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

Overview[ - collapse ][ - ]

Purpose This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.
ConditionType 2 Diabetes Mellitus
InterventionDrug: ASP1941
Drug: Placebo
Drug: metformin
PhasePhase 3
SponsorAstellas Pharma Inc
Responsible PartyAstellas Pharma Inc
ClinicalTrials.gov IdentifierNCT01135433
First ReceivedJune 1, 2010
Last UpdatedJanuary 10, 2012
Last verifiedJanuary 2012

Tracking Information[ + expand ][ + ]

First Received DateJune 1, 2010
Last Updated DateJanuary 10, 2012
Start DateMay 2010
Estimated Primary Completion DateDecember 2011
Current Primary Outcome MeasuresChange from baseline in HbA1c [Time Frame: Baseline and for 24 weeks] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients
Official TitleA Phase 3, Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
Brief Summary
This study is to evaluate the efficacy and safety after concomitant administration of
ASP1941 and metformin in patients with diabetes mellitus.
Detailed Description
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in
combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have
inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with
those of placebo.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: ASP1941
oral
Drug: Placebo
oral
Drug: metformin
oral
Other Names:
  • Melbin
  • Grycoran
  • Metgluco
Study Arm (s)
  • Experimental: ASP group
    ASP1941 and metformin
  • Placebo Comparator: Placebo group
    placebo and metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment168
Estimated Completion DateDecember 2011
Estimated Primary Completion DateDecember 2011
Eligibility Criteria
Inclusion Criteria:

- Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 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

- Estimated GFR < 60ml/min/1.73m2

- Proteinuria (albumin/creatinine ratio > 300mg/g)

- Dysuria and/or urinary tract infection, genital infection

- Significant renal, hepatic or cardiovascular diseases

- Severe gastrointestinal diseases
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesJapan

Administrative Information[ + expand ][ + ]

NCT Number NCT01135433
Other Study ID Numbers1941-CL-0106
Has Data Monitoring CommitteeNo
Information Provided ByAstellas Pharma Inc
Study SponsorAstellas Pharma Inc
CollaboratorsNot Provided
Investigators Study Chair: Use Central Contact Astellas Pharma Inc
Verification DateJanuary 2012

Locations[ + expand ][ + ]

Japan
Chubu, Japan
Japan
Chugoku, Japan
Japan
Hokkaido, Japan
Japan
Kansai, Japan
Japan
Kantou, Japan
Japan
Kyushu, Japan
Japan
Touhoku, Japan