Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns

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 descriptive analyses conducted within a cohort of patients using linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, and other oral and non-insulin injected hypoglycemic medications between May 2011 and July 2012. 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: 615,067 participants
Where: 1 siteUnited States
Study dates: May 2014to Aug 2014
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 years or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Who may be able to join

diagnosis of type 2 diabetes mellitus
a dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
at least 6 months enrolment in the database preceding the date of the first dispensing

Who cannot join

age < 18
missing or ambiguous age or sex information
at least one diagnosis of type 1 diabetes mellitus or secondary diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

1218.161.1 Boehringer Ingelheim Investigational Site
Boston, Massachusetts

Other trials in United States

About this study

Official title: A Description of Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns Including Initiation, Switching, and Discontinuation

Understanding 1) the existing utilization patterns for linagliptin, sitagliptin, saxagliptin, and other oral and non-insulin injected hypoglycemic agents and (2) the differences in utilization patterns between these agents will help with the design, analysis and interpretation of comparative effectiveness and safety studies of linagliptin, other DPP-4 inhibitors, and other agents.

The study will provide an overview of existing utilization patterns for linagliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, other oral and non-insulin injected hypoglycemic agents, in order to detect potential selective prescribing patterns that might lead to channeling bias.

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 NCT02138097
Study group	Role	What they receive
Glitazones		Not described
Linagliptin		Not described
Meglitinides		Not described
Metformin		Not described
Non-insulin injectables		Not described
Saxagliptin		Not described
Sitagliptin		Not described
Sulfonylurea		Not described

What is being measured

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

Proportion of Initiators for United Healthcare Patients
Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.
Measured: up to 12 months
Proportion of Initiators for MarketScan Patients
Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.
Measured: up to 12 months
Treatment Switching for United Healthcare Patients
Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days
Measured: up to 12 months
Treatment Switching for MarketScan Patients
Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days
Measured: up to 12 months
Treatment Augmentation for United Healthcare Patients
Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy
Measured: up to 12 months
Treatment Augmentation for MarketScan Patients
Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy
Measured: up to 12 months
Subsequent Insulin Initiation for United Healthcare Patients
Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months
Measured: up to 12 months
Subsequent Insulin Initiation for MarketScan Patients
Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months
Measured: up to 12 months

Secondary outcomes (10)

Treatment Discontinuation for United Healthcare Patients
Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)
Measured: up to 12 months
Treatment Discontinuation for Marketscan Patients
Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)
Measured: up to 12 months
Proportion of Days Covered for United Healthcare Patients
Number of days supply dispensed divided by number of days followed
Measured: up to 12 months
Proportion of Days Covered for MarketScan Patients
Number of days supply dispensed divided by number of days followed
Measured: up to 12 months
Persistence at 3 Months for United Healthcare Patients
Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.
Measured: 3 months
Persistence at 6 Months for United Healthcare Patients
Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.
Measured: 6 months
Persistence at 12 Months for United Healthcare Patients
Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.
Measured: 12 months
Persistence at 3 Months for MarketScan Patients
Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.
Measured: 3 months
Persistence at 6 Months for MarketScan Patients
Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.
Measured: 6 months
Persistence at 12 Months for MarketScan Patients
Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.
Measured: 12 months

Timeline

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

May 2014Aug 2014

First posted14 May 2014 (estimated)
Study startMay 2014
Primary completionJul 2014
Study completionAug 2014

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: 615,067 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02138097
Sponsor's protocol ID: 1218.161
Status last verified: Sep 2015
First submitted: 13 May 2014
Last updated: 6 Oct 2015
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 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Description of Oral and Non-insulin Injected Hypoglycemic Therapy Utilization Patterns Including Initiation, Switching, and Discontinuation
ClinicalTrials.gov ID: NCT02138097
Acronym / sponsor ID: 1218.161
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 615,067 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: May 2014
Primary completion: Jul 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 14 May 2014 (estimated)
Results: Posted 6 Oct 2015

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: 8

Arm	Type	Receives
Glitazones	–	–
Linagliptin	–	–
Meglitinides	–	–
Metformin	–	–
Non-insulin injectables	–	–
Saxagliptin	–	–
Sitagliptin	–	–
Sulfonylurea	–	–

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 years or older, initiating antidiabetic treatment after at least 6 months of continuous enrollment

Key inclusion criteria (3 listed)

diagnosis of type 2 diabetes mellitus
a dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
at least 6 months enrolment in the database preceding the date of the first dispensing

Key exclusion criteria (3 listed)

age < 18
missing or ambiguous age or sex information
at least one diagnosis of type 1 diabetes mellitus or 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

Proportion of Initiators for United Healthcare Patients
Time frame: up to 12 months
Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.
Proportion of Initiators for MarketScan Patients
Time frame: up to 12 months
Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.
Treatment Switching for United Healthcare Patients
Time frame: up to 12 months
Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days
Treatment Switching for MarketScan Patients
Time frame: up to 12 months
Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days
Treatment Augmentation for United Healthcare Patients
Time frame: up to 12 months
Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy
Treatment Augmentation for MarketScan Patients
Time frame: up to 12 months
Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy
Subsequent Insulin Initiation for United Healthcare Patients
Time frame: up to 12 months
Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months
Subsequent Insulin Initiation for MarketScan Patients
Time frame: up to 12 months
Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months

10 secondary outcomes

Treatment Discontinuation for United Healthcare Patients
Time frame: up to 12 months
Treatment Discontinuation for Marketscan Patients
Time frame: up to 12 months
Proportion of Days Covered for United Healthcare Patients
Time frame: up to 12 months
Proportion of Days Covered for MarketScan Patients
Time frame: up to 12 months
Persistence at 3 Months for United Healthcare Patients
Time frame: 3 months
Persistence at 6 Months for United Healthcare Patients
Time frame: 6 months
Persistence at 12 Months for United Healthcare Patients
Time frame: 12 months
Persistence at 3 Months for MarketScan Patients
Time frame: 3 months
Persistence at 6 Months for MarketScan Patients
Time frame: 6 months
Persistence at 12 Months for MarketScan Patients
Time frame: 12 months

Results and safety

Results posted to the registry on 6 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
United Healthcare	155,345	155,345
MarketScan	459,722	459,722

Primary outcome: Proportion of Initiators for United Healthcare Patients

Time frame: up to 12 months. Number. Unit: Percentage of participants

Measure	Glitazones n = 7203	Linagliptin n = 2820	Meglitinides n = 1184	Metformin n = 72694	Saxagliptin n = 8100	Sitagliptin n = 18491	Sulfonylurea n = 33868	Alpha-Glucosidase Inhibitors n = 495	GLP-I RA n = 10490
Naive new users	2.8	0.5	0.2	69.9	2.3	5.8	16.3	0.1	2.1
Non-naive new users	6.5	3.1	1.3	23.0	8.2	18.2	27.5	0.5	11.6
Monotherapy	2.4	1.2	0.4	67.4	2.5	6.0	15.9	0.2	4.1
Dual Therapy	3.8	1.3	0.3	41.8	6.3	13.6	28.5	0.1	4.3
Other initiation other than mono- or dual therapy	10.0	3.7	2.1	13.0	9.1	21.3	24.5	0.9	15.3

Population analysed: All subjects in the United Healthcare cohort

Primary outcome: Proportion of Initiators for MarketScan Patients

Time frame: up to 12 months. Number. Unit: Percentage of participants

Measure	Glitazones n = 22310	Linagliptin n = 7708	Meglitinides n = 5412	Metformin n = 205213	Saxagliptin n = 24550	Sitagliptin n = 58769	Sulfonylurea n = 104422	Alpha-Glucosidase Inhibitors n = 1918	GLP-I RA n = 29420
Naive new users	3.0	0.4	0.4	69.1	2.1	5.9	17.2	0.1	1.6
Non-naive new users	6.5	2.8	1.9	23.2	8.1	18.8	27.5	0.7	10.6
Monotherapy	2.5	1.0	0.6	66.1	2.6	6.3	17.4	0.2	3.4
Dual Therapy	5.1	1.7	1.0	34.0	6.6	15.6	29.7	0.3	5.8
Other initiation other than mono- or dual therapy	9.6	3.0	2.7	16.9	9.0	21.8	21.4	1.1	14.5

Population analysed: All subjects in MarketScan cohort

Primary outcome: Treatment Switching for United Healthcare Patients

Time frame: up to 12 months. Number. Unit: participants/1000 participant years

Measure	Glitazones n = 7203	Linagliptin n = 2820	Meglitinides n = 1184	Metformin n = 72694	Saxagliptin n = 8100	Sitagliptin n = 18491	Sulfonylurea n = 33868	Other DPP-4I n = 25940	Alpha-Glucosidase Inhibitors n = 495	GLP-I RA n = 10490
Value	117.76	71.64	122.97	30.47	57.38	103.09	46.89	87.6	126.83	77.9

Population analysed: All subjects in United Healthcare cohort

Primary outcome: Treatment Switching for MarketScan Patients

Time frame: up to 12 months. Number. Unit: participants/1000 participant years

Measure	Glitazones n = 22310	Linagliptin n = 7708	Meglitinides n = 5412	Metformin n = 205213	Saxagliptin n = 24550	Sitagliptin n = 58769	Sulfonylurea n = 104422	Other DPP-4I n = 81760	Alpha-Glucosidase Inhibitors n = 1918	GLP-I RA n = 29420
Value	110.35	72.48	96.88	27.81	60.31	52.25	40.87	54.33	102.9	67.1

Population analysed: All subjects in MarketScan cohort

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glitazones	0 of 0	0 of 0	Not reported
Linagliptin	0 of 0	0 of 0	Not reported
Meglitinides	0 of 0	0 of 0	Not reported
Metformin	0 of 0	0 of 0	Not reported
Saxagliptin	0 of 0	0 of 0	Not reported
Sitagliptin	0 of 0	0 of 0	Not reported
Sulfonylurea	0 of 0	0 of 0	Not reported
Other DPP-4I	0 of 0	0 of 0	Not reported
Alpha-Glucosidase Inhibitors	0 of 0	0 of 0	Not reported
GLP-I RA	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 6 Oct 2015.
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.

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 3 inclusion and 3 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 6 Oct 2015. 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 6 Oct 2015). 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?

Proportion of Initiators for United Healthcare Patients (time frame: up to 12 months). The study lists 8 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 NCT02138097.

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 6 Oct 2015; AzTrials last refreshed its copy on 29 Oct 2026.