A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
Overview[ - collapse ][ - ]
| Purpose | 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 | Diabetes Mellitus Type 2 |
| Intervention | Drug: YM543 Drug: Metformin Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | Astellas Pharma Inc |
| Responsible Party | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier | NCT00454233 |
| First Received | March 29, 2007 |
| Last Updated | October 14, 2008 |
| Last verified | October 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 29, 2007 |
|---|---|
| Last Updated Date | October 14, 2008 |
| Start Date | February 2007 |
| Estimated Primary Completion Date | June 2008 |
| Current 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] [Designated as safety issue: Yes] |
| Current 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] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| 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 |
| 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus Type 2 |
| Intervention | Drug: YM543 Oral Drug: Metformin Oral Drug: Placebo oral |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 97 |
| Estimated Completion Date | June 2008 |
| Estimated Primary Completion Date | June 2008 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Russian Federation |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00454233 |
|---|---|
| Other Study ID Numbers | 543-CL-003 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Astellas Pharma Inc |
| Study Sponsor | Astellas Pharma Inc |
| Collaborators | Not Provided |
| Investigators | Study Chair: Use Central Contact Astellas Pharma Europe B.V. |
| Verification Date | October 2008 |
Locations[ + expand ][ + ]
| Russian Federation | Ekaterinburg, Russian Federation |
|---|---|
| 4 Sites | Moscow, Russian Federation |
| Russian Federation | N. Novgorod, Russian Federation |
| Russian Federation | Petrozavodsk, Russian Federation |
| Russian Federation | Samara, Russian Federation |
| 10 Sites | St. Petersburg, Russian Federation |