We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Drug to Drug Interaction Study With ASP1941 and Metformin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302145
First Posted: February 23, 2011
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
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

Resource links provided by NLM:


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 ]

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

Enrollment: 36
Actual Study Start Date: February 25, 2009
Study Completion Date: December 9, 2009
Primary Completion Date: December 9, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 + metformin
Oral
Drug: ASP1941
Tablet
Drug: Metformin
Tablet
Placebo Comparator: Placebo + metformin
Oral
Drug: Metformin
Tablet
Drug: Placebo
Tablet

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: February 21, 2011
First Posted: February 23, 2011
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