Type 2 Diabetes MellitusPhase 3NCT00541775

Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

A Phase 3 study testing Sitagliptin, Comparator: Rosiglitazone and Comparator: Metformin 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

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Sitagliptin, Comparator: Rosiglitazone and Comparator: Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 273 participants
Where: No sites listed yet
Study dates: Jun 2006to Mar 2007
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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patient has Type 2 diabetes
Currently taking metformin >1500 mg/day for at least 10 weeks
Male or female

Who cannot join

Patient has peripheral edema
History of type 1 diabetes
Patient required insulin within prior 8 weeks
Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
Participating in a weight loss program

About this study

Official title: A Multicenter, Double-Blind, Placebo and Active 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

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

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

SitagliptinDrug
Also called Januvia
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
Comparator: RosiglitazoneDrug
Also called Avandia
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
Comparator: PlaceboDrug
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
Comparator: MetforminDrug
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.

Study groups in NCT00541775
Study group	Role	What they receive
Sitagliptin	Experimental	sitagliptin 100 mg Receives: Drug: Sitagliptin; Drug: Comparator: Metformin
Rosiglitazone	Active comparator	rosiglitazone 8 mg Receives: Drug: Comparator: Rosiglitazone; Drug: Comparator: Metformin
Placebo	Placebo comparator	placebo Receives: Drug: Comparator: Placebo; Drug: Comparator: Metformin

What is being measured

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

Hemoglobin A1C (A1C) at Week 18
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
The study hypothesis comparison was between sitagliptin versus placebo.
Measured: Baseline and 18 Weeks

Secondary outcomes (2)

Fasting Plasma Glucose (FPG) at Week 18
The change from baseline is the Week 18 FPG minus the Week 0 FPG.
Measured: Baseline and 18 Weeks
2-hour Post-meal Glucose (PMG) at Week 18
The change from baseline is the Week 18 PMG minus the Week 0 PMG.
Measured: Baseline and 18 Weeks

Timeline

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

Jun 2006Mar 2007

First posted10 Oct 2007 (estimated)
Study startJun 2006
Primary completionMar 2007
Study completionMar 2007

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: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00541775
Sponsor's protocol ID: 0431-801
Other IDs: 2007_623
Status last verified: Aug 2015
First submitted: 5 Oct 2007
Last updated: 24 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.
PubMed 18201203

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 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Placebo and Active 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: NCT00541775
Acronym / sponsor ID: 0431-801
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 273 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 10 Oct 2007 (estimated)
Results: Posted 17 Jun 2010

Clinical summary

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

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Sitagliptin	Experimental	Drug: Sitagliptin, Drug: Comparator: Metforminsitagliptin 100 mg
Rosiglitazone	Active comparator	Drug: Comparator: Rosiglitazone, Drug: Comparator: Metforminrosiglitazone 8 mg
Placebo	Placebo comparator	Drug: Comparator: Placebo, Drug: Comparator: Metforminplacebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has Type 2 diabetes
Currently taking metformin >1500 mg/day for at least 10 weeks
Male or female

Key exclusion criteria (5 listed)

Patient has peripheral edema
History of type 1 diabetes
Patient required insulin within prior 8 weeks
Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
Participating in a weight loss program

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
SitagliptinAlso: JanuviaSitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.	Drug	Sitagliptin
Comparator: RosiglitazoneAlso: AvandiaRosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.	Drug	Rosiglitazone
Comparator: Placeboplacebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.	Drug	Placebo
Comparator: MetforminOpen-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.	Drug	Placebo, Rosiglitazone, Sitagliptin

Primary outcome

Hemoglobin A1C (A1C) at Week 18
Time frame: Baseline and 18 Weeks
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.

2 secondary outcomes

Fasting Plasma Glucose (FPG) at Week 18
Time frame: Baseline and 18 Weeks
2-hour Post-meal Glucose (PMG) at Week 18
Time frame: Baseline and 18 Weeks

Results and safety

Results posted to the registry on 17 Jun 2010, 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	94	85
Rosiglitazone	87	85
Placebo	92	84

Primary outcome: Hemoglobin A1C (A1C) at Week 18

Time frame: Baseline and 18 Weeks. Least squares mean (95% Confidence Interval). Unit: Percent of glycosylated hemoglobin (A1C)

Measure	Sitagliptin n = 91	Rosiglitazone n = 87	Placebo n = 88
Value	-0.73 (-0.87 to -0.60)	-0.79 (-0.92 to -0.65)	-0.22 (-0.36 to -0.08)

Sitagliptin vs Placebo: Mean Difference (Net): -0.51 (95% CI -0.70 to -0.32), p <=0.001, ANCOVA

Population analysed: The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0 to 18. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	5 of 94 (5.3%)	5 of 94 (5.3%)	Not reported
Rosiglitazone	5 of 87 (5.7%)	1 of 87 (1.1%)	Not reported
Placebo	5 of 91 (5.5%)	0 of 91 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18201203Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.

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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
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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, Comparator: Rosiglitazone and Comparator: Metformin 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 3 inclusion and 5 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 24 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. 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 17 Jun 2010). 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 (A1C) at Week 18 (time frame: Baseline and 18 Weeks). 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 NCT00541775, 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 24 Aug 2015.