Diabetes Mellitus, Type 2Phase 3NCT00106704

Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

A Phase 3 study testing Comparator: Sitagliptin 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

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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?: Comparator: Sitagliptin 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: 441 participants
Where: No sites listed yet
Study dates: Mar 2005to Jan 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 with inadequate glycemic control

Who cannot join

Patients with Type 1 Diabetes Mellitus

About this study

Official title: A Multicenter, Randomized, Double Blind, Placebo-Controlled 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 Glimepiride Alone or in Combination With Metformin

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: Comparator: Sitagliptin, 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: SitagliptinDrug
sitagliptin 10 mg tablet, once daily for 54 weeks
Comparator: PlaceboDrug
Placebo oral tablet once daily for 24 weeks
Comparator: PioglitazoneDrug
Pioglitazone 30 mg tablet once daily for 30 weeks

Study groups in NCT00106704
Study group	Role	What they receive
Sitagliptin	Experimental	Sitagliptin 10 mg tablet daily for 54 weeks Receives: Drug: Comparator: Sitagliptin
Placebo/ Pioglitazone	Placebo comparator	Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks 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 24
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Measured: Baseline and 24 Weeks

Secondary outcomes (1)

Change From Baseline in FPG at Week 24
The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
Measured: Baseline and 24 Weeks

Timeline

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

Mar 2005Jan 2007

First posted30 Mar 2005 (estimated)
Study startMar 2005
Primary completionJun 2006
Study completionJan 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 441 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106704
Sponsor's protocol ID: 0431-035
Other IDs: 2005_009
Status last verified: Jun 2015
First submitted: 29 Mar 2005
Last updated: 1 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.
PubMed 17593236

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 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double Blind, Placebo-Controlled 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 Glimepiride Alone or in Combination With Metformin
ClinicalTrials.gov ID: NCT00106704
Acronym / sponsor ID: 0431-035
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 441 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Jun 2006 (actual)
Study completion: Jan 2007 (actual)
First posted: 30 Mar 2005 (estimated)
Results: Posted 17 Dec 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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: Comparator: SitagliptinSitagliptin 10 mg tablet daily for 54 weeks
Placebo/ Pioglitazone	Placebo comparator	Drug: Comparator: Placebo, Drug: Comparator: PioglitazonePlacebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks

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 with Type 2 Diabetes Mellitus with inadequate glycemic control

Key exclusion criteria (1 listed)

Patients with Type 1 Diabetes Mellitus

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: Sitagliptinsitagliptin 10 mg tablet, once daily for 54 weeks	Drug	Sitagliptin
Comparator: PlaceboPlacebo oral tablet once daily for 24 weeks	Drug	Placebo/ Pioglitazone
Comparator: PioglitazonePioglitazone 30 mg tablet once daily for 30 weeks	Drug	Placebo/ Pioglitazone

Primary outcome

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

1 secondary outcome

Change From Baseline in FPG at Week 24
Time frame: Baseline and 24 Weeks

Results and safety

Results posted to the registry on 17 Dec 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	222	91
Placebo/ Pioglitazone	219	68

Primary outcome: Change From Baseline in A1C at Week 24

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

Measure	Sitagliptin n = 217	Placebo/ Pioglitazone n = 208
Value	-0.45 (-0.57 to -0.34)	0.28 (0.17 to 0.40)

Sitagliptin vs Placebo/ Pioglitazone: Mean Difference (Net): -0.74 (95% CI -90.0 to -0.57), p <0.001, ANCOVA

Population analysed: All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.

1 secondary outcome is 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	17 of 222 (7.7%)	66 of 222 (29.7%)	Not reported
Placebo/ Pioglitazone	13 of 219 (5.9%)	57 of 219 (26%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17593236Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.

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Active, not recruiting
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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
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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 Comparator: Sitagliptin 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 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 1 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 17 Dec 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: Baseline and 24 Weeks). 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 NCT00106704, 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 1 Jul 2015.