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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01225081
First received: October 19, 2010
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: ASP1941
Drug: Placebo
Drug: Pioglitazone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Pioglitazone in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone 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 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: 152
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP group
ASP1941 and pioglitazone
Drug: ASP1941
oral
Drug: Pioglitazone
oral
Other Name: Actos
Placebo Comparator: Placebo group
placebo and pioglitazone
Drug: Placebo
oral
Drug: Pioglitazone
oral
Other Name: Actos

Detailed Description:

This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

  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 pioglitazone mono-therapy for at least 4 weeks
  • HbA1c value between 7.0 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
  • Heart failure patients
  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: NCT01225081

Locations
Japan
Chubu, Japan
Chugoku, 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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01225081     History of Changes
Other Study ID Numbers: 1941-CL-0107
Study First Received: October 19, 2010
Last Updated: May 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
pioglitazone

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

ClinicalTrials.gov processed this record on August 21, 2014