Diabetes Mellitus, Type 2Phase 3NCT00094757

An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

A Phase 3 study testing Comparator: sitagliptin 100 mg, Comparator: sitagliptin 200 mg and Comparator: pioglitazone 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

Search all trials

Trial summary

The purpose of this study is to determine the safety and effectiveness 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?: Comparator: sitagliptin 100 mg, Comparator: sitagliptin 200 mg and Comparator: pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 521 participants
Where: No sites listed yet
Study dates: 6 Oct 2004to 28 Apr 2006
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 at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Who cannot join

Younger than 18 years of age or older than 75
Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

About this study

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

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Conditions: Diabetes Mellitus, Type 2
Being tested: Comparator: sitagliptin 100 mg, Comparator: sitagliptin 200 mg, Comparator: placebo, Comparator: pioglitazone
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 100 mgDrug
sitagliptin 100 mg oral tablet once daily for 54 weeks
Comparator: sitagliptin 200 mgDrug
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
Comparator: placeboDrug
placebo oral tablet once daily during Phase A (Weeks 0-18)
Comparator: pioglitazoneDrug
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Study groups in NCT00094757
Study group	Role	What they receive
Sitagliptin 100 mg	Experimental	Sitagliptin 100 mg Receives: Drug: Comparator: sitagliptin 100 mg
Sitagliptin 200 mg	Experimental	Sitagliptin 200 mg Receives: Drug: Comparator: sitagliptin 200 mg
Placebo/Pioglitazone	Placebo comparator	Placebo/Pioglitazone Receives: Drug: Comparator: placebo; Drug: Comparator: pioglitazone

What is being measured

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

Change From Baseline in A1C at Week 18
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Measured: Weeks 0-18

Secondary outcomes (3)

Change From Baseline in FPG at Week 18
The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
Measured: Weeks 0-18
Change From Baseline in A1C at Week 54
A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Measured: Weeks 0-54
Change From Baseline in FPG at Week 54
The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.
Measured: Weeks 0-54

Timeline

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

6 Oct 200428 Apr 2006

First posted25 Oct 2004 (estimated)
Study start6 Oct 2004
Primary completion17 Aug 2005
Study completion28 Apr 2006

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: 521 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00094757
Sponsor's protocol ID: 0431-023
Other IDs: 2004_045
Status last verified: May 2019
First submitted: 22 Oct 2004
Last updated: 30 May 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.
PubMed 17001471

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 Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00094757
Acronym / sponsor ID: 0431-023
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 521 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Oct 2004 (actual)
Primary completion: 17 Aug 2005 (actual)
Study completion: 28 Apr 2006 (actual)
First posted: 25 Oct 2004 (estimated)
Results: Posted 21 Jul 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 determine the safety and effectiveness 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: 3

Arm	Type	Receives
Sitagliptin 100 mg	Experimental	Drug: Comparator: sitagliptin 100 mgSitagliptin 100 mg
Sitagliptin 200 mg	Experimental	Drug: Comparator: sitagliptin 200 mgSitagliptin 200 mg
Placebo/Pioglitazone	Placebo comparator	Drug: Comparator: placebo, Drug: Comparator: pioglitazonePlacebo/Pioglitazone

Who may qualify

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

Key inclusion criteria (1 listed)

Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Key exclusion criteria (2 listed)

Younger than 18 years of age or older than 75
Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

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 100 mgsitagliptin 100 mg oral tablet once daily for 54 weeks	Drug	Sitagliptin 100 mg
Comparator: sitagliptin 200 mgsitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks	Drug	Sitagliptin 200 mg
Comparator: placeboplacebo oral tablet once daily during Phase A (Weeks 0-18)	Drug	Placebo/Pioglitazone
Comparator: pioglitazonepioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)	Drug	Placebo/Pioglitazone

Primary outcome

Change From Baseline in A1C at Week 18
Time frame: Weeks 0-18
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

3 secondary outcomes

Change From Baseline in FPG at Week 18
Time frame: Weeks 0-18
Change From Baseline in A1C at Week 54
Time frame: Weeks 0-54
Change From Baseline in FPG at Week 54
Time frame: Weeks 0-54

Results and safety

Results posted to the registry on 21 Jul 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	205	152
Sitagliptin 200 mg	206	144
Placebo/Pioglitazone	110	80

Primary outcome: Change From Baseline in A1C at Week 18

Time frame: Weeks 0-18. Least squares mean (95% Confidence Interval). Unit: percent

Measure	Sitagliptin 100 mg n = 193	Sitagliptin 200 mg n = 199	Placebo/Pioglitazone n = 103
Value	-0.48 (-0.61 to -0.35)	-0.36 (-0.48 to -0.23)	0.12 (-0.05 to 0.30)

Sitagliptin 100 mg vs Placebo/Pioglitazone: Mean Difference (Net): -0.60 (95% CI -0.82 to -0.39), p <0.001, ANCOVA
Sitagliptin 200 mg vs Placebo/Pioglitazone: Mean Difference (Net): -0.48 (95% CI -0.70 to -0.26), p <0.001, ANCOVA

Population analysed: All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0 to 54. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 100 mg	15 of 205 (7.3%)	70 of 205 (34.1%)	Not reported
Sitagliptin 200 mg	12 of 206 (5.8%)	55 of 206 (26.7%)	Not reported
Placebo/Pioglitazone	10 of 110 (9.1%)	37 of 110 (33.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17001471Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Diabetes Mellitus, Type 2

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 Comparator: sitagliptin 100 mg, Comparator: sitagliptin 200 mg and Comparator: pioglitazone 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 1 inclusion and 2 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 30 May 2019. 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 21 Jul 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 18 (time frame: Weeks 0-18). 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 NCT00094757, 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 30 May 2019.