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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: March 29, 2007
Last updated: October 14, 2008
Last verified: October 2008
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

Condition Intervention Phase
Diabetes Mellitus Type 2 Drug: YM543 Drug: Metformin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination) [ Time Frame: 3 Months ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 3 Months ]

Enrollment: 97
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose 1
Drug: YM543
Experimental: 2
Dose 2
Drug: YM543
Experimental: 3
Dose 3
Drug: YM543
Experimental: 4
Dose 4
Drug: YM543
Active Comparator: 5 Drug: Metformin
Placebo Comparator: 6 Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00454233

Russian Federation
Ekaterinburg, Russian Federation
4 Sites
Moscow, Russian Federation
N. Novgorod, Russian Federation
Petrozavodsk, Russian Federation
Samara, Russian Federation
10 Sites
St. Petersburg, Russian Federation
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT00454233     History of Changes
Other Study ID Numbers: 543-CL-003
EudraCT number: 2006-001110-33
Study First Received: March 29, 2007
Last Updated: October 14, 2008

Keywords provided by Astellas Pharma Inc:
Diabetes Mellitus Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 20, 2017