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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
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 29, 2007
Last Updated
October 14, 2008
Sponsor
Astellas Pharma Inc
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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

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

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