An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

An observational study of Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Metformin, Sitagliptin and Sulfonylurea
How many people: 3,453 participants
Where: No sites listed yet
Study dates: 15 Jul 2009to 31 Aug 2013
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with type II diabetes mellitus receiving a de novo prescription (for the first time or within less than 8 weeks) for dual therapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.

Who may be able to join

Type 2 diabetes participants
De novo treatment (first prescription or dated within the past 8 weeks) with:
Metformin + sitagliptin dual therapy,
Metformin + sulfonylurea dual therapy,
Sitagliptin as part of another treatment regimen
Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.

Who cannot join

None listed.

About this study

Official title: Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).

Conditions: Type 2 Diabetes Mellitus
Being tested: Metformin, Sitagliptin, Sulfonylurea, Antihyperglycemic Medication
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.

MetforminDrug
SitagliptinDrug
SulfonylureaDrug
Antihyperglycemic MedicationDrug

Study groups in NCT01357135
Study group	Role	What they receive
Metformin + Sitagliptin		Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice. Receives: Drug: Metformin; Drug: Sitagliptin
Metformin + Sulfonylurea		Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride. Receives: Drug: Metformin; Drug: Sulfonylurea
Sitagliptin +/- Other Antihyperglycemic Medication		Participants taking sitagliptin +/- other antihyperglycemic medication (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof. Receives: Drug: Antihyperglycemic Medication

What is being measured

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

Median Duration (in Months) of Initial Dual Therapy
The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.
Measured: Up to 3 years
Percentage of Participants With Strict Changes in Initial Dual Therapy
Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.
Measured: Up to 3 years

Timeline

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

15 Jul 200931 Aug 2013

First posted20 May 2011 (estimated)
Study start15 Jul 2009
Primary completion31 Aug 2013
Study completion31 Aug 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Other
Time perspective: Prospective
Enrolment: 3,453 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01357135
Sponsor's protocol ID: 0431-201
Status last verified: May 2017
First submitted: 18 May 2011
Last updated: 5 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Valensi P, de Pouvourville G, Benard N, Chanut-Vogel C, Kempf C, Eymard E, Moisan C, Dallongeville J. Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study. Diabetes Metab. 2015 Jun;41(3):231-8. doi: 10.1016/j.diabet.2015.03.007. Epub 2015 May 12.
PubMed 25976701

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 Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).
ClinicalTrials.gov ID: NCT01357135
Acronym / sponsor ID: 0431-201
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 3,453 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 15 Jul 2009 (actual)
Primary completion: 31 Aug 2013 (actual)
Study completion: 31 Aug 2013 (actual)
First posted: 20 May 2011 (estimated)
Results: Posted 5 Dec 2014

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: Other
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Metformin + Sitagliptin	–	Drug: Metformin, Drug: SitagliptinParticipants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
Metformin + Sulfonylurea	–	Drug: Metformin, Drug: SulfonylureaParticipants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
Sitagliptin +/- Other Antihyperglycemic Medication	–	Drug: Antihyperglycemic MedicationParticipants taking sitagliptin +/- other antihyperglycemic medication (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with type II diabetes mellitus receiving a de novo prescription (for the first time or within less than 8 weeks) for dual therapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.

Key inclusion criteria (6 listed)

Type 2 diabetes participants
De novo treatment (first prescription or dated within the past 8 weeks) with:
Metformin + sitagliptin dual therapy,
Metformin + sulfonylurea dual therapy,
Sitagliptin as part of another treatment regimen

Key exclusion criteria (0 listed)

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
Metformin	Drug	Metformin + Sitagliptin, Metformin + Sulfonylurea
Sitagliptin	Drug	Metformin + Sitagliptin
Sulfonylurea	Drug	Metformin + Sulfonylurea
Antihyperglycemic Medication	Drug	Sitagliptin +/- Other Antihyperglycemic Medication

Primary outcome

Median Duration (in Months) of Initial Dual Therapy
Time frame: Up to 3 years
The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.
Percentage of Participants With Strict Changes in Initial Dual Therapy
Time frame: Up to 3 years
Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.

Results and safety

Results posted to the registry on 5 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin + Sitagliptin	1,874	1,276
Metformin + Sulfonylurea	733	510
Sitagliptin +/- Other Antihyperglycemic Medication	846	583

Primary outcome: Median Duration (in Months) of Initial Dual Therapy

Time frame: Up to 3 years. Median (95% Confidence Interval). Unit: months

Measure	Metformin + Sitagliptin n = 1874	Metformin + Sulfonylurea n = 733
Value	43.2 (41.4 to NA)	20.2 (17.0 to 25.1)

Population analysed: All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.

Primary outcome: Percentage of Participants With Strict Changes in Initial Dual Therapy

Time frame: Up to 3 years. Number. Unit: Percentage of Participants

Measure	Metformin + Sitagliptin n = 1874	Metformin + Sulfonylurea n = 733
Value	33.1	46.5

Population analysed: All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.

Adverse events

Time frame: Up to 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin + Sitagliptin	68 of 1,874 (3.6%)	0 of 1,874 (0%)	Not reported
Metformin + Sulfonylurea	35 of 733 (4.8%)	0 of 733 (0%)	Not reported
Sitagliptin +/- Other Antihyperglycemic Medication	66 of 846 (7.8%)	0 of 846 (0%)	Not reported

Limitations and caveats (from the sponsor): The adverse events in this study were not systematically collected or assessed and therefore no direct comparison can be made between adverse events in the 3 study groups/arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25976701Valensi P, de Pouvourville G, Benard N, Chanut-Vogel C, Kempf C, Eymard E, Moisan C, Dallongeville J. Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study. Diabetes Metab. 2015 Jun;41(3):231-8. doi: 10.1016/j.diabet.2015.03.007. Epub 2015 May 12.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 6 inclusion and 0 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 5 Jun 2017. 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 5 Dec 2014). 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?

Median Duration (in Months) of Initial Dual Therapy (time frame: Up to 3 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 NCT01357135, which also lists 1 linked publication.

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 5 Jun 2017.