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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01505426
Other study ID # 1941-CL-2004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 28, 2011
Est. completion date January 14, 2013

Study information

Verified date October 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date January 14, 2013
Est. primary completion date January 14, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study

- Stable diet and exercise program for at least 8 weeks before the study

- On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin

- BMI of 20.0 to 45.0 kg/m2

- A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

Exclusion Criteria:

- Type 1 diabetes mellitus

- Proliferative diabetic retinopathy

- Receiving insulin within 12 weeks prior to the study

- History of clinically significant renal disease(s)

- Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.

- Urinary tract infection or genital infection

- Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics

- History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study

- Severe infection, serious trauma, or perioperative subject

- Known or suspected hypersensitivity to ASP1941

- History of treatment with ASP1941

- Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study

- Serum creatinine value exceeding the upper limit of normal range

- Urinary microalbumin/urinary creatinine ratio >300 mg/g

Study Design


Intervention

Drug:
ASP1941
oral
metformin
oral, concomitant use
Placebo
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c from baseline to end of treatment Baseline and up to 24 weeks
Secondary Change in fasting plasma glucose level Baseline and up to 24 weeks
Secondary Change in fasting serum insulin level Baseline and up to 24 weeks
Secondary Change in body weight Baseline and up to 24 weeks
Secondary Change in waist circumference Baseline and up to 24 weeks
Secondary Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG For 24 weeks
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