A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00263276

Collaborator

Bristol-Myers Squibb (Industry)

389

Enrollment

145

Locations

Arms

Duration (Months)

2.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: dapagliflozin Drug: dapagliflozin Drug: dapagliflozin Drug: dapagliflozin Drug: dapagliflozin Drug: placebo Drug: metformin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

389 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: dapagliflozin Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Experimental: Arm 2	Drug: dapagliflozin Tablets, Oral, 5 mg, Once daily, 12 weeks.
Experimental: Arm 3	Drug: dapagliflozin Tablets, Oral, 10 mg, Once daily, 12 weeks.
Experimental: Arm 4	Drug: dapagliflozin Tablets, Oral, 20 mg, Once daily, 12 weeks.
Experimental: Arm 5	Drug: dapagliflozin Tablets, Oral, 50 mg, Once daily, 12 weeks.
Placebo Comparator: Arm 6	Drug: placebo Tablets, Oral, 0 mg, Once daily, 12 weeks.
Active Comparator: Arm 7	Drug: metformin Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.

Outcome Measures

Primary Outcome Measures

Mean change from baseline in HbA1c compared to placebo. [at 12 weeks]

Secondary Outcome Measures

Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion [at Weeks 6 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
C-peptide > 1.0 ng/ml
Body Mass Index <= 40 kg/m2
Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

Exclusion Criteria:

Unstable renal disease
Patients with significant liver disease including chronic active hepatitis
Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
Subjects with clinically significant anemia

Contacts and Locations

Locations

	Site	City	State	Country
1	Local Institution	Bayou La Batre	Alabama	United States
2	Local Institution	Birmingham	Alabama	United States
3	Local Institution	Huntsville	Alabama	United States
4	Local Institution	Mobile	Alabama	United States
5	Local Institution	Chandler	Arizona	United States
6	Local Institution	Tucson	Arizona	United States
7	Local Institution	Fayetteville	Arkansas	United States
8	Local Institution	Hot Springs	Arkansas	United States
9	Local Institution	Beverly Hills	California	United States
10	Local Institution	Long Beach	California	United States
11	Local Institution	Los Gatos	California	United States
12	Local Institution	Mission Viejo	California	United States
13	Local Institution	Orange	California	United States
14	Local Institution	Redondo Beach	California	United States
15	Local Institution	San Diego	California	United States
16	Local Institution	Torrance	California	United States
17	Local Institution	Colorado Springs	Colorado	United States
18	Local Institution	Denver	Colorado	United States
19	Local Institution	Boynton Beach	Florida	United States
20	Local Institution	Brandon	Florida	United States
21	Local Institution	Delray Beach	Florida	United States
22	Local Institution	Holly Hill	Florida	United States
23	Local Institution	Jacksonville	Florida	United States
24	Local Instiuttion	Jacksonville	Florida	United States
25	Local Institution	New Port Richey	Florida	United States
26	Local Institution	Orlando	Florida	United States
27	Local Institution	Ormond Beach	Florida	United States
28	Local Institution	Augusta	Georgia	United States
29	Local Institution	Blue Ridge	Georgia	United States
30	Local Institution	Honolulu	Hawaii	United States
31	Local Institution	Indianapolis	Indiana	United States
32	Local Institution	Lafayette	Indiana	United States
33	Local Institution	Arkansas City	Kansas	United States
34	Local Institution	Baton Rouge	Louisiana	United States
35	Local Institution	Columbia	Maryland	United States
36	Local Institution	Elkton	Maryland	United States
37	Local Institution	Sudbury	Massachusetts	United States
38	Local Institution	Worcester	Massachusetts	United States
39	Local Institution	Dearborn	Michigan	United States
40	Local Institution	Royal Oak	Michigan	United States
41	Local Institution	Brooklyn Center	Minnesota	United States
42	Local Insitution	Edina	Minnesota	United States
43	Local Institution	Minneapolis	Minnesota	United States
44	Local Institution	Hattiesburg	Mississippi	United States
45	Local Institution	Jackson	Mississippi	United States
46	Local Institution	Chesterfield	Missouri	United States
47	Local Institution	Kansas City	Missouri	United States
48	Local Institution	St. Louis	Missouri	United States
49	Local Institution	Scottsbluff	Nebraska	United States
50	Local Institution	North Las Vegas	Nevada	United States
51	Local Institution	Albuquerque	New Mexico	United States
52	Local Institution	Alburquerque	New Mexico	United States
53	Local Institution	Los Alamos	New Mexico	United States
54	Local Institution	Albany	New York	United States
55	Local Institution	Bronxville	New York	United States
56	Local Institution	Camillus	New York	United States
57	Local Institution	Cooperstown	New York	United States
58	Local Instiution	New Hyde Park	New York	United States
59	Local Institution	West Seneca	New York	United States
60	Local Institution	Charlotte	North Carolina	United States
61	Local Institution	High Point	North Carolina	United States
62	Local Institution	Morehead City	North Carolina	United States
63	Local Institution	Raleigh	North Carolina	United States
64	Local Institution	Wilmington	North Carolina	United States
65	Local Institution	Akron	Ohio	United States
66	Local Institution	Beachwood	Ohio	United States
67	Local Institution	Cincinnati	Ohio	United States
68	Local Institution	Cleveland	Ohio	United States
69	Local Institution	Dayton	Ohio	United States
70	Local Institution	Mogadore	Ohio	United States
71	Local Institution	Newark	Ohio	United States
72	Local Institution	Zanesville	Ohio	United States
73	Local Institution	Bethany	Oklahoma	United States
74	Local Institution	Yukon	Oklahoma	United States
75	Local Institution	Bend	Oregon	United States
76	Local Institution	Eugene	Oregon	United States
77	Local Institution	Hillsboro	Oregon	United States
78	Local Institution	Portland	Oregon	United States
79	Local Institution	Bensalem	Pennsylvania	United States
80	Local Institution	Feasterville	Pennsylvania	United States
81	Local Institution	Levittown	Pennsylvania	United States
82	Local Institution	Morrisville	Pennsylvania	United States
83	Local Institution	Reading	Pennsylvania	United States
84	Local Institution	Cumberland	Rhode Island	United States
85	Local Institution	Johnston	Rhode Island	United States
86	Local Institution	Anderson	South Carolina	United States
87	Local Institution	Simpsonville	South Carolina	United States
88	Local Institution	Summerville	South Carolina	United States
89	Local Institution	Taylors	South Carolina	United States
90	Local Institution	Rapid City	South Dakota	United States
91	Local Institution	Memphis	Tennessee	United States
92	Local Institution	Nashville	Tennessee	United States
93	Local Institution	Selmer	Tennessee	United States
94	Local Institution	Austin	Texas	United States
95	Local Institution	Bellaire	Texas	United States
96	Local Institution	Bryan	Texas	United States
97	Local Institution	El Paso	Texas	United States
98	Local Institution	Houston	Texas	United States
99	Local Institution	Irving	Texas	United States
100	Local Institution	San Antonio	Texas	United States
101	Local Institution	Salt Lake City	Utah	United States
102	Local Institution	Burke	Virginia	United States
103	Local Institution	Hampton	Virginia	United States
104	Local Institution	Norfolk	Virginia	United States
105	Local Institution	Richmond	Virginia	United States
106	Local Institution	Virginia Beach	Virginia	United States
107	Local Institution	Edmonds	Washington	United States
108	Local Institution	Renton	Washington	United States
109	Local Institution	Spokane	Washington	United States
110	Local Institution	Vancouver	Washington	United States
111	Local Institution	Milwaukee	Wisconsin	United States
112	Local Institution	West Allis	Wisconsin	United States
113	Local Institution	Calgary	Alberta	Canada
114	Local Institution	Edmonton	Alberta	Canada
115	Local Institution	Langley	British Columbia	Canada
116	Local Institution	Surrey	British Columbia	Canada
117	Local Institution	Vancouver	British Columbia	Canada
118	Local Institution	Winnipeg	Manitoba	Canada
119	Local institution	Bathurst	New Brunswick	Canada
120	Local Institution	Moncton	New Brunswick	Canada
121	Local Institution	St. John's	New Brunswick	Canada
122	Local Institution	St. John's	Newfoundland and Labrador	Canada
123	Local Institution	Corunna	Ontario	Canada
124	Local Institution	Etobicoke	Ontario	Canada
125	Local Institution	Kitchener	Ontario	Canada
126	Local Institution	Newmarket	Ontario	Canada
127	Local Institution	Sarnia	Ontario	Canada
128	Local Institution	Toronto	Ontario	Canada
129	Local Institution	Charlottetown	Prince Edward Island	Canada
130	Local Institution	Drummondville	Quebec	Canada
131	Local Institution	Granby	Quebec	Canada
132	Local Institution	Greenfield Park	Quebec	Canada
133	Local Institution	Rimouski	Quebec	Canada
134	Local Institution	St-Leonard	Quebec	Canada
135	Local Institution	Ste-Foy	Quebec	Canada
136	Local Institution	Saskatoon	Saskatchewan	Canada
137	Local Institution	Guadalajara	Jalisco	Mexico
138	Local Institution	Zapopan	Jalisco	Mexico
139	Local Institution	Cuernavaca	Morelos	Mexico
140	Local Institution	Monterrey	Nuevo Leon	Mexico
141	Local Institution	Aguascalientes		Mexico
142	Local Institution	Durango		Mexico
143	Local Institution	Caguas		Puerto Rico
144	Local Institution	Manati		Puerto Rico
145	Local Institution	San Juan		Puerto Rico