Type 2 Diabetes MellitusPhase 3NCT00541450

A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)

A Phase 3 study testing Comparator: sitagliptin phosphate (sitagliptin), sitagliptin phosphate (+) metformin hydrochloride and Comparator: pioglitazone 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 evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes. 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 (sitagliptin), sitagliptin phosphate (+) metformin hydrochloride 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: 492 participants
Where: No sites listed yet
Study dates: 15 Jan 2008to 16 Jan 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

Patients between the ages of 18 and 78 with type 2 diabetes mellitus
Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months

Who cannot join

Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor

About this study

Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.

Conditions: Type 2 Diabetes Mellitus
Being tested: Comparator: sitagliptin phosphate (sitagliptin), sitagliptin phosphate (+) metformin hydrochloride, Comparator: pioglitazone, Matching placebo to pioglitazone, Matching placebo to sitagliptin
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 phosphate (sitagliptin)Drug
Also called MK0431, Januvia™
sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period
sitagliptin phosphate (+) metformin hydrochlorideDrug
Also called MK-0431A, Janumet™
sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period
Comparator: pioglitazoneDrug
Also called Actos®
pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.
Matching placebo to pioglitazoneDrug
matching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period.
Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks.
Matching placebo to sitagliptinDrug
matching placebo to sitagliptin q.d., orally for a 12-wk treatment period.
Matching Placebo to Sita/Met FDCDrug
matching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).

Study groups in NCT00541450
Study group	Role	What they receive
Sita/Met FDC	Experimental	In Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks. In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone. Receives: Drug: Comparator: sitagliptin phosphate (sitagliptin); Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: Matching placebo to pioglitazone
Pioglitazone	Active comparator	In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d. In Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks). Receives: Drug: Comparator: pioglitazone; Drug: Matching placebo to sitagliptin; Drug: Matching Placebo to Sita/Met FDC

What is being measured

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

Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks
The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.
Measured: Baseline to 40 weeks
Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.
Measured: Baseline to 12 weeks

Secondary outcomes (4)

Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.
Measured: Baseline and 40 weeks
Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
Measured: Baseline to 12 weeks
Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.
Measured: Baseline and 40 weeks
Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.
Measured: Baseline to 12 weeks

Timeline

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

15 Jan 200816 Jan 2010

First posted10 Oct 2007 (estimated)
Study start15 Jan 2008
Primary completion8 Jan 2010
Study completion16 Jan 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: 492 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00541450
Sponsor's protocol ID: 0431-068
Other IDs: 2007_501
Status last verified: Apr 2017
First submitted: 5 Oct 2007
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
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

Perez-Monteverde A, Seck T, Xu L, Lee MA, Sisk CM, Williams-Herman DE, Engel SS, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.x.
PubMed 21849007

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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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 Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00541450
Acronym / sponsor ID: 0431-068
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 492 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 15 Jan 2008 (actual)
Primary completion: 8 Jan 2010 (actual)
Study completion: 16 Jan 2010 (actual)
First posted: 10 Oct 2007 (estimated)
Results: Posted 14 Apr 2011

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 evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication 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: 2

Arm	Type	Receives
Sita/Met FDC	Experimental	Drug: Comparator: sitagliptin phosphate (sitagliptin), Drug: sitagliptin phosphate (+) metformin hydrochloride, Drug: Matching placebo to pioglitazoneIn Phase A (Treatment Day 1 to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to 15 mg pioglitazone q.d. for 6 weeks followed by matching placebo to 30 mg pioglitazone for the next 6 weeks. In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks; as well as matching placebo to 45 mg pioglitazone.
Pioglitazone	Active comparator	Drug: Comparator: pioglitazone, Drug: Matching placebo to sitagliptin, Drug: Matching Placebo to Sita/Met FDCIn Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone and matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg pioglitazone q.d. In Phase B (Treatment Week 12 to Week 40), participants were administered 45 mg pioglitazone q.d.; as well as matching placebo to Sita/Met FDC (50/500 increased to 50/1000 b.i.d. after 4 weeks).

Who may qualify

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

Key inclusion criteria (2 listed)

Patients between the ages of 18 and 78 with type 2 diabetes mellitus
Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months

Key exclusion criteria (2 listed)

Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor

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 phosphate (sitagliptin)Also: MK0431, Januvia™sitagliptin 100 mg tablet q.d. orally for a 12-wk treatment period	Drug	Sita/Met FDC
sitagliptin phosphate (+) metformin hydrochlorideAlso: MK-0431A, Janumet™sitagliptin/metformin HCl (Sita/Met) 50/500 mg b.i.d. orally and then 50/1000 mg b.i.d. orally for a 28-wk treatment period	Drug	Sita/Met FDC
Comparator: pioglitazoneAlso: Actos®pioglitazone 15 mg tablet q.d. orally for 6 weeks, followed by 30 mg q.d orally for 6 weeks, followed by 45 mg q.d. orally, up to 40 weeks.	Drug	Pioglitazone
Matching placebo to pioglitazonematching placebo to pioglitazone tablet q.d. orally, for a 40-wk treatment period. Participants were administered matching placebo the 15 mg pioglitazone q.d. orally for 6 weeks, followed by matching placebo to 30 mg pioglitazone q.d orally for 6 weeks, followed by matching placebo to 45 mg pioglitazone q.d. orally, up to 40 weeks.	Drug	Sita/Met FDC
Matching placebo to sitagliptinmatching placebo to sitagliptin q.d., orally for a 12-wk treatment period.	Drug	Pioglitazone
Matching Placebo to Sita/Met FDCmatching placebo to Sita/Met FDC - 50/500 mg b.i.d. for 4 weeks and then 50/1000 mg b.i.d. orally for a 28-wk treatment period (Week 12 to Week 40).	Drug	Pioglitazone

Primary outcome

Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks
Time frame: Baseline to 40 weeks
The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.
Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
Time frame: Baseline to 12 weeks
The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.

4 secondary outcomes

Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
Time frame: Baseline and 40 weeks
Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
Time frame: Baseline to 12 weeks
Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
Time frame: Baseline and 40 weeks
Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
Time frame: Baseline to 12 weeks

Results and safety

Results posted to the registry on 14 Apr 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
Sita/Met FDC	244	224
Pioglitazone	248	231

Primary outcome: Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks

Time frame: Baseline to 40 weeks. Least squares mean (95% Confidence Interval). Unit: percentage of glycosylated hemoglobin

Measure	Sita/Met FDC n = 218	Pioglitazone n = 222
Value	-1.75 (-1.92 to -1.59)	-1.38 (-1.55 to -1.21)

Sita/Met FDC vs Pioglitazone: p = 0.002, ANCOVA

Population analysed: All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and (2) had a baseline measurement and at least one on-treatment measurement for A1C.

Primary outcome: Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

Time frame: Baseline to 12 weeks. Least squares mean (95% Confidence Interval). Unit: percentage of glycosylated hemoglobin

Measure	Sitagliptin (Phase A) n = 231	Pioglitazone (Phase A) n = 240
Value	-1.03 (-1.18 to -0.88)	-0.87 (-1.02 to -0.72)

Sitagliptin (Phase A) vs Pioglitazone (Phase A): Difference in LS Means: -0.16 (95% CI -0.37 to 0.05), ANCOVA

Population analysed: All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for A1C.

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 (Weeks 0-12)	3 of 244 (1.2%)	7 of 244 (2.9%)	Not reported
Pioglitazone (Weeks 0-12)	1 of 248 (0.4%)	15 of 248 (6%)	Not reported
Sita/Met FDC (Weeks 0-40)	8 of 222 (3.6%)	20 of 222 (9%)	Not reported
Pioglitazone (Weeks 0-40)	3 of 230 (1.3%)	33 of 230 (14.3%)	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.
Results publication: PubMed 21849007Perez-Monteverde A, Seck T, Xu L, Lee MA, Sisk CM, Williams-Herman DE, Engel SS, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.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

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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?

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 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 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. 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 14 Apr 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 in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks (time frame: Baseline to 40 weeks). The study lists 2 primary outcomes in all. 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 NCT00541450, 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.