A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-group, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452632
• Other study ID #: 1941-CL-2009
• Status: Completed
• Phase: Phase 3
• Start date: June 22, 2015
• Est. completion date: January 5, 2017

Study information

• Verified date: November 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin and sitagliptin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: January 5, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

Inclusion Criteria:

• Subject has been diagnosed with type 2 diabetes mellitus.

• Subject has an HbA1c value between 7.0% and 10.5 % at visit 1.

• Subject shows FPG (Fasting Plasma Glucose) value is less than 270mg/dL.

• Subject shows a BMI of 20.0 to 45.0 kg/m2.

• Subject is on stable diet and exercise program at least 8 weeks prior to study participation.

• Postmenopausal female or surgically sterile female or agree not to become pregnant.

Exclusion Criteria:

• Subject has type 1 diabetes mellitus.

• Subject has proliferative diabetic retinopathy.

• Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, or renal transplant.

• Subject has significant dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy etc.

• Subject has a symptomatic urinary tract infection or genital infection.

• Subject has chronic disease(s) that require the continuous use of systemic corticosteroids or immunosuppressants.

• Subject has cardiovascular disease or cerebrovascular disease that may affect the administration of ASP1941 or its safety assessment in the opinion of the investigator or sub-investigator.

• Subject has uncontrollable psychiatric disorder(s) with medication.

• Male subject is not willing to use appropriate contraception during the study.

• Subject has severe infection, serious trauma, or perioperative subject.

• Subject has a malignant tumor or has a history of malignant tumor.

• Subject has severe gastrointestinal disease, or history of operation for serious gastrointestinal disease.

• Subject has diabetic ketoacidosis.

• Subject has lactic acidosis or has history of lactic acidosis.

• Subject has hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is positive for HIV-1 and/or HIV-2.

• Subject has a history of thyroid dysfunction and acute pancreatitis.

• Subject is on weight-loss program or weight-loss medication (e.g. orlistat, phentermine/topiramate, lorcaserin) within 12 weeks of study participation.

• Subject has a history of serious cardiac diseases (NYHA Class III to IV), congestive heart failure, arrhythmia in need of medical treatment.

• Subject has a history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, within 52 weeks (364 days) of study participation.

• Subject has uncontrollable severe hypertension, i.e., systolic blood pressure of higher than 180 mmHg or diastolic blood pressure of higher than 110mmHg measured in a sitting position after a 5-minute rest.

• Subject has following AST or ALT value:

• AST: Male > 100 U/L, Female > 80 U/L

• ALT: Male > 102.5 U/L, Female > 82.5 U/L

• Subject has following serum creatinine value:

• Creatinine: Male > 1.3 mg/dL, Female > 1.2 mg/dL

• Subject has estimated GFR values, of < 60 mL/min/1.73m2.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ASP1941
oral
• Placebo
oral

Locations

Country	Name	City	State
Korea, Republic of	Site KR00002	Busan
Korea, Republic of	Site KR00003	Busan
Korea, Republic of	Site KR00007	Daegu
Korea, Republic of	Site KR00011	Daegu
Korea, Republic of	Site KR00019	Dong Gu Gwangju
Korea, Republic of	Site KR00008	Gangwon-do
Korea, Republic of	Site KR00018	Gyeonggi-do
Korea, Republic of	Site KR00022	Gyeonggi-do
Korea, Republic of	Site KR00014	Incheon
Korea, Republic of	Site KR00020	Jeollabuk-do
Korea, Republic of	Site KR00021	Kyungsangnam-do
Korea, Republic of	Site KR00001	Seoul
Korea, Republic of	Site KR00004	Seoul
Korea, Republic of	Site KR00005	Seoul
Korea, Republic of	Site KR00006	Seoul
Korea, Republic of	Site KR00009	Seoul
Korea, Republic of	Site KR00010	Seoul
Korea, Republic of	Site KR00012	Seoul
Korea, Republic of	Site KR00013	Seoul
Korea, Republic of	Site KR00016	Seoul
Korea, Republic of	Site KR00017	Seoul
Korea, Republic of	Site KR00015	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at the end of treatment		at 24 weeks
Secondary	Change from baseline in Fasting plasma glucose at the end of treatment		at 24 weeks
Secondary	Change from baseline in Fasting serum insulin at the end of treatment		at 24 weeks
Secondary	Change from baseline in Body weight at the end of treatment		at 24 weeks
Secondary	Change from baseline in Waist circumference at the end of treatment		at 24 weeks
Secondary	Safety assessed by development of adverse events, vital signs, laboratory tests, and 12-lead ECG	ECG: Electrocardiogram	up to 24 weeks
Secondary	Number of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit		at 4, 8, 12, 16 and 24 weeks
Secondary	Percentage of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit		at 4, 8, 12, 16 and 24 weeks

External Links

•   Link to results on the Astellas Clinical Study Results website