Trial Outcomes & Findings for Epidemiologic Study Of Diabetes And Cancer Risk (NCT NCT02958995)
NCT ID: NCT02958995
Last Updated: 2018-03-07
Results Overview
Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.
Recruitment status
COMPLETED
Target enrollment
2738161 participants
Primary outcome timeframe
15 years
Results posted on
2018-03-07
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 01 July 1997 to 30 June 2011.
Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry (with or without diabetes) and had completed Member Health Survey (MHS) were enrolled in the epidemiology study.
Participant milestones
| Measure |
Full KPNC Cohort
Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
|
Survey Responders Cohort
A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
|
|---|---|---|
|
Overall Study
STARTED
|
2630666
|
107495
|
|
Overall Study
COMPLETED
|
2630666
|
107495
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidemiologic Study Of Diabetes And Cancer Risk
Baseline characteristics by cohort
| Measure |
Full KPNC Cohort
n=2630666 Participants
Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
|
Survey Responders Cohort
n=107495 Participants
A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
|
Total
n=2738161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40 - 49 years
|
1501084 participants
11.6 • n=99 Participants
|
30256 participants
12.9 • n=107 Participants
|
1531340 participants
n=206 Participants
|
|
Age, Customized
50 - 59 years
|
570636 participants
n=99 Participants
|
24585 participants
n=107 Participants
|
595221 participants
n=206 Participants
|
|
Age, Customized
60 - 69 years
|
322517 participants
n=99 Participants
|
25582 participants
n=107 Participants
|
348099 participants
n=206 Participants
|
|
Age, Customized
70 - 79 years
|
170136 participants
n=99 Participants
|
22028 participants
n=107 Participants
|
192164 participants
n=206 Participants
|
|
Age, Customized
greater than or equal to (>=) 80 years
|
66293 participants
n=99 Participants
|
5044 participants
n=107 Participants
|
71337 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1353782 Participants
n=99 Participants
|
54418 Participants
n=107 Participants
|
1408200 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1276884 Participants
n=99 Participants
|
53077 Participants
n=107 Participants
|
1329961 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1339805 Participants
n=99 Participants
|
67837 Participants
n=107 Participants
|
1407642 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
171604 Participants
n=99 Participants
|
10167 Participants
n=107 Participants
|
181771 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
322046 Participants
n=99 Participants
|
11871 Participants
n=107 Participants
|
333917 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
312730 Participants
n=99 Participants
|
13508 Participants
n=107 Participants
|
326238 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
87901 Participants
n=99 Participants
|
2728 Participants
n=107 Participants
|
90629 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
396580 Participants
n=99 Participants
|
1384 Participants
n=107 Participants
|
397964 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 yearsPopulation: Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.
Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.
Outcome measures
| Measure |
Full KPNC Cohort
n=2630666 Participants
Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
|
Survey Responders Cohort
n=107495 Participants
A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
|
|---|---|---|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Kidney/Renal Pelvis, Diabetes Status: No
|
23.5 Incidence per 100,000 person-years
Interval 22.7 to 24.2
|
21.5 Incidence per 100,000 person-years
Interval 17.2 to 25.7
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Kidney/Renal Pelvis, Diabetes Status: Yes
|
39.5 Incidence per 100,000 person-years
Interval 36.8 to 42.2
|
34.5 Incidence per 100,000 person-years
Interval 29.0 to 40.0
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Rectal, Diabetes Status: No
|
24.6 Incidence per 100,000 person-years
Interval 23.8 to 25.4
|
26.7 Incidence per 100,000 person-years
Interval 21.7 to 31.7
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Prostate, Diabetes Status: No
|
380.2 Incidence per 100,000 person-years
Interval 375.6 to 384.9
|
421.9 Incidence per 100,000 person-years
Interval 393.6 to 450.2
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Prostate, Diabetes Status: Yes
|
308.0 Incidence per 100,000 person-years
Interval 299.0 to 316.9
|
281.9 Incidence per 100,000 person-years
Interval 265.7 to 298.2
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Female Breast, Diabetes Status: No
|
291.8 Incidence per 100,000 person-years
Interval 288.2 to 295.5
|
310.7 Incidence per 100,000 person-years
Interval 287.6 to 333.8
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Female Breast, Diabetes Status: Yes
|
286.9 Incidence per 100,000 person-years
Interval 276.3 to 297.5
|
287.9 Incidence per 100,000 person-years
Interval 266.1 to 309.6
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Lung/Bronchus, Diabetes Status: No
|
111.3 Incidence per 100,000 person-years
Interval 109.7 to 113.0
|
116.1 Incidence per 100,000 person-years
Interval 107.0 to 125.3
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Lung/Bronchus, Diabetes Status: Yes
|
108.8 Incidence per 100,000 person-years
Interval 104.9 to 112.6
|
105.9 Incidence per 100,000 person-years
Interval 98.5 to 113.2
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Colon, Diabetes Status: No
|
69.1 Incidence per 100,000 person-years
Interval 67.8 to 70.5
|
75.5 Incidence per 100,000 person-years
Interval 67.9 to 83.1
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Colon, Diabetes Status: Yes
|
93.5 Incidence per 100,000 person-years
Interval 89.7 to 97.3
|
97.3 Incidence per 100,000 person-years
Interval 90.1 to 104.5
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Non-Hodgkin lymphoma, Diabetes: No
|
39.5 Incidence per 100,000 person-years
Interval 38.5 to 40.5
|
40.6 Incidence per 100,000 person-years
Interval 34.6 to 46.6
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Non-Hodgkin lymphoma, Diabetes: Yes
|
45.6 Incidence per 100,000 person-years
Interval 42.8 to 48.4
|
43.2 Incidence per 100,000 person-years
Interval 37.7 to 48.6
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Corpus uteri, Diabetes Status: No
|
55.9 Incidence per 100,000 person-years
Interval 54.3 to 57.5
|
59.7 Incidence per 100,000 person-years
Interval 49.6 to 69.8
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Corpus uteri, Diabetes Status: Yes
|
112.1 Incidence per 100,000 person-years
Interval 104.9 to 119.2
|
106.2 Incidence per 100,000 person-years
Interval 92.7 to 119.6
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Pancreas, Diabetes Status: No
|
18.8 Incidence per 100,000 person-years
Interval 18.1 to 19.5
|
18.5 Incidence per 100,000 person-years
Interval 14.9 to 22.1
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Pancreas, Diabetes Status: Yes
|
47.3 Incidence per 100,000 person-years
Interval 44.6 to 49.9
|
37.1 Incidence per 100,000 person-years
Interval 32.3 to 41.9
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Rectal, Diabetes Status: Yes
|
31.1 Incidence per 100,000 person-years
Interval 28.7 to 33.4
|
31.9 Incidence per 100,000 person-years
Interval 26.6 to 37.2
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Melanoma, Diabetes Status: No
|
42.5 Incidence per 100,000 person-years
Interval 41.5 to 43.5
|
55.8 Incidence per 100,000 person-years
Interval 48.5 to 63.0
|
|
Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Melanoma, Diabetes Status: Yes
|
30.6 Incidence per 100,000 person-years
Interval 28.2 to 32.9
|
31.7 Incidence per 100,000 person-years
Interval 26.8 to 36.7
|
PRIMARY outcome
Timeframe: 15 yearsPopulation: Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.
The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.
Outcome measures
| Measure |
Full KPNC Cohort
n=2630666 Participants
Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
|
Survey Responders Cohort
n=107495 Participants
A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
|
|---|---|---|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Prostate, Diabetes Status
|
0.81 Ratio
Interval 0.78 to 0.83
|
0.77 Ratio
Interval 0.68 to 0.86
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Female Breast, Diabetes Status
|
1.01 Ratio
Interval 0.98 to 1.05
|
0.98 Ratio
Interval 0.86 to 1.12
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Lung/Bronchus, Diabetes Status
|
0.99 Ratio
Interval 0.96 to 1.03
|
0.84 Ratio
Interval 0.74 to 0.96
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Colon, Diabetes Status
|
1.36 Ratio
Interval 1.31 to 1.42
|
1.18 Ratio
Interval 1.01 to 1.38
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Non-Hodgkin lymphoma, Diabetes
|
1.14 Ratio
Interval 1.07 to 1.21
|
1.06 Ratio
Interval 0.85 to 1.33
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Corpus uteri, Diabetes Status
|
1.82 Ratio
Interval 1.71 to 1.95
|
1.67 Ratio
Interval 1.28 to 2.18
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Pancreas, Diabetes Status
|
2.50 Ratio
Interval 2.35 to 2.67
|
2.38 Ratio
Interval 1.78 to 3.18
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Kidney/Renal Pelvis, Diabetes Status
|
1.56 Ratio
Interval 1.46 to 1.67
|
1.37 Ratio
Interval 1.04 to 1.82
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Rectal, Diabetes Status
|
1.25 Ratio
Interval 1.16 to 1.35
|
1.41 Ratio
Interval 1.05 to 1.89
|
|
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Melanoma, Diabetes Status
|
0.73 Ratio
Interval 0.68 to 0.79
|
0.69 Ratio
Interval 0.55 to 0.86
|
Adverse Events
Full KPNC Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Survey Responders 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 No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER