Type 2 Diabetes Mellitus (T2DM)Phase 1NCT00704132

Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

A Phase 1 study testing Comparator: sitagliptin phosphate in people with Type 2 Diabetes Mellitus (T2DM), 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

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control. Read more about this study

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: Comparator: sitagliptin phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: No sites listed yet
Study dates: 14 Feb 2007to 28 Apr 2010
Phase: Phase 1
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 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has type 2 diabetes mellitus
Males
Females who are highly unlikely to become pregnant
Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Who cannot join

Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
Participant required insulin therapy within the prior 8 weeks
Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

About this study

Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Conditions: Type 2 Diabetes Mellitus (T2DM)
Being tested: Comparator: sitagliptin phosphate, Comparator: placebo (unspecified)
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 phosphateDrug
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
Comparator: placebo (unspecified)Drug
Matching placebo tablet, administered once daily before the morning meal.

Study groups in NCT00704132
Study group	Role	What they receive
sitagliptin	Experimental	Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks. Receives: Drug: Comparator: sitagliptin phosphate
Placebo	Placebo comparator	Participants randomized to this arm will be administered matching placebo, daily for six weeks. Receives: Drug: Comparator: placebo (unspecified)

What is being measured

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

Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Measured: Baseline and Week 6

Timeline

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

14 Feb 200728 Apr 2010

First posted24 Jun 2008 (estimated)
Study start14 Feb 2007
Primary completion28 Apr 2010
Study completion28 Apr 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 Mellitus (T2DM)Studies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704132
Sponsor's protocol ID: 0431-059
Other IDs: 2006_511
Status last verified: Apr 2017
First submitted: 23 Jun 2008
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

Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.
PubMed 22685234

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 Type 2 Diabetes Mellitus (T2DM) trials

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 Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00704132
Acronym / sponsor ID: 0431-059
Conditions: Type 2 Diabetes Mellitus (T2DM)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 14 Feb 2007 (actual)
Primary completion: 28 Apr 2010 (actual)
Study completion: 28 Apr 2010 (actual)
First posted: 24 Jun 2008 (estimated)
Results: Posted 16 May 2011

Clinical summary

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

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
sitagliptin	Experimental	Drug: Comparator: sitagliptin phosphateParticipants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
Placebo	Placebo comparator	Drug: Comparator: placebo (unspecified)Participants randomized to this arm will be administered matching placebo, daily for six weeks.

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participant has type 2 diabetes mellitus
Males
Females who are highly unlikely to become pregnant
Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Key exclusion criteria (3 listed)

Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
Participant required insulin therapy within the prior 8 weeks
Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

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 phosphateSitagliptin tablet 100 mg, administered once daily before the morning meal.	Drug	sitagliptin
Comparator: placebo (unspecified)Matching placebo tablet, administered once daily before the morning meal.	Drug	Placebo

Primary outcome

Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
Time frame: Baseline and Week 6
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.

Results and safety

Results posted to the registry on 16 May 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
Sitagliptin	26	25
Placebo	24	22

Primary outcome: Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6

Time frame: Baseline and Week 6. Least squares mean (95% Confidence Interval). Unit: mg*hr/dL

Measure	Sitagliptin n = 25	Placebo n = 22
Value	-83.9 (87.7)	27.0 (84.3)

Sitagliptin vs Placebo: Difference in Least-Squares Mean: -111.0 (95% CI -158.0 to -63.9), p <0.001, ANCOVA

Population analysed: Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	1 of 26 (3.8%)	0 of 26 (0%)	Not reported
Placebo	0 of 24 (0%)	0 of 24 (0%)	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.
Derived from this study: PubMed 22685234Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.
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

Related trials for Type 2 Diabetes Mellitus (T2DM)

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 2
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Active, not recruiting
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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 1 study testing Comparator: sitagliptin phosphate in people with Type 2 Diabetes Mellitus (T2DM), 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 4 inclusion and 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 16 May 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 From Baseline in Glucose 5-Hour Incremental AUC at Week 6 (time frame: Baseline and Week 6). 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 NCT00704132, 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; AzTrials last refreshed its copy on 7 Nov 2026.