PPAR-COMBO With Sulfonylurea

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00162175
• Collaborator: (none)
• Enrollment: 534
• Locations: 150
• Duration (Months): 28.1
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

Condition or Disease	Intervention/Treatment	Phase
Metabolics Diabetes Nos	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 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone
• Study Start Date: Jul 1, 2003
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide []

Secondary Outcome Measures

1. Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24 []

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Type 2 Diabetes, HbA1c > 7.0% and < 10.0%, mean serum triglyceride < 600 mg/dL, body mass index < 41 kg/m2, fasting c-peptide . 1.5 ng/mL.

Exclusion Criteria:

• History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or 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	Hoover	Alabama	United States
3	Local Institution	Huntsville	Alabama	United States
4	Local Institution	Mobile	Alabama	United States
5	Local Institution	Mesa	Arizona	United States
6	Local Institution	Phoenix	Arizona	United States
7	Local Institution	Tucson	Arizona	United States
8	Local Institution	Little Rock	Arkansas	United States
9	Local Institution	Encinitas	California	United States
10	Local Institution	Long Beach	California	United States
11	Local Institution	Los Angeles	California	United States
12	Local Institution	Mission Viejo	California	United States
13	Local Institution	Pasadena	California	United States
14	Local Institution	San Diego	California	United States
15	Local Institution	Walnut Creek	California	United States
16	Local Institution	Westlake Village	California	United States
17	Local Institution	Colorado Springs	Colorado	United States
18	Local Institution	Denver	Colorado	United States
19	Local Institution	Loveland	Colorado	United States
20	Local Institution	Wheat Ridge	Colorado	United States
21	Local Institution	Chipley	Florida	United States
22	Local Institution	Miami	Florida	United States
23	Local Institution	New Port Richey	Florida	United States
24	Local Institution	Pinellas Park	Florida	United States
25	Local Institution	Vero Beach	Florida	United States
26	Local Institution	Winter Park	Florida	United States
27	Local Institution	Dunwoody	Georgia	United States
28	Local Institution	Chicago	Illinois	United States
29	Local Institution	Overland Park	Kansas	United States
30	Local Institution	Lexington	Kentucky	United States
31	Local Institution	Slidell	Louisiana	United States
32	Local Institution	Chester	Maryland	United States
33	Local Institution	Silver Springs	Maryland	United States
34	Local Institution	Springfield	Massachusetts	United States
35	Local Institution	Berkley	Michigan	United States
36	Local Institution	Detroit	Michigan	United States
37	Local Institution	Arden Hills	Minnesota	United States
38	Local Institution	Gulfport	Mississippi	United States
39	Local Institution	Excelsior Springs	Missouri	United States
40	Local Institution	Kansas City	Missouri	United States
41	Local Institution	St. Louis	Missouri	United States
42	Local Institution	East Syracuse	New York	United States
43	Local Institution	Charlotte	North Carolina	United States
44	Local Institution	Greensboro	North Carolina	United States
45	Local Institution	Hickory	North Carolina	United States
46	Local Institution	Huntersville	North Carolina	United States
47	Local Institution	Morehead City	North Carolina	United States
48	Local Institution	Wilmington	North Carolina	United States
49	Local Institution	Cincinnati	Ohio	United States
50	Local Institution	Oklahoma City	Oklahoma	United States
51	Local Institution	Tulsa	Oklahoma	United States
52	Local Institution	Corvallis	Oregon	United States
53	Local Institution	Eugene	Oregon	United States
54	Local Institution	Portland	Oregon	United States
55	Local Institution	Altoona	Pennsylvania	United States
56	Local Institution	Philadelphia	Pennsylvania	United States
57	Local Institution	Cranston	Rhode Island	United States
58	Local Institution	Anderson	South Carolina	United States
59	Local Institution	Duncan	South Carolina	United States
60	Local Institution	Simpsonville	South Carolina	United States
61	Local Institution	Summerville	South Carolina	United States
62	Local Institution	Bristol	Tennessee	United States
63	Local Institution	Kingsport	Tennessee	United States
64	Local Institution	Knoxville	Tennessee	United States
65	Local Institution	Memphis	Tennessee	United States
66	Local Institution	Dallas	Texas	United States
67	Local Institution	Houston	Texas	United States
68	Local Institution	Irving	Texas	United States
69	Local Institution	Lake Jackson	Texas	United States
70	Local Institution	San Antonio	Texas	United States
71	Local Institution	The Colony	Texas	United States
72	Local Institution	Olympia	Washington	United States
73	Local Institution	Bluefield	West Virginia	United States
74	Local Institution	Marshfield	Wisconsin	United States
75	Local Institution	Bahia Blanca	Buenas Aires	Argentina
76	Local Institution	Capital Federal	Buenos Aires	Argentina
77	Local Institution	Buenos Aires		Argentina
78	Local Institution	Cordoba		Argentina
79	Local Institution	Mendoza		Argentina
80	Local Institution	Canberra	New South Wales	Australia
81	Local Institution	Wollongong	New South Wales	Australia
82	Local Institution	Brisbane	Queensland	Australia
83	Local Institution	Curitiba	Parana	Brazil
84	Local Institution	Belem	Para	Brazil
85	Local Institution	Porto Alegre	Rio Grande Do Sul	Brazil
86	Local Institution	Marilia	Sao Paulo	Brazil
87	Local Institution	Corunna	Ontario	Canada
88	Local Institution	Hawksbury	Ontario	Canada
89	Local Institution	Sarnia	Ontario	Canada
90	Local Institution	Gatineau	Quebec	Canada
91	Local Institution	Laval	Quebec	Canada
92	Local Institution	St. Jerome	Quebec	Canada
93	Local Institution	St. John's		Canada
94	Local Institution	Rosiers	D'Egletons	France
95	Local Institution	Labarthe	Sur Leze	France
96	Local Institution	Husseren	Wesserling	France
97	Local Institution	Broglie		France
98	Local Institution	Chartres		France
99	Local Institution	Gemenos		France
100	Local Institution	Viernheim	Schwenningen	Germany
101	Local Institution	Dresden		Germany
102	Local Institution	Hamburg		Germany
103	Local Institution	Nuernberg		Germany
104	Local Institution	Ravenna		Italy
105	Local Institution	Tijuana	Baja California	Mexico
106	Local Institution	Mexico	Distrito Federal	Mexico
107	Local Institution	Leon	Guanajuato	Mexico
108	Local Institution	Albuquerque	New Mexico	Mexico
109	Local Institution	Monterrey	Nuevo Leon	Mexico
110	Local Institution	Merida	Yucatan	Mexico
111	Local Institution	Durango		Mexico
112	Local Institution	Deurne		Netherlands
113	Local Institution	Ewyk		Netherlands
114	Local Institution	Hoogvliet		Netherlands
115	Local Institution	Rijswijk		Netherlands
116	Local Institution	S Gravenhage		Netherlands
117	Local Institution	Zwijndrecht		Netherlands
118	Local Institution	Arequipa		Peru
119	Local Institution	Lima		Peru
120	Local Institution	Carolina		Puerto Rico
121	Local Institution	Guaynabo		Puerto Rico
122	Local Institution	Ponce		Puerto Rico
123	Local Institution	Rio Piedras		Puerto Rico
124	Local Institution	Moscow		Russian Federation
125	Local Institution	Saratov		Russian Federation
126	Local Institution	Smolensk		Russian Federation
127	Local Institution	St. Petersburg		Russian Federation
128	Local Institution	Santiago	de Compostela	Spain
129	Local Institution	Las Palmas	DE	Spain
130	Local Institution	A Coruna		Spain
131	Local Institution	Alicante		Spain
132	Local Institution	Cadiz		Spain
133	Local Institution	Granada		Spain
134	Local Institution	La Coruna		Spain
135	Local Institution	Madrid		Spain
136	Local Institution	Oviedo		Spain
137	Local Institution	Tenerife		Spain
138	Local Institution	Teruel		Spain
139	Local Institution	Zaragoza		Spain
140	Local Institution	Soham	Cambridgeshire	United Kingdom
141	Local Institution	Bexhill-on-Sea	East Sussex	United Kingdom
142	Local Institution	Sunbury on Thames	Greater London	United Kingdom
143	Local Institution	Aldershot	Hampshire	United Kingdom
144	Local Institution	Glasgow	Lanarkshire	United Kingdom
145	Local Institution	Blackpool	Lancashire	United Kingdom
146	Local Institution	Harrow	Middlesex	United Kingdom
147	Local Institution	Hastings	Sussex	United Kingdom
148	Local Institution	Bath	Wiltshire	United Kingdom
149	Local Institution	Inkberrow	Worcestershire	United Kingdom
150	Local Institution	Swan Lane		United Kingdom

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162175
• Other Study ID Numbers: CV168-021
• First Posted: Sep 13, 2005
• Last Update Posted: Sep 14, 2010
• Last Verified: Sep 1, 2007

• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Sep 14, 2010