A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01071850

Collaborator

(none)

412

Enrollment

Locations

Arms

13.3

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: ipragliflozin Drug: Metformin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

412 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus

Actual Study Start Date :

Mar 3, 2010

Actual Primary Completion Date :

Apr 11, 2011

Actual Study Completion Date :

Apr 11, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1941 lowest dose oral tablet	Drug: ipragliflozin oral tablet Other Names: ASP1941
Experimental: ASP1941 low dose oral tablet	Drug: ipragliflozin oral tablet Other Names: ASP1941
Experimental: ASP1941 high dose oral tablet	Drug: ipragliflozin oral tablet Other Names: ASP1941
Experimental: ASP1941 highest dose oral tablet	Drug: ipragliflozin oral tablet Other Names: ASP1941
Active Comparator: Metformin oral tablet	Drug: Metformin oral tablet
Placebo Comparator: Placebo oral tablet	Drug: Placebo oral tablet

Outcome Measures

Primary Outcome Measures

Mean change from baseline in Hemoglobin A1c (HbA1c) [12 weeks]

Secondary Outcome Measures

Mean change from baseline in fasting plasma glucose (FPG) [12 weeks]
Proportion of subjects achieving target goal of HbA1c <7.0% [12 weeks]
Proportion of subjects achieving target goal of HbA1c <6.5% [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has been diagnosed with type 2 diabetes
Subject has a HbA1c value between 6.8 and 9.5%
Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
Subject is on a stable diet and exercise program
Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study

Exclusion Criteria:

Subject has type 1 diabetes mellitus
Subject is using insulin therapy
Subject has a serum creatinine higher than upper limit of normal
Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
Subject has persistent, uncontrolled severe hypertension as indicated by a

systolic blood pressure >180 mmHg or a diastolic blood pressure of

110mmHg

Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
Subject is known to have hepatitis or be a carrier of hepatitis B surface

antigen, hepatitis C virus antibody or is known positive for HIV1 and/or

HIV2

Subject has a history of lactic acidosis
Subject has a history of drug and alcohol abuse/dependency within last 12

months

Subject has had a malignancy in the last 5 years, except for successfully

treated basal or squamous cell carcinoma of the skin or of the cervix

Subject has a symptomatic urinary tract infection or genital infection
Female subject is lactating
Subject has an unstable medical or psychiatric illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkway Medical Center	Birmingham	Alabama	United States	35215
2	Winston Technology Research, LLC	Haleyville	Alabama	United States	35565
3	Desert Clinical Research	Mesa	Arizona	United States	85213
4	Central Phoenix Medical Clinic	Phoenix	Arizona	United States	85020
5	Paul W. Davis, MD, PA	Pine Bluff	Arkansas	United States	71603
6	Clinical Innovations, Inc.	Costa Mesa	California	United States	92626
7	Del Rosario Medical Clinic, Inc	Huntington Park	California	United States	90255
8	Torrance Clinical Research	Lomita	California	United States	90717
9	San Diego Managed Care Group Clinical Research	San Diego	California	United States	92128
10	Expresscare Clinical Research	Colorado Springs	Colorado	United States	80909
11	PAB Clinical Research	Brandon	Florida	United States	33511
12	Clinical Therapeutics Corp.	Coral Gables	Florida	United States	33131
13	A.G.A Clinical Trials DBA Neostart Group	Hialeah	Florida	United States	33012
14	Suncoast Clinical Research	New Port Richey	Florida	United States	34652
15	CSRA Partners in Health, Inc.	Augusta	Georgia	United States	30909
16	Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.	Tucker	Georgia	United States	30084
17	Cedar Crosse Research Center	Chicago	Illinois	United States	60607
18	APEX Medical Research, AMR, Inc	Chicago	Illinois	United States	60616
19	MediSphere Medical Research	Evansville	Indiana	United States	47714
20	Bay West Endocrinology	Towson	Maryland	United States	21204
21	Prism Research	Saint Paul	Minnesota	United States	55114
22	PMG Research of Charlotte, LLC	Charlotte	North Carolina	United States	28209
23	PMG Research of Salisbury, LLC	Salisbury	North Carolina	United States	28144
24	Rapid Medical Research	Cleveland	Ohio	United States	44122
25	Primecare of Southeastern Ohio, Inc.	Zanesville	Ohio	United States	43701
26	Integris Family Care	Yukon	Oklahoma	United States	73099
27	Willamette Valley Clinical Studies	Eugene	Oregon	United States	97404
28	Fleetwood Clinical Research	Fleetwood	Pennsylvania	United States	19522
29	Southeastern Research Associates, Inc.	Taylors	South Carolina	United States	29687
30	PMG Research of Bristol, LLC	Bristol	Tennessee	United States	37620
31	Holston Medical Group	Kingsport	Tennessee	United States	37660
32	Southwind Medical Specialist	Memphis	Tennessee	United States	38125
33	Punzi Medical Center	Carrollton	Texas	United States	75006
34	Corpus Christi Family Wellness Center	Corpus Christi	Texas	United States	78414
35	Excel Clinical Research, LLC	Houston	Texas	United States	77081
36	Cetero Research	San Antonio	Texas	United States	78229
37	Aspen Clinical Research	Orem	Utah	United States	84058
38	BIOMELAB	Barranquilla		Colombia
39	Centro de Reumatologia y ortopedia	Barranquilla		Colombia
40	Fundacion de Caribe para le Investigacion Biomedica	Barranquilla		Colombia
41	Dexa Diad Servicios Medicos	Bogota		Colombia
42	School of Medicine University of Rosario	Bogota		Colombia
43	Fundacion Cardiovascular de Columbia	Floridablanca Santander		Colombia
44	Diacon Hospital	Bangalore		India	560010
45	Hormone Care and Research Centre	Ghaziabad		India	201002
46	TOTALL Diabetes Hormone Institute Pvt.Ltd.	Indore		India	452001
47	S R Kalla Memorial Gastro & General Hospital	Jaipur		India	302001
48	Bride, Bharti Hospital	Karnal		India	132001
49	Amrita Institute of Medical Sciences and Research Centre, AIMS	Kerala		India	682041
50	Unidad Metabólica y Cardiovascular, SC.	Cuernavaca		Mexico	62250
51	Instituto Jaliscience de Investigacion Clinica	Guadalajara		Mexico	44100
52	Torre Medica Providencia	Guadalajara		Mexico	44670
53	Medical Care and Research	Merida		Mexico	97070
54	CEDIME, Instituto Vascular	Merida		Mexico	97129
55	Hospital Universitario Dr. Eleuterio Gonzalez	Monterrey		Mexico	66460
56	Cebu Doctors' University Hospital	Cebu		Philippines	6000
57	St. Paul's Hospital	Iloilo City		Philippines	5000
58	Amang Rodriguez Memorial Medical Center	Marikina City		Philippines	1800
59	San Juan De Dios Hospital	Pasay City		Philippines	1300