Diabetes Mellitus, Type 2NCT02197078

Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in United States.

Completed

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

Trial summary

This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
How many people: 189,426 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2014to 26 Feb 2019
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Who may be able to join

A dispensing of an oral hypoglycemic medication
A diagnosis of type 2 diabetes mellitus (T2DM)

Who cannot join

less than 18 years old
missing or ambiguous age or sex information
at least one diagnosis of type 1 diabetes mellitus
less than 6 months enrolment in the database preceding the date of the first dispensing
secondary diabetes
history of cancer

Show all 9Show fewer

end-stage renal disease (ESRD)
HIV
organ transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02120

Other trials in United States

About this study

Conditions: Diabetes Mellitus, Type 2
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

Study groups in NCT02197078
Study group	Role	What they receive
Glitazones		Not described
Linagliptin		Not described
Sulfonylurea		Not described
Within-class comparators		Not described

What is being measured

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

Number of Participants With Major Adverse Cardiovascular Event
Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:
- Coronary revascularization (elective and non-elective procedure)
- Acute coronary syndrome (ACS), including acute myocardial infarction (MI)
- Stroke (Ischemic and hemorrhagic stroke)
Measured: Up to 5 years and 7 months
Number of Participants With Coronary Revascularization
Number of participants with coronary revascularization (elective and non-elective procedure)
Measured: Up to 5 years and 7 month
Number of Participants With Acute Coronary Syndrome
Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.
Measured: Up to 5 years and 7 months
Number of Participants With Stroke
Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately
Measured: Up to 5 years and 7 months

Secondary outcomes (4)

Number of Participants With Heart Failure Hospitalization
Number of participants with heart failure hospitalization
Measured: Up to 5 years and 7 months
Number of Participants With Incident End Stage Renal Disease
Number of participants with incident end stage renal disease (ESRD)
Measured: Up to 5 years and 7 months
Number of Participants With Acute Renal Failure
Number of participants with acute renal failure
Measured: Up to 5 years and 7 months
Number of Participants With Acute Renal Failure Requiring Dialysis
Number of patients with acute renal failure requiring dialysis
Measured: Up to 5 years and 7 months

Timeline

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

30 Jul 201426 Feb 2019

First posted22 Jul 2014 (estimated)
Study start30 Jul 2014
Primary completion26 Feb 2019
Study completion26 Feb 2019

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 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Retrospective
Enrolment: 189,426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02197078
Sponsor's protocol ID: 1218.163
Status last verified: Mar 2020
First submitted: 21 Jul 2014
Last updated: 2 Apr 2020
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
ClinicalTrials.gov ID: NCT02197078
Acronym / sponsor ID: 1218.163
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 189,426 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 30 Jul 2014 (actual)
Primary completion: 26 Feb 2019 (actual)
Study completion: 26 Feb 2019 (actual)
First posted: 22 Jul 2014 (estimated)
Results: Posted 2 Apr 2020

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Glitazones	–	–
Linagliptin	–	–
Sulfonylurea	–	–
Within-class comparators	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: T2DM patients aged 18 or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Key inclusion criteria (2 listed)

A dispensing of an oral hypoglycemic medication
A diagnosis of type 2 diabetes mellitus (T2DM)

Key exclusion criteria (9 listed)

less than 18 years old
missing or ambiguous age or sex information
at least one diagnosis of type 1 diabetes mellitus
less than 6 months enrolment in the database preceding the date of the first dispensing
secondary diabetes

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

Primary outcome

Number of Participants With Major Adverse Cardiovascular Event
Time frame: Up to 5 years and 7 months
Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of: * Coronary revascularization (elective and non-elective procedure) * Acute coronary syndrome (ACS), including acute myocardial infarction (MI) * Stroke (Ischemic and hemorrhagic stroke)
Number of Participants With Coronary Revascularization
Time frame: Up to 5 years and 7 month
Number of participants with coronary revascularization (elective and non-elective procedure)
Number of Participants With Acute Coronary Syndrome
Time frame: Up to 5 years and 7 months
Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.
Number of Participants With Stroke
Time frame: Up to 5 years and 7 months
Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately

4 secondary outcomes

Number of Participants With Heart Failure Hospitalization
Time frame: Up to 5 years and 7 months
Number of Participants With Incident End Stage Renal Disease
Time frame: Up to 5 years and 7 months
Number of Participants With Acute Renal Failure
Time frame: Up to 5 years and 7 months
Number of Participants With Acute Renal Failure Requiring Dialysis
Time frame: Up to 5 years and 7 months

Results and safety

Results posted to the registry on 2 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Other DPP-4I - Clinformatics	14,688	14,688
Linagliptin 1 - Clinformatics	14,688	14,688
Pioglitazone - Clinformatics	10,614	10,614
Linagliptin 2 - Clinformatics	10,614	10,614
2nd Gen SUs - Clinformatics	9,538	9,538
Linagliptin 3 - Clinformatics	9,538	9,538
Other DPP-4I - MarketScan	25,135	25,135
Linagliptin 1 - MarketScan	25,135	25,135
Pioglitazone - MarketScan	18,996	18,996
Linagliptin 2 - MarketScan	18,996	18,996
2nd Gen SUs - MarketScan	15,742	15,742
Linagliptin 3 - MarketScan	15,742	15,742

Primary outcome: Number of Participants With Major Adverse Cardiovascular Event

Time frame: Up to 5 years and 7 months. Number. Unit: Participants

Measure	Other DPP-4I - Clinformatics n = 14688	Linagliptin 1 - Clinformatics n = 14688	Pioglitazone - Clinformatics n = 10614	Linagliptin 2 - Clinformatics n = 10614	2nd Gen SUs - Clinformatics n = 9538	Linagliptin 3 - Clinformatics n = 9538	Other DPP-4I - MarketScan n = 25135	Linagliptin 1 - MarketScan n = 25135	Pioglitazone - MarketScan n = 18996	Linagliptin 2 - MarketScan n = 18996	2nd Gen SUs - MarketScan n = 15742	Linagliptin 3 - MarketScan n = 15742
Value	165	151	120	102	127	82	403	369	262	270	259	194

Other DPP-4I - Clinformatics vs Linagliptin 1 - Clinformatics: Hazard Ratio (HR): 0.82 (95% CI 0.66 to 1.03)
Pioglitazone - Clinformatics vs Linagliptin 2 - Clinformatics: Hazard Ratio (HR): 0.85 (95% CI 0.65 to 1.10)
2nd Gen SUs - Clinformatics vs Linagliptin 3 - Clinformatics: Hazard Ratio (HR): 0.65 (95% CI 0.49 to 0.86)

Population analysed: 1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016

Primary outcome: Number of Participants With Coronary Revascularization

Time frame: Up to 5 years and 7 month. Number. Unit: Participants

Measure	Other DPP-4I - Clinformatics n = 14688	Linagliptin 1 - Clinformatics n = 14688	Pioglitazone - Clinformatics n = 10614	Linagliptin 2 - Clinformatics n = 10614	2nd Gen SUs - Clinformatics n = 9538	Linagliptin 3 - Clinformatics n = 9538	Other DPP-4I - MarketScan n = 25135	Linagliptin 1 - MarketScan n = 25135	Pioglitazone - MarketScan n = 18996	Linagliptin 2 - MarketScan n = 18996	2nd Gen SUs - MarketScan n = 15742	Linagliptin 3 - MarketScan n = 15742
Value	82	81	67	54	67	46	181	181	129	133	125	94

Other DPP-4I - Clinformatics vs Linagliptin 1 - Clinformatics: Hazard Ratio (HR): 0.90 (95% CI 0.66 to 1.23)
Pioglitazone - Clinformatics vs Linagliptin 2 - Clinformatics: Hazard Ratio (HR): 0.81 (95% CI 0.57 to 1.16)
2nd Gen SUs - Clinformatics vs Linagliptin 3 - Clinformatics: Hazard Ratio (HR): 0.70 (95% CI 0.48 to 1.01)

Primary outcome: Number of Participants With Acute Coronary Syndrome

Time frame: Up to 5 years and 7 months. Number. Unit: Participants

Measure	Other DPP-4I - Clinformatics n = 14688	Linagliptin 1 - Clinformatics n = 14688	Pioglitazone - Clinformatics n = 10614	Linagliptin 2 - Clinformatics n = 10614	2nd Gen SUs - Clinformatics n = 9538	Linagliptin 3 - Clinformatics n = 9538	Other DPP-4I - MarketScan n = 25135	Linagliptin 1 - MarketScan n = 25135	Pioglitazone - MarketScan n = 18996	Linagliptin 2 - MarketScan n = 18996	2nd Gen SUs - MarketScan n = 15742	Linagliptin 3 - MarketScan n = 15742
Value	93	72	76	48	72	43	238	221	163	160	161	115

Other DPP-4I - Clinformatics vs Linagliptin 1 - Clinformatics: Hazard Ratio (HR): 0.69 (95% CI 0.51 to 0.94)
Pioglitazone - Clinformatics vs Linagliptin 2 - Clinformatics: Hazard Ratio (HR): 0.63 (95% CI 0.44 to 0.90)
2nd Gen SUs - Clinformatics vs Linagliptin 3 - Clinformatics: Hazard Ratio (HR): 0.60 (95% CI 0.41 to 0.88)

Primary outcome: Number of Participants With Stroke

Time frame: Up to 5 years and 7 months. Number. Unit: Participants

Measure	Other DPP-4I - Clinformatics n = 14688	Linagliptin 1 - Clinformatics n = 14688	Pioglitazone - Clinformatics n = 10614	Linagliptin 2 - Clinformatics n = 10614	2nd Gen SUs - Clinformatics n = 9538	Linagliptin 3 - Clinformatics n = 9538	Other DPP-4I - MarketScan n = 25135	Linagliptin 1 - MarketScan n = 25135	Pioglitazone - MarketScan n = 18996	Linagliptin 2 - MarketScan n = 18996	2nd Gen SUs - MarketScan n = 15742	Linagliptin 3 - MarketScan n = 15742
Value	42	42	30	30	37	16	113	104	66	74	76	53

Other DPP-4I - Clinformatics vs Linagliptin 1 - Clinformatics: Hazard Ratio (HR): 0.89 (95% CI 0.58 to 1.38)
Pioglitazone - Clinformatics vs Linagliptin 2 - Clinformatics: Hazard Ratio (HR): 0.99 (95% CI 0.60 to 1.64)
2nd Gen SUs - Clinformatics vs Linagliptin 3 - Clinformatics: Hazard Ratio (HR): 0.44 (95% CI 0.24 to 0.78)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Other DPP-4I - Clinformatics	0 of 0	0 of 0
Linagliptin 1 - Clinformatics	0 of 0	0 of 0
Pioglitazone - Clinformatics	0 of 0	0 of 0
Linagliptin 2 - Clinformatics	0 of 0	0 of 0
2nd Gen SUs - Clinformatics	0 of 0	0 of 0
Linagliptin 3 - Clinformatics	0 of 0	0 of 0
Other DPP-4I - MarketScan	0 of 0	0 of 0
Linagliptin 1 - MarketScan	0 of 0	0 of 0
Pioglitazone - MarketScan	0 of 0	0 of 0
Linagliptin 2 - MarketScan	0 of 0	0 of 0
2nd Gen SUs - MarketScan	0 of 0	0 of 0
Linagliptin 3 - MarketScan	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Pioglitazone is contraindicated among patients with heart failure and edema. This suggests pioglitazone may not be a proper comparator in the assessment of the association between linagliptin and heart failure hospitalization or renal outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 Apr 2020). 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?

Number of Participants With Major Adverse Cardiovascular Event (time frame: Up to 5 years and 7 months). The study lists 4 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 NCT02197078.

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 2 Apr 2020.