Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00545584

Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

A Phase 3 study testing sitagliptin phosphate, Comparator: Diet and Comparator: Physical Activity in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three strategies of lifestyle changes was expected. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?: sitagliptin phosphate, Comparator: Diet and Comparator: Physical Activity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,512 participants
Where: No sites listed yet
Study dates: 1 Apr 2007to 19 Nov 2009
Phase: Phase 3
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

Who may be able to join

Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)

Who cannot join

Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
Known hypersensitivity or contraindication to metformin

About this study

Official title: Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Being tested: sitagliptin phosphate, Comparator: Diet, Comparator: Physical Activity
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.

sitagliptin phosphateDrug
sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
Comparator: DietBehavioural
Diet
Comparator: Physical ActivityBehavioural
Physical Activity

Study groups in NCT00545584
Study group	Role	What they receive
Sitagliptin with Standard of Care	Experimental	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet. Receives: Drug: sitagliptin phosphate
Sitagliptin with Diet Advice	Experimental	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary Receives: Drug: sitagliptin phosphate; Behavioral: Comparator: Diet
Sitagliptin with Diet and Physical Activity Advice	Experimental	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week. Receives: Drug: sitagliptin phosphate; Behavioral: Comparator: Diet; Behavioral: Comparator: Physical Activity

What is being measured

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

Hemoglobin A1c Measurement
Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.
Measured: Baseline and Week 24

Secondary outcomes (1)

Fasting Plasma Glucose (FPG) Measurement
Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).
Measured: Baseline and Week 24

Timeline

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

1 Apr 200719 Nov 2009

First posted17 Oct 2007 (estimated)
Study start1 Apr 2007
Primary completion19 Nov 2009
Study completion19 Nov 2009

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, Non-Insulin-DependentStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,512 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00545584
Sponsor's protocol ID: 0431-078
Other IDs: 2007_023
Status last verified: Apr 2017
First submitted: 16 Oct 2007
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

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 Diabetes Mellitus, Non-Insulin-Dependent trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
ClinicalTrials.gov ID: NCT00545584
Acronym / sponsor ID: 0431-078
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,512 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Apr 2007 (actual)
Primary completion: 19 Nov 2009 (actual)
Study completion: 19 Nov 2009 (actual)
First posted: 17 Oct 2007 (estimated)
Results: Posted 11 May 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Sitagliptin with Standard of Care	Experimental	Drug: sitagliptin phosphateSubjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
Sitagliptin with Diet Advice	Experimental	Drug: sitagliptin phosphate, Behavioral: Comparator: DietSubjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary
Sitagliptin with Diet and Physical Activity Advice	Experimental	Drug: sitagliptin phosphate, Behavioral: Comparator: Diet, Behavioral: Comparator: Physical ActivitySubjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)

Key exclusion criteria (3 listed)

Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
Known hypersensitivity or contraindication to metformin

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 phosphatesitagliptin 100 mg once daily. Duration of treatment: 26 Weeks	Drug	Sitagliptin with Diet Advice, Sitagliptin with Diet and Physical Activity Advice, Sitagliptin with Standard of Care
Comparator: DietDiet	Behavioural	Sitagliptin with Diet Advice, Sitagliptin with Diet and Physical Activity Advice
Comparator: Physical ActivityPhysical Activity	Behavioural	Sitagliptin with Diet and Physical Activity Advice

Primary outcome

Hemoglobin A1c Measurement
Time frame: Baseline and Week 24
Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.

1 secondary outcome

Fasting Plasma Glucose (FPG) Measurement
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 11 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin With Standard of Care	412	333
Sitagliptin With Diet Advice	414	334
Sitagliptin With Diet and Physical Activity Advice	306	250

Primary outcome: Hemoglobin A1c Measurement

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: percent HbA1c

Measure	Sitagliptin With Standard of Care n = 362	Sitagliptin With Diet Advice n = 358	Sitagliptin With Diet and Physical Activity Advice n = 265
Baseline (n=360, 358, and 265, respectively)	7.37 (0.61)	7.50 (0.66)	7.49 (0.60)
Week 24 (n=362, 358, and 265, respectively)	7.33 (1.09)	7.42 (1.15)	7.40 (1.07)

Population analysed: The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin. In the Standard of Care group, only 360 subjects had HbA1c Baseline evaluations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This safety data includes AEs and SAEs that occurred during treatment (Visit 2 to Visit 4).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin With Standard of Care	8 of 412 (1.9%)	0 of 412 (0%)	Not reported
Sitagliptin With Diet Advice	18 of 414 (4.3%)	0 of 414 (0%)	Not reported
Sitagliptin With Diet and Physical Activity Advice	7 of 305 (2.3%)	0 of 305 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Diabetes Mellitus, Non-Insulin-Dependent

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sitagliptin phosphate, Comparator: Diet and Comparator: Physical Activity in people with Diabetes Mellitus, Non-Insulin-Dependent, 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 1 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 12 May 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2011). 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?

Hemoglobin A1c Measurement (time frame: Baseline and Week 24). 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 NCT00545584.

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 12 May 2017.