A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects

A Randomized, Double Blind, Placebo and Active Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Potential Efficacy of a 12-Week Treatment With YM543 in Subjects With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00454233

Enrollment

Registered

2007-03-30

Start date

2007-02-28

Completion date

2008-06-30

Last updated

2008-10-16

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

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2, YM543, Treatment, Safety, efficacy

Brief summary

The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients

Interventions

DRUGYM543

Oral

DRUGMetformin

Oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Treatment-naive subjects diagnosed with T2DM * Stable diet and exercise program for at least 6 weeks * Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1

Exclusion criteria

* Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders * Use of insulin or oral blood glucose lowering drugs in the last 3 months

Design outcomes

Primary

Measure	Time frame
Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)	3 Months

Secondary

Measure	Time frame
Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel)	3 Months

Countries

Russia

Outcome results

None listed

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