9 months enroll before drug dispensed                11226                263954                11655523 
Dispensing of drug in baseline period                0                120229                256446 
Baseline diagnosis of pancreatic disease                152                2080                120 
[1] STARTED = Number of subjects considered for inclusion in this cohort.
[2] COMPLETED = Group of subjects for whom data in outcome measures is presented.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exenatide Initiators Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
Other Antidiabetic Drug (OADs) Initiators Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
Non-Diabetes Cohort The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
Total Total of all reporting groups

Baseline Measures
   Exenatide Initiators   Other Antidiabetic Drug (OADs) Initiators   Non-Diabetes Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 25719   234536   103511   363766 
Age 
[Units: Participants]
       
<=18 years   54   2982   24963   27999 
Between 18 and 65 years   23496   202317   73622   299435 
>=65 years   2169   29237   4926   36332 
Gender 
[Units: Participants]
       
Female   14381   114960   52444   181785 
Male   11338   119576   51067   181981 
Has a History of Congestive Heart Failure [1] 
[Units: Participants]
 820   8227   315   9362 
[1] Has a History of Congestive Heart Failure
Has a History of Hyperlipidemia [1] 
[Units: Participants]
 19741   127384   13178   160303 
[1] Has a History of Hyperlipidemia
Has a History of Hypertension [1] 
[Units: Participants]
 16336   114593   10121   141050 
[1] Has a History of Hypertension
Has a History of Ischemic Heart Disease [1] 
[Units: Participants]
 3228   24900   1775   29903 
[1] Has a History of Ischemic Heart Disease
Has a History of Myocardial Infarction [1] 
[Units: Participants]
 301   3951   193   4445 
[1] Has a History of Myocardial Infarction
Has a History of Obesity [1] 
[Units: Participants]
 4107   18933   1230   24270 
[1] Has a History of Obesity
Has a History of Peripheral Neuropathy [1] 
[Units: Participants]
 2456   9581   11   12048 
[1] Has a History of Peripheral Neuropathy
Has a History of Renal Impairment/Dialysis [1] 
[Units: Participants]
 961   8257   312   9530 
[1] Has a History of Renal Impairment/Dialysis
Has a History of Retinopathy [1] 
[Units: Participants]
 1279   6693   76   8048 
[1] Has a History of Retinopathy
Has a History of Stroke/Transient Ischemic Attack [1] 
[Units: Participants]
 423   5088   336   5847 
[1] Has a History of Stroke/Transient Ischemic Attack
Has a History of Type 1 Diabetes [1] 
[Units: Participants]
 2794   19368   0   22162 
[1] Has a History of Type 1 Diabetes
Has a History of Type 2 Diabetes [1] 
[Units: Participants]
 21709   138218   0   159927 
[1] Has a History of Type 2 Diabetes


  Outcome Measures
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1.  Primary:   Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Current Use" Period) - Time on Drug Analysis   [ Time Frame: 43 months ]

2.  Primary:   Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among "Recent Use" Period) - Time on Drug Analysis   [ Time Frame: 43 months ]

3.  Primary:   Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Past Use" Period) - Time on Drug Analysis   [ Time Frame: 43 months ]

4.  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   [ Time Frame: 43 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01077323     History of Changes
Other Study ID Numbers: BCA406
Study First Received: February 25, 2010
Results First Received: August 12, 2010
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board