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A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242228
First Posted: November 16, 2010
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
  Purpose
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Drug: DPP-4 inhibitor Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 an DPP-4 Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With a DPP-4 Inhibitor Alone.

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: baseline and 52 weeks ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: baseline and 52 weeks ]
  • Change from baseline in fasting serum insulin [ Time Frame: baseline and 52 weeks ]
  • Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) [ Time Frame: for 52 weeks ]

Enrollment: 106
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP group
Concomitant administration of ASP1941 and DPP-4 inhibitor
Drug: ASP1941
oral
Drug: DPP-4 inhibitor
oral
Other Name: Sitagliptin, Arogliptin, Vildagliptin, Saxagliptin

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 a DPP-4 inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
  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:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients receiving with DPP-4 inhibitor 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
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): NCT01242228


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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01242228     History of Changes
Other Study ID Numbers: 1941-CL-0110
First Submitted: November 15, 2010
First Posted: November 16, 2010
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
Dipeptidyl peptidase-4 inhibitor
DPP-4 inhibitor
long-term safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs