CClinicalTrials.gg
CompletedNCT00482079Updated Mar 28, 2017

A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

A Phase 2 interventional study of MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks and Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks in Diabetes Mellitus, Type II, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled May 2003, registered Jun 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
743
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

02

Conditions studied

  • Diabetes Mellitus, Type II
03

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 743 is above 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.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 21 to 70, You are a man or non-pregnant woman

Exclusion criteria

Exclusion Criteria:

  • Have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medications
  • You have a history of minor surgery
  • You have received investigational drugs within 8 weeks of study start
  • You have hepatitis B or C
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
743 participants (actual)

Interventions

  • DrugMK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
  • DrugComparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
06

What researchers measure

Primary outcomes

  1. To asses the effectiveness of MK0431 compared to placebo

    Time frame: over 12 weeks

Secondary outcomes

  1. To test the safety and tolerability of MK0431 in patients with type 2 diabetes

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. doi: 10.1111/j.1742-1241.2006.01246.x. Epub 2006 Dec 5. PubMed 17156104 ↗
  • Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30. Erratum In: Diabetes Ther. 2015 Mar;6(1):97-8. doi: 10.1007/s13300-015-0101-7. PubMed 25633134 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00482079
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 4, 2007
Start date
May 13, 2003
Primary completion
Aug 25, 2004
Completion
Jun 15, 2006
Last update
Mar 28, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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