Drug to Drug Interaction Study With ASP1941 and Metformin
Overview[ - collapse ][ - ]
Purpose | A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: ASP1941 Drug: Metformin Drug: Placebo |
Phase | Phase 1 |
Sponsor | Astellas Pharma Inc |
Responsible Party | Astellas Pharma Inc |
ClinicalTrials.gov Identifier | NCT01302145 |
First Received | February 21, 2011 |
Last Updated | February 21, 2011 |
Last verified | February 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | February 21, 2011 |
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Last Updated Date | February 21, 2011 |
Start Date | February 2009 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures | Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring [Time Frame: 5 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Drug to Drug Interaction Study With ASP1941 and Metformin |
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Official Title | A Double-blind, Randomized, Placebo-controlled, Parallel Design Study, in Patients With Type 2 Diabetes Mellitus, to Investigate the Safety, Pharmacokinetics and Pharmacodynamics Interactions of Multiple Oral Doses of ASP1941 and Metformin |
Brief Summary | A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: ASP1941 Tablet Drug: Metformin Tablet Drug: Placebo Tablet |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 36 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 2009 |
Eligibility Criteria | Inclusion Criteria: - Subjects with type 2 diabetes - Stable disease under metformin monotherapy (between 1500-3000 mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months - Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out) - Stable Fasting Blood Glucose (FBG) at the end of wash-out - BMI between 18.5 and 40.0 kg/m2, inclusive Exclusion Criteria: - Subjects with type 1 diabetes - Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy - Clinical significant renal disease (CLcr <60 ml/min as assessed during a 24h creatinine clearance on Day-2 - Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose <3 mmol/l (<55 mg/dl) or requiring hospitalization - Pulse <40 or >90; Systolic Blood Pressure >160 mmHg; Diastolic Blood Pressure > 100 mmHg |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Hungary, Netherlands, Poland, Slovakia |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01302145 |
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Other Study ID Numbers | 1941-CL-0056 |
Has Data Monitoring Committee | No |
Information Provided By | Astellas Pharma Inc |
Study Sponsor | Astellas Pharma Inc |
Collaborators | Not Provided |
Investigators | Study Director: Use Central Contact Astellas Pharma Europe B.V. |
Verification Date | February 2011 |
Locations[ + expand ][ + ]
Hungary | Balatonfured, Hungary, 8230 |
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Hungary | Budapest, Hungary, 1083 |
Netherlands | Groningen, Netherlands, 9470 AE |
Poland | Warsaw, Poland, 02-097 |
Slovakia | Bratislava, Slovakia, 83305 |