A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
YM543
Metformin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Diabetes Mellitus Type 2, YM543, Treatment, Safety, efficacy
Eligibility Criteria
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
Sites / Locations
- 4 Sites
- 10 Sites
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
5
6
Arm Description
Dose 1
Dose 2
Dose 3
Dose 4
Outcomes
Primary Outcome Measures
Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00454233
Brief Title
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Diabetes Mellitus Type 2, YM543, Treatment, Safety, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
2
Arm Type
Experimental
Arm Description
Dose 2
Arm Title
3
Arm Type
Experimental
Arm Description
Dose 3
Arm Title
4
Arm Type
Experimental
Arm Description
Dose 4
Arm Title
5
Arm Type
Active Comparator
Arm Title
6
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YM543
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
City
Ekaterinburg
Country
Russian Federation
Facility Name
4 Sites
City
Moscow
Country
Russian Federation
City
N. Novgorod
Country
Russian Federation
City
Petrozavodsk
Country
Russian Federation
City
Samara
Country
Russian Federation
Facility Name
10 Sites
City
St. Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
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