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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01316107
First received: March 14, 2011
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: ASP1941
Drug: nateglinide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • change from baseline in hemoglobin A1c (HbA1c) [ Time Frame: baseline and for 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in fasting plasma glucose [ Time Frame: baseline and for 24 weeks ] [ Designated as safety issue: No ]
  • change from baseline in fasting serum insulin [ Time Frame: baseline and for 24 weeks ] [ Designated as safety issue: No ]
  • Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: for 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP group
Concomitant administration of ASP1941 and nateglinide
Drug: ASP1941
oral
Drug: nateglinide
oral
Other Name: Starsis, Fastic

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316107

Locations
Japan
Hokkaido, Japan
Kantou, Japan
Kyushu, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01316107     History of Changes
Other Study ID Numbers: 1941-CL-0111
Study First Received: March 14, 2011
Last Updated: October 16, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
nateglinide
long-term safety

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

ClinicalTrials.gov processed this record on October 23, 2014