Diabetes Mellitus, Non-Insulin-DependentPhase 2NCT00758069

Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

A Phase 2 study testing sitagliptin phosphate and Comparator: Sitagliptin in people with Diabetes Mellitus, Non-Insulin-Dependent, 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 determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy Read more about this study

Who is it for?: Ages 20 to 69 years
Conditions the study is for: Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?: sitagliptin phosphate and Comparator: Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: 3 Jul 2005to 13 Feb 2006
Phase: Phase 2
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 20 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Who cannot join

Patients Have Type 1 Diabetes Mellitus

About this study

Official title: Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Being tested: sitagliptin phosphate, Comparator: Placebo, Comparator: 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.

sitagliptin phosphateDrug
Also called MK0431
100 mg once daily (QD), taken orally for 4 weeks
Comparator: PlaceboDrug
Placebo tablet, QD, taken orally for 4 weeks
Comparator: SitagliptinDrug
Also called MK0431
50 mg twice daily (BID), taken orally for 4 weeks

Study groups in NCT00758069
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Comparator: Placebo
2	Experimental	Sitagliptin 100 mg Receives: Drug: sitagliptin phosphate
3	Experimental	Sitagliptin 50 mg Receives: Drug: Comparator: Sitagliptin

What is being measured

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

Change From Baseline in 24-hour Weighted Mean Plasma Glucose
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
Measured: Baseline and Week 4

Secondary outcomes (1)

Change From Baseline in Plasma Glucose
Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.
Measured: Baseline and Week 4

Timeline

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

3 Jul 200513 Feb 2006

First posted23 Sep 2008 (estimated)
Study start3 Jul 2005
Primary completion13 Feb 2006
Study completion13 Feb 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, Non-Insulin-DependentStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758069
Sponsor's protocol ID: 0431-045
Other IDs: MK0431-045, 2008_026
Status last verified: Mar 2017
First submitted: 22 Sep 2008
Last updated: 5 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.
PubMed 19253204

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, Non-Insulin-Dependent trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects
ClinicalTrials.gov ID: NCT00758069
Acronym / sponsor ID: 0431-045
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 3 Jul 2005 (actual)
Primary completion: 13 Feb 2006 (actual)
Study completion: 13 Feb 2006 (actual)
First posted: 23 Sep 2008 (estimated)
Results: Posted 25 Sep 2009

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 determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Placebo comparator	Drug: Comparator: PlaceboPlacebo
2	Experimental	Drug: sitagliptin phosphateSitagliptin 100 mg
3	Experimental	Drug: Comparator: SitagliptinSitagliptin 50 mg

Who may qualify

Ages: 20 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Key exclusion criteria (1 listed)

Patients Have 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
sitagliptin phosphateAlso: MK0431100 mg once daily (QD), taken orally for 4 weeks	Drug	2
Comparator: PlaceboPlacebo tablet, QD, taken orally for 4 weeks	Drug	1
Comparator: SitagliptinAlso: MK043150 mg twice daily (BID), taken orally for 4 weeks	Drug	3

Primary outcome

Change From Baseline in 24-hour Weighted Mean Plasma Glucose
Time frame: Baseline and Week 4
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.

1 secondary outcome

Change From Baseline in Plasma Glucose
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 25 Sep 2009, 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 QD	27	26
Sitagliptin 50 mg BID	25	25
Placebo	28	27

Primary outcome: Change From Baseline in 24-hour Weighted Mean Plasma Glucose

Time frame: Baseline and Week 4. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	Sitagliptin 100 mg QD n = 25	Sitagliptin 50 mg BID n = 24	Placebo n = 27
Value	-34.9 (-40.9 to 28.9)	-28.6 (-34.7 to 22.4)	-9.0 (-14.8 to -3.2)

Sitagliptin 100 mg QD vs Placebo: Least-squares Mean Difference: -25.9 (95% CI -34.2 to -17.5), p <0.001, ANCOVA
Sitagliptin 50 mg BID vs Placebo: Least-squares Mean Difference: -19.5 (95% CI -28.0 to -11.1), p <0.001, ANCOVA

Population analysed: The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.

1 secondary outcome is 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 100 mg QD	1 of ?	1 of ?	Not reported
Sitagliptin 50 mg BID	2 of ?	1 of ?	Not reported
Placebo	0 of ?	2 of ?	Not reported

Limitations and caveats (from the sponsor): Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19253204Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.

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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 2 study testing sitagliptin phosphate and Comparator: Sitagliptin in people with Diabetes Mellitus, Non-Insulin-Dependent, 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Sep 2009). 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 24-hour Weighted Mean Plasma Glucose (time frame: Baseline and Week 4). 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 NCT00758069, 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 May 2017.