Type 2 Diabetes MellitusPhase 3NCT00813995

A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

A Phase 3 study testing Comparator: Sitagliptin phosphate in people with 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.

Official record

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Trial summary

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin. Read more about this study

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Comparator: Sitagliptin phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 395 participants
Where: No sites listed yet
Study dates: 9 Dec 2008to 9 Aug 2010
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 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 - 78 years of age
Currently on metformin monotherapy

Who cannot join

History of Type 1 diabetes mellitus or ketoacidosis
Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
HIV positive
Pregnant, breast-feeding or planning to become pregnant during the study
User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

About this study

Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Conditions: Type 2 Diabetes Mellitus
Being tested: Comparator: Sitagliptin phosphate, Comparator: Placebo
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.

Comparator: Sitagliptin phosphateDrug
Also called GLUCOPHAGE®
All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.
Comparator: PlaceboDrug
Also called GLUCOPHAGE®
All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Study groups in NCT00813995
Study group	Role	What they receive
Sitagliptin	Experimental	Not described Receives: Drug: Comparator: Sitagliptin phosphate
Placebo	Placebo comparator	Not described Receives: Drug: Comparator: Placebo

What is being measured

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

Change From Baseline in Hemoglobin A1c (A1C) at Week 24
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 24

Secondary outcomes (4)

Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 24
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 24
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Measured: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
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.

9 Dec 20089 Aug 2010

First posted23 Dec 2008 (estimated)
Study start9 Dec 2008
Primary completion9 Aug 2010
Study completion9 Aug 2010

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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 395 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00813995
Sponsor's protocol ID: 0431-074
Other IDs: 2008_601
Status last verified: Apr 2017
First submitted: 19 Dec 2008
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

Publications

Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.
PubMed 22672586

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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
ClinicalTrials.gov ID: NCT00813995
Acronym / sponsor ID: 0431-074
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 395 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 9 Dec 2008 (actual)
Primary completion: 9 Aug 2010 (actual)
Study completion: 9 Aug 2010 (actual)
First posted: 23 Dec 2008 (estimated)
Results: Posted 13 Sep 2011

Clinical summary

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

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: Comparator: Sitagliptin phosphate
Placebo	Placebo comparator	Drug: Comparator: Placebo

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

18 - 78 years of age
Currently on metformin monotherapy

Key exclusion criteria (8 listed)

History of Type 1 diabetes mellitus or ketoacidosis
Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease

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
Comparator: Sitagliptin phosphateAlso: GLUCOPHAGE®All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.	Drug	Sitagliptin
Comparator: PlaceboAlso: GLUCOPHAGE®All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.	Drug	Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Time frame: Baseline and Week 24
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

4 secondary outcomes

Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day
Time frame: Baseline and Week 24
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day
Time frame: Baseline and Week 24
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 13 Sep 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	197	174
Placebo	198	182

Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) at Week 24

Time frame: Baseline and Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin n = 191	Placebo n = 194
Value	-1.02 (0.99)	-0.14 (1.22)

Sitagliptin vs Placebo: p <.001, ANCOVA

Population analysed: Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \[randomization\] measurement and a post-randomization measurement) using last observation carried forward for missing data.

4 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
Sitagliptin	7 of 197 (3.6%)	10 of 197 (5.1%)	Not reported
Placebo	5 of 198 (2.5%)	13 of 198 (6.6%)	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.
Derived from this study: PubMed 22672586Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.
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 Type 2 Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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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 Comparator: Sitagliptin phosphate in people with 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 8 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. Some participants in this study may receive a placebo. 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 13 Sep 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?

Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (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 NCT00813995, 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 12 May 2017.