Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

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 survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination… Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin/metformin
Type of treatment: Pill or oral medicine
How many people: 4,065 participants
Where: No sites listed yet
Study dates: Mar 2009to May 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice

Who may be able to join

Has type 2 diabetes mellitus
Is treated with sitagliptin/metformin within local label for the first time

Who cannot join

Has a contraindication to sitagliptin/metformin according to the local label
Is treated with sitagliptin/metformin before contract and out of enrollment period

About this study

Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice

Conditions: Type 2 Diabetes Mellitus
Being tested: Sitagliptin/metformin
Keywords: Diabetes Mellitus, Non-Insulin-Dependent
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

Sitagliptin/metforminDrug
Also called JANUMET
Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.

Study groups in NCT01065766
Study group	Role	What they receive
All participants		Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin Receives: Drug: Sitagliptin/metformin

What is being measured

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

Percentage of Participants With Any Adverse Experience
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 26 weeks
Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12
HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.
Measured: Baseline and Week 12
Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
Measured: Baseline and Week 12
Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
Measured: Baseline and Week 12
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12
Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Measured: At Week 12
Change From Baseline to Treatment in HbA1c at Week 24
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
Measured: Baseline and Week 24
Change From Baseline to Treatment in FPG at Week 24
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
Measured: Baseline and Week 24
Change From Baseline in 2hr-PPG at Week 24
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
Measured: Baseline and Week 24
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24
Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Measured: At Week 24

Timeline

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

Mar 2009May 2013

First posted9 Feb 2010 (estimated)
Study startMar 2009
Primary completionMay 2013
Study completionMay 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.
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
Time perspective: Prospective
Enrolment: 4,065 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01065766
Sponsor's protocol ID: 0431A-182
Other IDs: 2010_006
Status last verified: Feb 2015
First submitted: 8 Feb 2010
Last updated: 6 Mar 2015
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

Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice
ClinicalTrials.gov ID: NCT01065766
Acronym / sponsor ID: 0431A-182
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Non-Insulin-Dependent
Study type: Observational
Recruitment status: Completed
Enrolment: 4,065 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 Feb 2010 (estimated)
Results: Posted 17 Apr 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

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Drug: Sitagliptin/metforminKorean participants with type 2 diabetes mellitus treated with sitagliptin/metformin

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin in usual practice

Key inclusion criteria (2 listed)

Has type 2 diabetes mellitus
Is treated with sitagliptin/metformin within local label for the first time

Key exclusion criteria (2 listed)

Has a contraindication to sitagliptin/metformin according to the local label
Is treated with sitagliptin/metformin before contract and out of enrollment period

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
Sitagliptin/metforminAlso: JANUMETSitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.	Drug	All participants

Primary outcome

Percentage of Participants With Any Adverse Experience
Time frame: Up to 26 weeks
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12
Time frame: Baseline and Week 12
HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.
Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12
Time frame: Baseline and Week 12
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.
Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12
Time frame: Baseline and Week 12
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12
Time frame: At Week 12
Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.
Change From Baseline to Treatment in HbA1c at Week 24
Time frame: Baseline and Week 24
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.
Change From Baseline to Treatment in FPG at Week 24
Time frame: Baseline and Week 24
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.
Change From Baseline in 2hr-PPG at Week 24
Time frame: Baseline and Week 24
Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.
Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24
Time frame: At Week 24
Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form.

Results and safety

Results posted to the registry on 17 Apr 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
All Participants Included in the Safety Evaluation	4,065	4,033

Primary outcome: Percentage of Participants With Any Adverse Experience

Time frame: Up to 26 weeks. Number. Unit: Percentage of participants

Measure	All Participants Included in the Safety Evaluation n = 4033
Value	3.74

Population analysed: All participants who were included in the safety evaluation

Primary outcome: Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Percentage of glycosylated hemoglobin

Measure	All Participants Included in the Safety Evaluation n = 1597
Value	-0.93 (1.23)

Population analysed: All participants with a pre-treatment and a 12-week post-treatment HbA1c value.

Primary outcome: Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	All Participants Included in the Safety Evaluation n = 1343
Value	-28.21 (42.21)

Population analysed: Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.

Primary outcome: Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: mg/dL

Measure	All Participants Included in the Safety Evaluation n = 1219
Value	-58.02 (72.96)

Population analysed: Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.

Adverse events

Time frame: Up to 26 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants Included in the Safety Evaluation	17 of 4,033 (0.4%)	0 of 4,033 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus

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 Monitor 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 2 inclusion and 2 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 Mar 2015. 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 17 Apr 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?

Percentage of Participants With Any Adverse Experience (time frame: Up to 26 weeks). The study lists 9 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 NCT01065766.

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 Mar 2015.