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

A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482079

Enrollment

743

Registered

2007-06-04

Start date

2003-05-13

Completion date

2006-06-15

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

Brief summary

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

Interventions

DRUGMK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks

DRUGComparator: placebo (unspecified) / Duration of Treatment: 21 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To asses the effectiveness of MK0431 compared to placebo	over 12 weeks

Secondary

Measure	Time frame
To test the safety and tolerability of MK0431 in patients with type 2 diabetes	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026