Diabetes Mellitus, Type 2Phase 3NCT00087516

Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

A Phase 3 study testing Sitagliptin (MK0431), Sitagliptin and Metformin - Rescue in people with Diabetes Mellitus, Type 2, 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 clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Sitagliptin (MK0431), Sitagliptin and Metformin - Rescue
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 741 participants
Where: No sites listed yet
Study dates: Jun 2004to Feb 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
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with type 2 diabetes mellitus
Patient is not pregnant or breastfeeding
Male or female patient unlikely to conceive
Patient not on an antihyperglycemic drug

Who cannot join

Patient has history of type 1 diabetes mellitus
Patient has history of ketoacidosis
Patient requires insulin within 8 weeks prior to start of study
Patient on weight loss program and is not in maintenance phase
Patient taking weight loss medication within 8 weeks prior to start of study
Patient on or likely to require = 14 days or repeated courses of corticosteroids

Show all 17Show fewer

Patient taking immunosuppressive/immunomodulating medication
Patient taking digoxin or other cardiac medication
Patient has undergone surgical general anesthesia within 30 days prior to start of study
Patient taking investigational drug within 8 weeks prior to start of study
Patient is diagnosed with liver disease
Patient has chronic myopathy, progressive neurological/neuromuscular disorder
Patient has with severe cardiac conditions within the last 6 months
Patient is Human immunodeficiency virus (HIV) positive
Patient has hematological disorder
Patient has history of malignancy
Patient has history of alcohol or drug abuse within the past 3 years

About this study

Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 2
Being tested: Sitagliptin (MK0431), Sitagliptin, Placebo, Metformin - Rescue
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 (MK0431)Drug
Also called MK0431, Januvia
Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
SitagliptinDrug
Also called MK0431, Januvia
Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
PlaceboDrug
Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
PlaceboDrug
Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Metformin - RescueDrug
Also called Metformin, Glucophage, Glucophage XR, Glumetza
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Study groups in NCT00087516
Study group	Role	What they receive
Sitagliptin 100 mg/100 mg	Active comparator	Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) Receives: Drug: Sitagliptin (MK0431); Drug: Metformin - Rescue
Sitagliptin 200 mg/200 mg	Active comparator	Phase A and B: Oral tablets of sitagliptin 200 mg q.d Receives: Drug: Sitagliptin; Drug: Metformin - Rescue
Placebo/Sitagliptin 100 mg	Placebo comparator	Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. Receives: Drug: Placebo; Drug: Metformin - Rescue
Placebo/Sitagliptin 200 mg	Placebo comparator	Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d. Receives: Drug: Placebo; Drug: Metformin - Rescue

What is being measured

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

Change From Baseline in A1C at Week 24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Measured: Weeks 0-24

Secondary outcomes (5)

Change From Baseline in FPG at Week 24
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Measured: Weeks 0-24
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
Measured: Weeks 0-24
Change From Baseline in A1C at Week 104
A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
Measured: Weeks 0-104
Change From Baseline in FPG at Week 104
Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
Measured: Weeks 0-104
Change From Baseline in 2-hr PMG at Week 104
Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.
Measured: Weeks 0-104

Timeline

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

Jun 2004Feb 2007

First posted13 Jul 2004 (estimated)
Study startJun 2004
Primary completionJul 2005
Study completionFeb 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 Diabetes Mellitus, Type 2Studies 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: 741 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00087516
Sponsor's protocol ID: 0431-021
Other IDs: Formally-C0604MT2D, MK0431-021, 2006_413
Status last verified: Jun 2015
First submitted: 9 Jul 2004
Last updated: 3 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
PubMed 17130196

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, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00087516
Acronym / sponsor ID: 0431-021
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 741 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Jul 2005 (actual)
Study completion: Feb 2007 (actual)
First posted: 13 Jul 2004 (estimated)
Results: Posted 8 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 clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Sitagliptin 100 mg/100 mg	Active comparator	Drug: Sitagliptin (MK0431), Drug: Metformin - RescuePhase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
Sitagliptin 200 mg/200 mg	Active comparator	Drug: Sitagliptin, Drug: Metformin - RescuePhase A and B: Oral tablets of sitagliptin 200 mg q.d
Placebo/Sitagliptin 100 mg	Placebo comparator	Drug: Placebo, Drug: Metformin - RescuePhase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.
Placebo/Sitagliptin 200 mg	Placebo comparator	Drug: Placebo, Drug: Metformin - RescuePhase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with type 2 diabetes mellitus
Patient is not pregnant or breastfeeding
Male or female patient unlikely to conceive
Patient not on an antihyperglycemic drug

Key exclusion criteria (17 listed)

Patient has history of type 1 diabetes mellitus
Patient has history of ketoacidosis
Patient requires insulin within 8 weeks prior to start of study
Patient on weight loss program and is not in maintenance phase
Patient taking weight loss medication within 8 weeks prior to start of study

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 (MK0431)Also: MK0431, JanuviaPhase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.	Drug	Sitagliptin 100 mg/100 mg
SitagliptinAlso: MK0431, JanuviaPhase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.	Drug	Sitagliptin 200 mg/200 mg
PlaceboPhase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.	Drug	Placebo/Sitagliptin 100 mg
PlaceboPhase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.	Drug	Placebo/Sitagliptin 200 mg
Metformin - RescueAlso: Metformin, Glucophage, Glucophage XR, GlumetzaPhase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.	Drug	Placebo/Sitagliptin 100 mg, Placebo/Sitagliptin 200 mg, Sitagliptin 100 mg/100 mg, Sitagliptin 200 mg/200 mg

Primary outcome

Change From Baseline in A1C at Week 24
Time frame: Weeks 0-24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

5 secondary outcomes

Change From Baseline in FPG at Week 24
Time frame: Weeks 0-24
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
Time frame: Weeks 0-24
Change From Baseline in A1C at Week 104
Time frame: Weeks 0-104
Change From Baseline in FPG at Week 104
Time frame: Weeks 0-104
Change From Baseline in 2-hr PMG at Week 104
Time frame: Weeks 0-104

Results and safety

Results posted to the registry on 8 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 100 mg/100 mg	238	77
Sitagliptin 200 mg/200 mg	250	81
Placebo/Sitagliptin 100 mg	130	33
Placebo/Sitagliptin 200 mg	123	38

Primary outcome: Change From Baseline in A1C at Week 24

Time frame: Weeks 0-24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin 100 mg n = 229	Sitagliptin 200 mg n = 238	Placebo n = 244
Value	-0.61 (-0.74 to -0.49)	-0.76 (-0.88 to -0.64)	0.18 (0.06 to 0.30)

Sitagliptin 100 mg vs Placebo: Mean Difference (Net): -0.79 (95% CI -0.96 to -0.62), p <0.001, ANCOVA
Sitagliptin 200 mg vs Placebo: Mean Difference (Net): -0.94 (95% CI -1.11 to -0.77), p <0.001, ANCOVA

Population analysed: The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0-104. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 100 mg/100 mg	24 of 238 (10.1%)	127 of 238 (53.4%)	Not reported
Sitagliptin 200 mg/200 mg	25 of 250 (10%)	137 of 250 (54.8%)	Not reported
Placebo/Sitagliptin 100 mg	10 of 130 (7.7%)	70 of 130 (53.8%)	Not reported
Placebo/Sitagliptin 200 mg	13 of 123 (10.6%)	65 of 123 (52.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17130196Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.

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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 (MK0431), Sitagliptin and Metformin - Rescue in people with Diabetes Mellitus, Type 2, 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 17 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 3 Jul 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 8 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?

Change From Baseline in A1C at Week 24 (time frame: Weeks 0-24). 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 NCT00087516, 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 3 Jul 2015.