Drug to Drug Interaction Study With ASP1941 and Metformin | RxWiki

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.
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
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	Pharmacodynamics assessed by serum glucose change [Time Frame: 5 weeks] [Designated as safety issue: No] Pharmacokinetics assessed by metformin plasma concentration change [Time Frame: 5 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Drug to Drug Interaction Study With ASP1941 and Metformin
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)	Experimental: ASP1941 + metformin Placebo Comparator: Placebo + metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
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
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

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