MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)

MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371007

Enrollment

126

Registered

2006-09-01

Start date

2004-06-01

Completion date

2005-04-25

Last updated

2017-04-04

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

Conditions

Type 2 Diabetes Mellitus

Brief summary

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Interventions

DRUGMK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks

DRUGComparator : placebo (unspecified) / Duration of Treatment: 12 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Patients have type 2 diabetes mellitus * On diet/exercise therapy

Exclusion criteria

* Patients have type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
HbA1c, safety and tolerability	—

Secondary

Measure	Time frame
Plasma glucose	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026