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A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01316107
First Posted: March 16, 2011
Last Update Posted: January 20, 2016
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
March 14, 2011
March 16, 2011
January 20, 2016
February 2011
December 2012   (Final data collection date for primary outcome measure)
change from baseline in hemoglobin A1c (HbA1c) [ Time Frame: baseline and for 24 weeks ]
Same as current
Complete list of historical versions of study NCT01316107 on ClinicalTrials.gov Archive Site
  • change from baseline in fasting plasma glucose [ Time Frame: baseline and for 24 weeks ]
  • change from baseline in fasting serum insulin [ Time Frame: baseline and for 24 weeks ]
  • Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: for 52 weeks ]
Same as current
Not Provided
Not Provided
 
A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients
A Phase 3, Open-Label, Non-comparative Study to Assess the Long-Term Safety, Tolerability and Efficacy of ASP1941 in Combination With Nateglinide in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Nateglinide Alone
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.
This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: ASP1941
    oral
  • Drug: nateglinide
    oral
    Other Name: Starsis, Fastic
Experimental: ASP group
Concomitant administration of ASP1941 and nateglinide
Interventions:
  • Drug: ASP1941
  • Drug: nateglinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
  • HbA1c value between 6.5 and 9.5%
  • Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

  • Type 1 diabetes mellitus patients
  • Serum creatinine > upper limit of normal
  • Proteinuria (albumin/creatinine ratio > 300mg/g)
  • Dysuria and/or urinary tract infection, genital infection
  • Significant renal, hepatic or cardiovascular diseases
  • Severe gastrointestinal diseases
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01316107
1941-CL-0111
No
Not Provided
Plan to Share IPD: Undecided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2016

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