Diabetes Mellitus, Type 2Phase 3NCT00086502

Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Comparator: Sitagliptin, Comparator: Pioglitazone and Metformin 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 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 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Comparator: Sitagliptin, Comparator: Pioglitazone and Metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 353 participants
Where: No sites listed yet
Study dates: Jun 2004to Nov 2005
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

Patient has type 2 diabetes mellitus (T2DM)
Patient is 18 years of age (or older)
Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period

Who cannot join

Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
Patient required insulin within the prior 8 weeks
Patient is on a weight loss program and is not in the maintenance phase
Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease

Show all 17Show fewer

Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
Patient has any of the following disorders within the past 6 months:
Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.
Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
Patient has severe peripheral vascular disease
Patient has congestive heart failure
Patient is HIV positive
Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
Patient has a history of neoplastic disease
Patient has a history of alcohol or drug abuse within the past 3 years
Patient has viral hepatitis (hepatitis B or C)

About this study

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

The purpose of this 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: Comparator: Sitagliptin, Comparator: Placebo, Comparator: Pioglitazone, 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.

Comparator: SitagliptinDrug
Also called Januvia
Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24
Comparator: PlaceboDrug
Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24
Comparator: PioglitazoneDrug
Also called ACTOS
Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
MetforminDrug
Metformin rescue for patients meeting
pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Study groups in NCT00086502
Study group	Role	What they receive
Sitagliptin 100 mg	Active comparator	Sitagliptin 100 mg Receives: Drug: Comparator: Sitagliptin; Drug: Comparator: Pioglitazone; Drug: Metformin
Placebo	Placebo comparator	Placebo Receives: Drug: Comparator: Placebo; Drug: Comparator: Pioglitazone; Drug: Metformin

What is being measured

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

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Measured: Baseline and week 24

Secondary outcomes (1)

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Measured: Baseline and week 24

Timeline

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

Jun 2004Nov 2005

First posted5 Jul 2004 (estimated)
Study startJun 2004
Primary completionNov 2005
Study completionNov 2005

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: 353 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00086502
Sponsor's protocol ID: 0431-019
Other IDs: Formally-A0604T2DPT, 2006_410
Status last verified: Feb 2016
First submitted: 2 Jul 2004
Last updated: 5 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Oct;28(10):1556-68. doi: 10.1016/j.clinthera.2006.10.007.
PubMed 17157112

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 5 Feb 2016. 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 the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy
ClinicalTrials.gov ID: NCT00086502
Acronym / sponsor ID: 0431-019
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 353 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Nov 2005 (actual)
Study completion: Nov 2005 (actual)
First posted: 5 Jul 2004 (estimated)
Results: Posted 19 Apr 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 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
Sitagliptin 100 mg	Active comparator	Drug: Comparator: Sitagliptin, Drug: Comparator: Pioglitazone, Drug: MetforminSitagliptin 100 mg
Placebo	Placebo comparator	Drug: Comparator: Placebo, Drug: Comparator: Pioglitazone, Drug: MetforminPlacebo

Who may qualify

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

Key inclusion criteria (3 listed)

Patient has type 2 diabetes mellitus (T2DM)
Patient is 18 years of age (or older)
Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period

Key exclusion criteria (17 listed)

Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
Patient required insulin within the prior 8 weeks
Patient is on a weight loss program and is not in the maintenance phase
Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)

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: SitagliptinAlso: JanuviaSitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24	Drug	Sitagliptin 100 mg
Comparator: PlaceboPlacebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24	Drug	Placebo
Comparator: PioglitazoneAlso: ACTOSPioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8	Drug	Placebo, Sitagliptin 100 mg
MetforminMetformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8	Drug	Placebo, Sitagliptin 100 mg

Primary outcome

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
Time frame: Baseline and week 24
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

1 secondary outcome

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Time frame: Baseline and week 24

Results and safety

Results posted to the registry on 19 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	175	149
Placebo	178	158

Primary outcome: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

Time frame: Baseline and week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin 100 mg n = 163	Placebo n = 174
Value	-0.85 (-0.98 to -0.72)	-0.15 (-0.28 to -0.03)

Sitagliptin 100 mg vs Placebo: Mean Difference (Net): -0.70 (95% CI -0.85 to -0.54), p <0.001, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Week 0 through Week 24.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 100 mg	5 of 175 (2.9%)	20 of 175 (11.4%)	Not reported
Placebo	8 of 178 (4.5%)	13 of 178 (7.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17157112Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Oct;28(10):1556-68. doi: 10.1016/j.clinthera.2006.10.007.

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
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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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
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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, Comparator: Pioglitazone and Metformin 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 3 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 5 Feb 2016. 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 19 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 HbA1c (Hemoglobin A1C) at Week 24 (time frame: Baseline and week 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 NCT00086502, 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 5 Feb 2016.