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Drug to Drug Interaction Study With ASP1941 and Metformin

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ClinicalTrials.gov Identifier: NCT01302145
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Drug: Metformin Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : February 25, 2009
Primary Completion Date : December 9, 2009
Study Completion Date : December 9, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ASP1941 + metformin
Oral
Drug: ASP1941
Tablet
Drug: Metformin
Tablet
Placebo Comparator: Placebo + metformin
Oral
Drug: Metformin
Tablet
Drug: Placebo
Tablet


Outcome Measures

Primary Outcome Measures :
  1. Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Pharmacodynamics assessed by serum glucose change [ Time Frame: 5 weeks ]
  2. Pharmacokinetics assessed by metformin plasma concentration change [ Time Frame: 5 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 B.V.
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01302145     History of Changes
Other Study ID Numbers: 1941-CL-0056
2007-005614-39 ( EudraCT Number )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

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

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