CClinicalTrials.gg
CompletedNCT00363844Updated Jun 14, 2012

Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

A Phase 3 interventional study of Sitagliptin phosphate in Type 2 Diabetes Mellitus, sponsored by Ono Pharmaceutical Co. Ltd. Completed at 8 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-06-14.

Sponsored by Ono Pharmaceutical Co. Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
209
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

Determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • MK-0431
  • ONO-5435
  • Type 2 diabetes mellitus
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 209 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Ono Pharmaceutical Co. Ltd is the lead sponsor of 66 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

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

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with type 2 diabetes mellitus on diet and exercise therapy

Exclusion criteria

Exclusion Criteria:

  • Patients with type 1 diabetes mellitus
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
209 participants (actual)

Study arms

  • Experimental
    E

    Drug: Sitagliptin phosphate

Interventions

  • DrugSitagliptin phosphate

    50 mg QD or 100 mg QD for 12 months

06

What researchers measure

Primary outcomes

  1. safety

    Time frame: 52 weeks

  2. tolerability

    Time frame: 52 weeks

Secondary outcomes

  1. HbA1c

    Time frame: 52 weeks

  2. Plasma glucose

    Time frame: 52 weeks

07

Study locations

8 sites
  • Chubu Region
    Chubu, Japan
  • Chugoku Region
    Chugoku, Japan
  • Hokkaido Region
    Hokkaido, Japan
  • Kanto Region
    Kanto, Japan
  • Kinki Region
    Kinki, Japan
  • Kyushu Region
    Kyushu, Japan
  • Shikoku Region
    Shikoku, Japan
  • Tohoku Region
    Tohoku, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00363844
Lead sponsor
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Aug 15, 2006
Start date
Aug 2006
Primary completion
Feb 2008
Last update
Jun 14, 2012

Study contacts

Mikio Nishii
study director · Ono Pharmaceutical Co. Ltd
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion