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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454233
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : October 16, 2008
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: YM543 Drug: Metformin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454233

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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
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Study Chair: Use Central Contact Astellas Pharma Europe B.V.

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Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT00454233    
Other Study ID Numbers: 543-CL-003
EudraCT number: 2006-001110-33
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008
Keywords provided by Astellas Pharma Inc:
Diabetes Mellitus Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs