Type 2 Diabetes MellitusSIRTANCT01409213

A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199)

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

The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
How many people: 1,523 participants
Where: No sites listed yet
Study dates: Aug 2009to Jan 2011
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: Participants with type 2 diabetes mellitus being treated in an office setting with metformin at the individual maximal tolerated dose (at least four weeks on stable dose) and had a resultant HbA1c >6.5% were selected for this study. The first five eligible participants per site with type 2 diabetes mellitus and treatment with metformin were to be enrolled.

Who may be able to join

Newly diagnosed with Type 2 diabetes in whom treatment with metformin in
the individual maximal tolerated dose (at least four weeks on stable dose) resulted in
HbA1c >6.5%
No contraindication or intolerability to metformin

Who cannot join

Currently being administered a combination therapy for the treatment of their Type 2 diabetes

About this study

Official title: Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)

Conditions: Type 2 Diabetes Mellitus
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 NCT01409213
Study group	Role	What they receive
All Enrolled Participants		Not described

What is being measured

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

Change From Baseline for Mean Hemoglobin A1c (HbA1C)
Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.
Measured: Baseline and end of Observation (up to Month 6)
Change From Baseline for Mean Fasting Blood Glucose (FBG)
Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.
Measured: Baseline and end of Observation (up to Month 6)

Timeline

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

Aug 2009Jan 2011

First posted4 Aug 2011 (estimated)
Study startAug 2009
Primary completionJan 2011
Study completionJan 2011

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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,523 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01409213
Sponsor's protocol ID: 0431-199
Acronym: SIRTA
Status last verified: Aug 2015
First submitted: 2 Aug 2011
Last updated: 27 Aug 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

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
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)
ClinicalTrials.gov ID: NCT01409213
Acronym / sponsor ID: SIRTA / 0431-199
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 1,523 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 4 Aug 2011 (estimated)
Results: Posted 23 Jan 2012

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: Prospective
Number of arms: 1

Arm	Type	Receives
All Enrolled Participants	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with type 2 diabetes mellitus being treated in an office setting with metformin at the individual maximal tolerated dose (at least four weeks on stable dose) and had a resultant HbA1c >6.5% were selected for this study. The first five eligible participants per site with type 2 diabetes mellitus and treatment with metformin were to be enrolled.

Key inclusion criteria (4 listed)

Newly diagnosed with Type 2 diabetes in whom treatment with metformin in
the individual maximal tolerated dose (at least four weeks on stable dose) resulted in
HbA1c >6.5%
No contraindication or intolerability to metformin

Key exclusion criteria (1 listed)

Currently being administered a combination therapy for the treatment of their Type 2 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

Change From Baseline for Mean Hemoglobin A1c (HbA1C)
Time frame: Baseline and end of Observation (up to Month 6)
Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.
Change From Baseline for Mean Fasting Blood Glucose (FBG)
Time frame: Baseline and end of Observation (up to Month 6)
Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.

Results and safety

Results posted to the registry on 23 Jan 2012, 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 Enrolled Participants	1,523	1,523

Primary outcome: Change From Baseline for Mean Hemoglobin A1c (HbA1C)

Time frame: Baseline and end of Observation (up to Month 6). Mean (Standard Deviation). Unit: Percent of glycosylated hemoglobin

Measure	All Enrolled Participants n = 1522
End of observation, n=1483	6.9 (0.9)
Change from baseline, n=1480	-0.5 (1.0)

Population analysed: Participants from the full analysis set with available data.

Primary outcome: Change From Baseline for Mean Fasting Blood Glucose (FBG)

Time frame: Baseline and end of Observation (up to Month 6). Mean (Standard Deviation). Unit: mg/dL

Measure	All Enrolled Participants n = 1346
End of observation; n=1346	127.8 (34.7)
Change from baseline, n=1244	-18.6 (41.2)

Population analysed: Participants from the full analysis set with available data.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Participants	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 27 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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.

The record lists no contact. Use the official record to reach the sponsor.

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 4 inclusion and 1 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 27 Aug 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 23 Jan 2012). 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?

Change From Baseline for Mean Hemoglobin A1c (HbA1C) (time frame: Baseline and end of Observation (up to Month 6)). 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 NCT01409213.

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 27 Aug 2015.