A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00246987
• Collaborator: (none)
• Enrollment: 341
• Locations: 130
• Duration (Months): 10
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.

Condition or Disease	Intervention/Treatment	Phase
Diabetes, Type 2	Drug: Muraglitazar	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
• Study Start Date: Jun 1, 2003
• Actual Study Completion Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c from baseline to Week 24 []

Secondary Outcome Measures

1. Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with Type 2 diabetes

• Drug Naive

• HbA1c >= 7.0% and <= 10.0%

• Body Mass Index <= 41 kg/m2

• Serum TG <= 600 mg/dL

Exclusion Criteria:

• Symptomatic Type 2 diabetes

• History of bladder cancer

• History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Anniston	Alabama	United States
2	Local Institution	Birmingham	Alabama	United States
3	Local Institution	Haleyville	Alabama	United States
4	Local Institution	Hoover	Alabama	United States
5	Local Institution	Fayetteville	Arizona	United States
6	Local Institution	Hot Springs	Arizona	United States
7	Local Institution	Mesa	Arizona	United States
8	Local Institution	Phoenix	Arizona	United States
9	Local Institution	Tucson	Arizona	United States
10	Local Institution	Tulsa	Arizona	United States
11	Local Institution	Concord	California	United States
12	Local Institution	Fountain Valley	California	United States
13	Local Institution	Long Beach	California	United States
14	Local Institution	Los Gatos	California	United States
15	Local Institution	Raleigh	California	United States
16	Local Institution	Roseville	California	United States
17	Local Institution	San Diego	California	United States
18	Local Institution	Spring Valley	California	United States
19	Local Institution	Tustin	California	United States
20	Local Institution	Colorado Springs	Colorado	United States
21	Local Institution	Golden	Colorado	United States
22	Local Institution	Littleton	Colorado	United States
23	Local Institution	New Britain	Connecticut	United States
24	Local Institution	Altamonte Springs	Florida	United States
25	Local Institution	Brandon	Florida	United States
26	Local Institution	Chipley	Florida	United States
27	Local Institution	Coral Gables	Florida	United States
28	Local Institution	Kissimmee	Florida	United States
29	Local Institution	Longwood	Florida	United States
30	Local Institution	Melbourne	Florida	United States
31	Local Institution	New Port Richie	Florida	United States
32	Local Institution	Ocala	Florida	United States
33	Local Institution	Pinellas Park	Florida	United States
34	Local Institution	Chicago	Illinois	United States
35	Local Institution	Overland Park	Kansas	United States
36	Local Institution	Shawnee Mission	Kansas	United States
37	Local Institution	Lexington	Kentucky	United States
38	Local Institution	Madisonville	Kentucky	United States
39	Local Institution	Shreveport	Louisiana	United States
40	Local Institution	Gulfport	Mississippi	United States
41	Local Institution	St. Peters	Mississippi	United States
42	Local Institution	Chesterfield	Missouri	United States
43	Local Institution	Kansas City	Missouri	United States
44	Local Institution	Springfield	Missouri	United States
45	Local Institution	Elizabeth	New Jersey	United States
46	Local Institution	Toms River	New Jersey	United States
47	Local Institution	Endwell	New York	United States
48	Local Institution	West Seneca	New York	United States
49	Local Institution	Charlotte	North Carolina	United States
50	Local Institution	High Point	North Carolina	United States
51	Local Institution	Morehead City	North Carolina	United States
52	Local Institution	Salisbury	North Carolina	United States
53	Local Institution	Winston Salem	North Carolina	United States
54	Local Institution	Franklin	Ohio	United States
55	Local Institution	Newark	Ohio	United States
56	Local Institution	Zanesville	Ohio	United States
57	Local Institution	Eugene	Oregon	United States
58	Local Institution	Portland	Oregon	United States
59	Local Institution	Philadelphia	Pennsylvania	United States
60	Local Institution	Reading	Pennsylvania	United States
61	Local Institution	Warminster	Pennsylvania	United States
62	Local Institution	East Providence	Rhode Island	United States
63	Local Institution	Johnston	Rhode Island	United States
64	Local Institution	Providence	Rhode Island	United States
65	Local Institution	Anderson	South Carolina	United States
66	Local Institution	Greer	South Carolina	United States
67	Local Institution	Mount Pleasant	South Carolina	United States
68	Local Institution	Knoxville	Tennessee	United States
69	Local Institution	Memphis	Tennessee	United States
70	Local Institution	Fort Worth	Texas	United States
71	Local Institution	Lubbock	Texas	United States
72	Local Institution	San Angelo	Texas	United States
73	Local Institution	San Antonio	Texas	United States
74	Local Institution	Salt Lake City	Utah	United States
75	Local Institution	Richmond	Virginia	United States
76	Local Institution	Virginia Beach	Virginia	United States
77	Local Institution	Edmonds	Washington	United States
78	Local Institution	Federal Way	Washington	United States
79	Local Institution	Olympia	Washington	United States
80	Local Institution	Spokane	Washington	United States
81	Local Institution	Vancouver	Washington	United States
82	Local Institution	Milwaukee	Wisconsin	United States
83	Local Institution	Canberra	New South Wales	Australia
84	Local Institution	Sydney	New South Wales	Australia
85	Local Institution	Wollongong	New South Wales	Australia
86	Local Institution	Kippa Ring	Queensland	Australia
87	Local Institution	Meadowbrook	Queensland	Australia
88	Local Institution	Adelaide	South Australia	Australia
89	Local Institution	Woodville	South Australia	Australia
90	Local Institution	Launceston	Tasmania	Australia
91	Tasmania	Melbourne	Victoria	Australia
92	Local Institution	Calgary	Alberta	Canada
93	Local Institution	Edmonton	Alberta	Canada
94	Local Institution	Coquitlam	British Columbia	Canada
95	Local Institution	Winnipeg	Manitoba	Canada
96	Local Institution	Manuels	Newfoundland and Labrador	Canada
97	Local Institution	St. John's	Newfoundland and Labrador	Canada
98	Local Institution	Halifax	Nova Scotia	Canada
99	Local Institution	Markham	Ontario	Canada
100	Local Institution	Oakville	Ontario	Canada
101	Local Institution	Ottawa	Ontario	Canada
102	Local Institution	Thornhill	Ontario	Canada
103	Local Institution	Thunder Bay	Ontario	Canada
104	Local Institution	Toronto	Ontario	Canada
105	Local Institution	Charlottetown	Prince Edward Island	Canada
106	Local Institution	Chicoutimi	Quebec	Canada
107	Local Institution	Drummondville	Quebec	Canada
108	Local Institution	Granby	Quebec	Canada
109	Local Institution	Laval	Quebec	Canada
110	Local Institution	Longueuil	Quebec	Canada
111	Local Institution	Montreal	Quebec	Canada
112	Local Institution	Pointe-Claire	Quebec	Canada
113	Local Institution	St-Lambert	Quebec	Canada
114	Local Institution	Ste-Foy	Quebec	Canada
115	Local Institution	Regina	Saskatchewan	Canada
116	Local Institution	Saskatoon	Saskatchewan	Canada
117	Local Institution	Mexico City	Distrito Federal	Mexico
118	Local Institution	Cuernavaca	Morelos	Mexico
119	Local Institution	Aguascalientes		Mexico
120	Local Institution	Durango		Mexico
121	Local Institution	Krakow		Poland
122	Local Institution	Lodz		Poland
123	Local Institution	Mrokow		Poland
124	Local Institution	Warszawa		Poland
125	Local Institution	Zabrze		Poland
126	Local Institution	Anasco		Puerto Rico
127	Local Institution	Ponce		Puerto Rico
128	Local Institution	Rio Pieoras		Puerto Rico
129	Local Institution	Changhua		Taiwan
130	Local Institution	Taichung		Taiwan

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00246987
• Other Study ID Numbers: CV168-018
• First Posted: Nov 1, 2005
• Last Update Posted: Apr 27, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 27, 2012