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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01242215
First received: November 15, 2010
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Device: ASP1941
Drug: Placebo
Drug: Sulfonylurea
 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 Sulfonylurea in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Alone

Resource links provided by NLM:

Drug Information available for: Glyburide
U.S. FDA Resources

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: 243
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 sulfonylurea
 Device: ASP1941
oral
Drug: Sulfonylurea
oral
Other Name: Glibenclamide, Gliclazide, Glimepiride
Placebo Comparator: Placebo group
placebo and sulfonylurea
 Drug: Placebo
oral
Drug: Sulfonylurea
oral
Other Name: Glibenclamide, Gliclazide, Glimepiride

Detailed Description:

This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea 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 with sulfonylurea 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242215

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: NCT01242215     History of Changes
Other Study ID Numbers: 1941-CL-0109
Study First Received: November 15, 2010
Last Updated: May 23, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
sulfonylurea

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

ClinicalTrials.gov processed this record on May 19, 2013