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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454233
• Other study ID #: 543-CL-003
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2007
• Last updated: October 14, 2008
• Start date: February 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• YM543
Oral
• Metformin
Oral
• Placebo
oral

Locations

Country	Name	City	State
Russian Federation	4 Sites	Moscow
Russian Federation	10 Sites	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)		3 Months	Yes
Secondary	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	No