Diabetes Mellitus, Type 2, CancerNCT02958995

Epidemiologic Study Of Diabetes And Cancer Risk

An observational study of Diabetes Mellitus, Type 2, Cancer, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes along with the assessment of association between diabetes severity and cancer risk. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Cancer
How many people: 2,738,161 participants
Where: No sites listed yet
Study dates: 1 Jan 1997to 29 May 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Inclusion Criteria: 1. has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997 and had no prior diagnosis of the cancer of interest.

About this study

Read the detailed description

The study enroll a large population of approximately 252467 participants. This epidemiology study of diabetes and cancer risk is an expansion study which would include estimation of cancer rate among KPNC members with or without diabetes and the relative risks of cancers associated with a diagnosis of diabetes. The study included diabetes participants who were KPNC members between 1997 and 2011. It also included a subset of participants who took the 1996/7 diabetes survey and Member Health Survey (MHS) in 1993, 1999, 2001 or 2003.

This multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. The participants were followed-up from January 1, 1997 up to December 31, 2011.

Conditions: Diabetes Mellitus, Type 2, Cancer
Being tested: No Intervention
Keywords: Drug Therapy
Medical subject headings: Diabetes Mellitus, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No InterventionOther

Study groups in NCT02958995
Study group	Role	What they receive
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. Receives: Other: No Intervention
Survey Responders		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. Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
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.
Measured: 15 years
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
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.
Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 199729 May 2015

First posted8 Nov 2016 (estimated)
Study start1 Jan 1997
Primary completion29 May 2015
Study completion29 May 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2, CancerStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,738,161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02958995
Sponsor's protocol ID: AD-4833_403B
Other IDs: EUPAS10335
Status last verified: Feb 2018
First submitted: 4 Nov 2016
Last updated: 7 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Diabetes Mellitus, Type 2, Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidemiologic Study Of Diabetes And Cancer Risk
ClinicalTrials.gov ID: NCT02958995
Acronym / sponsor ID: AD-4833_403B
Conditions: Diabetes Mellitus, Type 2, Cancer
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 2,738,161 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Jan 1997 (actual)
Primary completion: 29 May 2015 (actual)
Study completion: 29 May 2015 (actual)
First posted: 8 Nov 2016 (estimated)
Results: Posted 10 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Full KPNC Cohort	–	Other: No InterventionParticipants 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	–	Other: No InterventionA 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No Intervention	Other	Full KPNC Cohort, Survey Responders

Primary outcome

Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status
Time frame: 15 years
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.
Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes
Time frame: 15 years
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.

Results and safety

Results posted to the registry on 10 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full KPNC Cohort	2,630,666	2,630,666
Survey Responders Cohort	107,495	107,495

Primary outcome: Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status

Time frame: 15 years. Number (95% Confidence Interval). Unit: Incidence per 100,000 person-years

Measure	Full KPNC Cohort n = 2630666	Survey Responders Cohort n = 107495
Prostate, Diabetes Status: No	380.2 (375.6 to 384.9)	421.9 (393.6 to 450.2)
Prostate, Diabetes Status: Yes	308.0 (299 to 316.9)	281.9 (265.7 to 298.2)
Female Breast, Diabetes Status: No	291.8 (288.2 to 295.5)	310.7 (287.6 to 333.8)
Female Breast, Diabetes Status: Yes	286.9 (276.3 to 297.5)	287.9 (266.1 to 309.6)
Lung/Bronchus, Diabetes Status: No	111.3 (109.7 to 113.0)	116.1 (107.0 to 125.3)
Lung/Bronchus, Diabetes Status: Yes	108.8 (104.9 to 112.6)	105.9 (98.5 to 113.2)
Colon, Diabetes Status: No	69.1 (67.8 to 70.5)	75.5 (67.9 to 83.1)
Colon, Diabetes Status: Yes	93.5 (89.7 to 97.3)	97.3 (90.1 to 104.5)

Population analysed: Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.

Primary outcome: Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes

Time frame: 15 years. Number (95% Confidence Interval). Unit: Ratio

Measure	Full KPNC Cohort n = 2630666	Survey Responders Cohort n = 107495
Prostate, Diabetes Status	0.81 (0.78 to 0.83)	0.77 (0.68 to 0.86)
Female Breast, Diabetes Status	1.01 (0.98 to 1.05)	0.98 (0.86 to 1.12)
Lung/Bronchus, Diabetes Status	0.99 (0.96 to 1.03)	0.84 (0.74 to 0.96)
Colon, Diabetes Status	1.36 (1.31 to 1.42)	1.18 (1.01 to 1.38)
Non-Hodgkin lymphoma, Diabetes	1.14 (1.07 to 1.21)	1.06 (0.85 to 1.33)
Corpus uteri, Diabetes Status	1.82 (1.71 to 1.95)	1.67 (1.28 to 2.18)
Pancreas, Diabetes Status	2.50 (2.35 to 2.67)	2.38 (1.78 to 3.18)
Kidney/Renal Pelvis, Diabetes Status	1.56 (1.46 to 1.67)	1.37 (1.04 to 1.82)

Population analysed: Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full KPNC Cohort	0 of 0	0 of 0	Not reported
Survey Responders Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, Cancer, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status (time frame: 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02958995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.