Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

A Phase 1 study testing sitagliptin phosphate in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: sitagliptin phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: No sites listed yet
Study dates: 24 Aug 2007to 1 Jul 2008
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has Type 2 Diabetes
Patient is between the ages of 30-65 years
Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Who cannot join

Patient has Type 1 Diabetes
Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
Patient has taken insulin within the past 3 months

About this study

Official title: A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: sitagliptin phosphate, Comparator: Placebo
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
sitagliptin 100 mg tablets q.d. (once daily) for 7 days.
sitagliptin phosphateDrug
Also called MK0431
sitagliptin 200 mg tablets q.d. (once daily) for 7 days.
Comparator: PlaceboDrug
sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.

Study groups in NCT00541229
Study group	Role	What they receive
1	Experimental	sitagliptin 100 mg Receives: Drug: sitagliptin phosphate
2	Experimental	sitagliptin 200 mg Receives: Drug: sitagliptin phosphate
3	Placebo comparator	Placebo Receives: Drug: Comparator: Placebo

What is being measured

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

24-hour Weighted Mean Glucose (WMG)
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Measured: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.

Timeline

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

24 Aug 20071 Jul 2008

First posted10 Oct 2007 (estimated)
Study start24 Aug 2007
Primary completion17 Jun 2008
Study completion1 Jul 2008

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 DiabetesStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00541229
Sponsor's protocol ID: 0431-077
Other IDs: 2007_533
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

Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.
PubMed 19691426

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 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 Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise
ClinicalTrials.gov ID: NCT00541229
Acronym / sponsor ID: 0431-077
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Aug 2007 (actual)
Primary completion: 17 Jun 2008 (actual)
Study completion: 1 Jul 2008 (actual)
First posted: 10 Oct 2007 (estimated)
Results: Posted 28 Jul 2009

Clinical summary

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

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: sitagliptin phosphatesitagliptin 100 mg
2	Experimental	Drug: sitagliptin phosphatesitagliptin 200 mg
3	Placebo comparator	Drug: Comparator: PlaceboPlacebo

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has Type 2 Diabetes
Patient is between the ages of 30-65 years
Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Key exclusion criteria (3 listed)

Patient has Type 1 Diabetes
Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
Patient has taken insulin within the past 3 months

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: MK0431sitagliptin 100 mg tablets q.d. (once daily) for 7 days.	Drug	1
sitagliptin phosphateAlso: MK0431sitagliptin 200 mg tablets q.d. (once daily) for 7 days.	Drug	2
Comparator: Placebositagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.	Drug	3

Primary outcome

24-hour Weighted Mean Glucose (WMG)
Time frame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.

Results and safety

Results posted to the registry on 28 Jul 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
Placebo / 100 mg / 200 mg	17	17
100 mg / 200 mg / Placebo	16	15
200 mg / Placebo / 100 mg	20	17
Placebo / 200 mg / 100 mg	18	17
100 mg / Placebo / 200 mg	14	14
200 mg / 100 mg / Placebo	18	16

Primary outcome: 24-hour Weighted Mean Glucose (WMG)

Time frame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	Sitagliptin 200mg n = 28	Sitagliptin 100mg n = 26	Placebo n = 30
Value	169.1 (153.8 to 184.4)	159.0 (143.1 to 174.9)	200.9 (186.1 to 215.7)

Sitagliptin 200mg vs Placebo: Mean Difference (Final Values): -31.8 (95% CI -53.1 to -10.5), p = 0.004, ANOVA
Sitagliptin 100mg vs Placebo: Mean Difference (Final Values): -41.9 (95% CI -63.6 to -20.2), p <0.001, ANOVA
Sitagliptin 200mg vs Sitagliptin 100mg: Mean Difference (Final Values): 10.1 (80% CI 0.61 to 9999999)

Population analysed: The per-protocol (PP) population consisted of all patients randomized who had a measurement at Day 7 in Treatment Period I and did not have any major protocol violations. Missing data were not imputed.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 200 mg	0 of 78 (0%)	4 of 78 (5.1%)	Not reported
Sitagliptin 100 mg	0 of 72 (0%)	2 of 72 (2.8%)	Not reported
Placebo	0 of 74 (0%)	4 of 74 (5.4%)	Not reported

Limitations and caveats (from the sponsor): The pre-specified rule for non-superiority of sitagliptin 200 mg compared with 100 mg was met at the planned interim analysis. As such, the trial was terminated as pre-specified.

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 19691426Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.
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?

A Phase 1 study testing sitagliptin phosphate in people with Type 2 Diabetes, 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 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 28 Jul 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?

24-hour Weighted Mean Glucose (WMG) (time frame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.). 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 NCT00541229, 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.