CompletedNCT00832390Updated May 30, 2017Results posted

Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)

A Phase 4 interventional study of sitagliptin phosphate in Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 30 Years to 78 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment

From the registry’s dates

Registered 1 year 11 months after the study started (first participant enrolled Feb 2007, registered Jan 2009).

Phase: Phase 4
Study type: Interventional
Enrollment: 29
Allocation: Randomized
Ages: 30 Years to 78 Years
Sex: All

Study summary

After 24 weeks of treatment evaluate the efficacy and security.

Conditions studied

Diabetes Mellitus

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 78 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Patients Being Treated With Metformin
Patients With Hba1c Between 6.5 % And 12.0%.
Type 2 DM

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Experimental
1
sitagliptin
Drug: sitagliptin phosphate

Interventions

Drugsitagliptin phosphate
Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets
Also known as: MK0431

What researchers measure

Primary outcomes

Change From Baseline in A1C at Week 24
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Time frame: Baseline and 24 Weeks

Results

Posted Jul 31, 2009

Limitations and caveats

Few participants were recruited into this single-site study as the investigator preferred the use of initial combination therapy. Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Participant flow

Single site study with patients recruited in Principal Investigator's private practice, Mexico City. First Patient In: 14Feb2007. Last Patient's Last Visit: 11Jul2008

Participant flow — Overall Study
Milestone	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen
Started	12	16	1
Completed	12	16	1
Not completed	0	0	0

Outcome measures

PrimaryChange From Baseline in A1C at Week 24

Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

Time frame:: Baseline and 24 Weeks
Reported as:: Mean · Percent Difference

Change From Baseline in A1C at Week 24
Percent Difference	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen
Change From Baseline in A1C at Week 24	-0.2 (-0.9 to 0.5)	-1.0 (-2.1 to -0.1)	0.0 (0.0 to 0.0)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sitagliptin 100 mg q.d. (Once Daily)	—	0/12 (0%)	1/12 (8.3%)
Sitagliptin 100 mg q.d. (Once Daily) and Metformin	—	0/16 (0%)	0/16 (0%)
Standard Care Regimen	—	0/1 (0%)	0/1 (0%)

Most frequent other events

Most frequent other events
Event	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen
HypertensionVascular disorders	1/12	0/16	0/1

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen	Total
Mean	57.6 ± 14.1	52.5 ± 9.3	51.0 ± 0.0	54.62 ± 11.43

Sex: Female, Male
Sex: Female, Male(Participants)	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen	Total
Female	6	13	1	20
Male	6	3	0	9

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen	Total
Mean	27.4 ± 10.0	28.9 ± 5.2	26.0 ± 0.0	28.14 ± 7.41

Glycosylated Hemoglobin A1C (A1C)
Glycosylated Hemoglobin A1C (A1C)(Percent)	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen	Total
Mean	7.1 ± 0.6	8.6 ± 1.4	6.9 ± 0.0	7.96 ± 1.33

Time Since Diagnosis of Diabetes
Time Since Diagnosis of Diabetes(Years)	Sitagliptin 100 mg q.d. (Once Daily)	Sitagliptin 100 mg q.d. (Once Daily) and Metformin	Standard Care Regimen	Total
Mean	5.3 ± 7.0	6.2 ± 6.0	5.2 ± 0.0	5.82 ± 6.25

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00832390
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Jan 30, 2009
Start date: Feb 14, 2007
Primary completion: Jul 11, 2008
Completion: Jul 11, 2008
Results posted: Jul 31, 2009
Last update: May 30, 2017

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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