CompletedNCT00875394Updated May 30, 2017Results posted

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

A Phase 3 interventional study of sitagliptin phosphate and Comparator: metformin in Diabetes Mellitus, Non-Insulin-Dependent, 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 3, Interventional, and Treatment

From the registry’s dates

Registered 2 years 2 months after the study started (first participant enrolled Feb 2007, registered Apr 2009).

Phase: Phase 3
Study type: Interventional
Enrollment: 68
Allocation: Randomized
Ages: 30 Years to 78 Years
Sex: All

Study summary

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Conditions studied

Diabetes Mellitus, Non-Insulin-Dependent

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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 68 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

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

Inclusion criteria

Patient Has Type 2 Diabetes Mellitus
Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
Patient Is Currently On Metformin Therapy (1500 Mg/Day)
Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
Patient Has An A1c of 6.5 % - 11.0%

Exclusion criteria

Exclusion Criteria:

Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 68 participants (actual)

Study arms

Experimental
1
sitagliptin + metformin
Drug: sitagliptin phosphate · Drug: Comparator: metformin
Active comparator
2
metformin + any other oral antidiabetic drug
Drug: Comparator: metformin · Drug: Comparator: Antidiabetic Standard of Care
Active comparator
3
metformin
Drug: Comparator: metformin

Interventions

Drugsitagliptin phosphate
sitagliptin 100 mg Once a day (QD) for 24 weeks
Also known as: sitagliptin
DrugComparator: metformin
metformin 850 mg Twice a day (BID) for 24 weeks
Also known as: metformin
DrugComparator: metformin
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Also known as: metformin
DrugComparator: Antidiabetic Standard of Care
Patient can take any oral antidiabetic drug (other than metformin)

What researchers measure

Primary outcomes

Change From Baseline in Glycosylated Hemoglobin A1C (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 Apr 20, 2011

Limitations and caveats

A limited number of participants were recruited into this open-label study. This study was conducted at a single site. Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Participant flow

Patients were recruited in Principal Investigator's private practice, in Mexico City. First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008

Participant flow — Overall Study
Milestone	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone
Started	36	23	9
Completed	36	23	9
Not completed	0	0	0

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin A1C (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

No measurements were reported for this outcome.

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Sitagliptin + Metformin	—	0/36 (0%)	0/36 (0%)
Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	—	0/23 (0%)	1/23 (4.3%)
Metformin Alone	—	0/9 (0%)	0/9 (0%)

Most frequent other events

Most frequent other events
Event	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone
NauseaGastrointestinal disorders	0/36	1/23	0/9
CoughRespiratory, thoracic and mediastinal disorders	0/36	1/23	0/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone	Total
Mean	54.2 ± 9.8	56.0 ± 8.5	53.3 ± 11.7	54.69 ± 9.55

Sex: Female, Male
Sex: Female, Male(Participants)	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone	Total
Female	25	19	6	50
Male	11	4	3	18

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone	Total
Mean	29.0 ± 4.5	28.8 ± 5.1	28.3 ± 5.2	28.84 ± 4.74

Glycosylated Hemoglobin A1C (A1C)
Glycosylated Hemoglobin A1C (A1C)(Percent)	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone	Total
Mean	8.8 ± 1.5	8.0 ± 1.8	8.2 ± 1.1	8.47 ± 1.61

Time since diagnosis of diabetes
Time since diagnosis of diabetes(Years)	Sitagliptin + Metformin	Metformin + Any Non-DPP-4i Oral Antidiabetic Drug	Metformin Alone	Total
Mean	8.9 ± 7.1	6.8 ± 8.5	10.9 ± 7.7	8.43 ± 7.68

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: NCT00875394
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Apr 3, 2009
Start date: Feb 1, 2007
Primary completion: Jun 27, 2008
Completion: Jun 27, 2008
Results posted: Apr 20, 2011
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 ↗

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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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