Trial Outcomes & Findings for A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents (NCT NCT01077323)
NCT ID: NCT01077323
Last Updated: 2015-04-15
Results Overview
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."
Recruitment status
COMPLETED
Target enrollment
363766 participants
Primary outcome timeframe
43 months
Results posted on
2015-04-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37097
|
620799
|
12015600
|
|
Overall Study
COMPLETED
|
25719
|
234536
|
103511
|
|
Overall Study
NOT COMPLETED
|
11378
|
386263
|
11912089
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
<9 months enroll before drug dispensed
|
11226
|
263954
|
11655523
|
|
Overall Study
Dispensing of drug in baseline period
|
0
|
120229
|
256446
|
|
Overall Study
Baseline diagnosis of pancreatic disease
|
152
|
2080
|
120
|
Baseline Characteristics
A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents
Baseline characteristics by cohort
| Measure |
Exenatide Initiators
n=25719 Participants
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
n=234536 Participants
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
n=103511 Participants
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
n=363766 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
54 Participants
n=5 Participants
|
2982 Participants
n=7 Participants
|
24963 Participants
n=5 Participants
|
27999 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23496 Participants
n=5 Participants
|
202317 Participants
n=7 Participants
|
73622 Participants
n=5 Participants
|
299435 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2169 Participants
n=5 Participants
|
29237 Participants
n=7 Participants
|
4926 Participants
n=5 Participants
|
36332 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14381 Participants
n=5 Participants
|
114960 Participants
n=7 Participants
|
52444 Participants
n=5 Participants
|
181785 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11338 Participants
n=5 Participants
|
119576 Participants
n=7 Participants
|
51067 Participants
n=5 Participants
|
181981 Participants
n=4 Participants
|
|
Has a History of Congestive Heart Failure
|
820 participants
n=5 Participants
|
8227 participants
n=7 Participants
|
315 participants
n=5 Participants
|
9362 participants
n=4 Participants
|
|
Has a History of Hyperlipidemia
|
19741 participants
n=5 Participants
|
127384 participants
n=7 Participants
|
13178 participants
n=5 Participants
|
160303 participants
n=4 Participants
|
|
Has a History of Hypertension
|
16336 participants
n=5 Participants
|
114593 participants
n=7 Participants
|
10121 participants
n=5 Participants
|
141050 participants
n=4 Participants
|
|
Has a History of Ischemic Heart Disease
|
3228 participants
n=5 Participants
|
24900 participants
n=7 Participants
|
1775 participants
n=5 Participants
|
29903 participants
n=4 Participants
|
|
Has a History of Myocardial Infarction
|
301 participants
n=5 Participants
|
3951 participants
n=7 Participants
|
193 participants
n=5 Participants
|
4445 participants
n=4 Participants
|
|
Has a History of Obesity
|
4107 participants
n=5 Participants
|
18933 participants
n=7 Participants
|
1230 participants
n=5 Participants
|
24270 participants
n=4 Participants
|
|
Has a History of Peripheral Neuropathy
|
2456 participants
n=5 Participants
|
9581 participants
n=7 Participants
|
11 participants
n=5 Participants
|
12048 participants
n=4 Participants
|
|
Has a History of Renal Impairment/Dialysis
|
961 participants
n=5 Participants
|
8257 participants
n=7 Participants
|
312 participants
n=5 Participants
|
9530 participants
n=4 Participants
|
|
Has a History of Retinopathy
|
1279 participants
n=5 Participants
|
6693 participants
n=7 Participants
|
76 participants
n=5 Participants
|
8048 participants
n=4 Participants
|
|
Has a History of Stroke/Transient Ischemic Attack
|
423 participants
n=5 Participants
|
5088 participants
n=7 Participants
|
336 participants
n=5 Participants
|
5847 participants
n=4 Participants
|
|
Has a History of Type 1 Diabetes
|
2794 participants
n=5 Participants
|
19368 participants
n=7 Participants
|
0 participants
n=5 Participants
|
22162 participants
n=4 Participants
|
|
Has a History of Type 2 Diabetes
|
21709 participants
n=5 Participants
|
138218 participants
n=7 Participants
|
0 participants
n=5 Participants
|
159927 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 43 monthsPopulation: Time on Drug Analysis
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."
Outcome measures
| Measure |
Exenatide Initiators
n=25719 Participants
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
n=234536 Participants
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
n=103511 Participants
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.
|
|---|---|---|---|
|
Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Current Use" Period) - Time on Drug Analysis
|
219.7 Cases per 100,000 person-years
Interval 155.5 to 301.6
|
226.7 Cases per 100,000 person-years
Interval 205.4 to 249.6
|
56.2 Cases per 100,000 person-years
Interval 43.7 to 71.1
|
PRIMARY outcome
Timeframe: 43 monthsPopulation: Time on Drug Analysis
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."
Outcome measures
| Measure |
Exenatide Initiators
n=25719 Participants
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
n=234536 Participants
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
n=103511 Participants
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.
|
|---|---|---|---|
|
Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among "Recent Use" Period) - Time on Drug Analysis
|
321.4 Cases per 100,000 person-years
Interval 117.9 to 699.5
|
325.5 Cases per 100,000 person-years
Interval 243.8 to 425.7
|
56.2 Cases per 100,000 person-years
Interval 43.7 to 71.1
|
PRIMARY outcome
Timeframe: 43 monthsPopulation: Time on Drug Analysis
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."
Outcome measures
| Measure |
Exenatide Initiators
n=25719 Participants
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
n=234536 Participants
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
n=103511 Participants
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.
|
|---|---|---|---|
|
Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Past Use" Period) - Time on Drug Analysis
|
354.5 Cases per 100,000 person-years
Interval 245.5 to 495.4
|
218.1 Cases per 100,000 person-years
Interval 183.0 to 258.0
|
56.2 Cases per 100,000 person-years
Interval 43.7 to 71.1
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: Intent to Treat Analysis
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.
Outcome measures
| Measure |
Exenatide Initiators
n=25719 Participants
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
n=234536 Participants
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
n=103511 Participants
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.
|
|---|---|---|---|
|
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
|
272.7 Cases per 100,000 person-years
Interval 215.6 to 340.4
|
227.6 Cases per 100,000 person-years
Interval 209.4 to 246.9
|
56.2 Cases per 100,000 person-years
Interval 43.7 to 71.1
|
Adverse Events
Exenatide Initiators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Antidiabetic Drug (OADs) Initiators
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Diabetes Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60