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
2 other identifiers
interventional
97
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Feb 2007
Typical duration for phase_2 diabetes-mellitus-type-2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 29, 2007
CompletedFirst Posted
Study publicly available on registry
March 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedOctober 16, 2008
October 1, 2008
1.3 years
March 29, 2007
October 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)
3 Months
Secondary Outcomes (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)
3 Months
Study Arms (6)
1
EXPERIMENTALDose 1
2
EXPERIMENTALDose 2
3
EXPERIMENTALDose 3
4
EXPERIMENTALDose 4
5
ACTIVE COMPARATOR6
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
4 Sites
Moscow, Russia
Unknown Facility
Nizhny Novgorod, Russia
Unknown Facility
Petrozavodsk, Russia
10 Sites
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Yekaterinburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 29, 2007
First Posted
March 30, 2007
Study Start
February 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
October 16, 2008
Record last verified: 2008-10