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):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01077323
First received: February 25, 2010
Last updated: October 31, 2013
Last verified: October 2013
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  
Number of Participants  
[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  
[units: participants]
  820     8227     315     9362  
Has a History of Hyperlipidemia  
[units: participants]
  19741     127384     13178     160303  
Has a History of Hypertension  
[units: participants]
  16336     114593     10121     141050  
Has a History of Ischemic Heart Disease  
[units: participants]
  3228     24900     1775     29903  
Has a History of Myocardial Infarction  
[units: participants]
  301     3951     193     4445  
Has a History of Obesity  
[units: participants]
  4107     18933     1230     24270  
Has a History of Peripheral Neuropathy  
[units: participants]
  2456     9581     11     12048  
Has a History of Renal Impairment/Dialysis  
[units: participants]
  961     8257     312     9530  
Has a History of Retinopathy  
[units: participants]
  1279     6693     76     8048  
Has a History of Stroke/Transient Ischemic Attack  
[units: participants]
  423     5088     336     5847  
Has a History of Type 1 Diabetes  
[units: participants]
  2794     19368     0     22162  
Has a History of Type 2 Diabetes  
[units: participants]
  21709     138218     0     159927  



  Outcome Measures
  Show All Outcome Measures

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


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
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: October 31, 2013
Health Authority: United States: Institutional Review Board