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Drug to Drug Interaction Study With ASP1941 and Metformin

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01302145
First received: February 21, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: ASP1941
Drug: Metformin
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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 ]

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 ]

Enrollment: 36
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 + metformin Drug: ASP1941
Tablet
Drug: Metformin
Tablet
Placebo Comparator: Placebo + metformin Drug: Metformin
Tablet
Drug: Placebo
Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302145

Locations
Hungary
Balatonfured, Hungary, 8230
Budapest, Hungary, 1083
Netherlands
Groningen, Netherlands, 9470 AE
Poland
Warsaw, Poland, 02-097
Slovakia
Bratislava, Slovakia, 83305
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe BV
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01302145     History of Changes
Other Study ID Numbers: 1941-CL-0056, 2007-005614-39
Study First Received: February 21, 2011
Last Updated: February 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
ASP1941
Drug to drug interaction
metformin
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013