Type 2 Diabetes MellitusPhase 3NCT00289848

MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

A Phase 3 study testing 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.

Trial summary

This is a clinical study 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 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: sitagliptin phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 530 participants
Where: No sites listed yet
Study dates: Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Who cannot join

Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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

Conditions: Type 2 Diabetes Mellitus
Being tested: 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.

sitagliptin phosphateDrug
Also called Januvia
Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
Comparator: placeboDrug
placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

Study groups in NCT00289848
Study group	Role	What they receive
1	Experimental	sitagliptin 100 mg Receives: Drug: sitagliptin phosphate
2	Placebo comparator	placebo 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 (HbA1c) at Week 18
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and Week 18

Secondary outcomes (2)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Measured: Baseline and Week 18
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Measured: Baseline and Week 18

Timeline

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

Mar 2006Mar 2007

First posted10 Feb 2006 (estimated)
Study startMar 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 (2)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: 530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289848
Sponsor's protocol ID: 0431-040
Other IDs: MK0431-040, 2005_094
Status last verified: May 2015
First submitted: 7 Feb 2006
Last updated: 15 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20.
PubMed 19097665
Singh B, Sims H, Trueheart I, Simpson K, Wang KC, Patzkowsky K, Wegman T, Soma JM, Dixon R, Jayes F, Voegltine K, Yenokyan G, Su SC, Leppert P, Segars JH. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids. Reprod Sci. 2021 Sep;28(9):2699-2709. doi: 10.1007/s43032-021-00573-8. Epub 2021 Apr 29.
PubMed 33914296

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 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00289848
Acronym / sponsor ID: 0431-040
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 10 Feb 2006 (estimated)
Results: Posted 2 Apr 2010

Clinical summary

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

This is a clinical study 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: 2

Arm	Type	Receives
1	Experimental	Drug: sitagliptin phosphatesitagliptin 100 mg
2	Placebo comparator	Drug: Comparator: placeboplacebo

Who may qualify

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

Key inclusion criteria (1 listed)

Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Key exclusion criteria (1 listed)

Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

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 phosphateAlso: JanuviaSitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.	Drug	1
Comparator: placeboplacebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks	Drug	2

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
Time frame: Baseline and Week 18
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

2 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Time frame: Baseline and Week 18
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18
Time frame: Baseline and Week 18

Results and safety

Results posted to the registry on 2 Apr 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	352	306
Placebo	178	133

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18

Time frame: Baseline and Week 18. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin 100 mg n = 339	Placebo n = 169
Value	-0.71 (-0.84 to -0.59)	0.31 (0.14 to 0.48)

Sitagliptin 100 mg vs Placebo: Mean Difference (Net): -1.03 (95% CI -1.23 to -0.83), p <0.001, ANCOVA

Population analysed: The full-analysis-set (FAS) 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. Missing data were handled using the last observation carrying forward (LOCF) method.

2 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 100 mg	6 of 352 (1.7%)	0 of 352 (0%)	Not reported
Placebo	2 of 178 (1.1%)	0 of 178 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19097665Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20.
Derived from this study: PubMed 33914296Singh B, Sims H, Trueheart I, Simpson K, Wang KC, Patzkowsky K, Wegman T, Soma JM, Dixon R, Jayes F, Voegltine K, Yenokyan G, Su SC, Leppert P, Segars JH. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids. Reprod Sci. 2021 Sep;28(9):2699-2709. doi: 10.1007/s43032-021-00573-8. Epub 2021 Apr 29.

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.

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 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 1 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 15 Jun 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 2 Apr 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 Hemoglobin A1c (HbA1c) at Week 18 (time frame: Baseline and Week 18). 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 NCT00289848, which also lists 2 linked publications.

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 15 Jun 2015.