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

February 21, 2011
February 21, 2011
February 2009
December 2009   (final data collection date for primary outcome measure)
Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Drug to Drug Interaction Study With ASP1941 and Metformin
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: ASP1941
    Tablet
  • Drug: Metformin
    Tablet
  • Drug: Placebo
    Tablet
  • Experimental: ASP1941 + metformin
    Interventions:
    • Drug: ASP1941
    • Drug: Metformin
  • Placebo Comparator: Placebo + metformin
    Interventions:
    • Drug: Metformin
    • Drug: Placebo
Veltkamp SA, van Dijk J, Collins C, van Bruijnsvoort M, Kadokura T, Smulders RA. Combination treatment with ipragliflozin and metformin: a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Clin Ther. 2012 Aug;34(8):1761-71. doi: 10.1016/j.clinthera.2012.06.027. Epub 2012 Jul 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Netherlands,   Poland,   Slovakia
 
NCT01302145
1941-CL-0056, 2007-005614-39
No
Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP