A Study to Evaluate Combining Metformin With Muraglitazar or Pioglitazone in Type 2 Diabetics

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00240370
• Collaborator: (none)
• Enrollment: 1,159
• Locations: 85
• Patients Per Site: 13.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate if type 2 diabetics who have inadequate glycemic control on metformin alone, have a similar, or not inferior, glycemic response when treated with the combination of muraglitazar and metformin compared to pioglitazone and metformin.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	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, Active-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Compared to Pioglitazone in Combination With Metformin in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. Compare change from basline in HbA1c after 24 weeks and 50 weeks of treatment with muraglitazar + metformin vs. pioglitazone + metformin []

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 []

2. 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 diabetics

• HbA1c ≥7.0% and ≤10.0%,currently receiving a stable dose of metformin 1500 to 2550 mg/day for at least 6 weeks prior to screening were enrolled in this study.

• Fasting C-peptide ≥1.0 ng/mL

• BMI≤41 kg/m2 mean fasting serum trig. ≤600 g/dL

Exclusion Criteria:

• symptomatic type 2 diabetics with > 10% weight loss 3 months prior to study

• history of diabetic ketoacidosis, hyperosmolar nonketotic coma, insulin therapy, inability to take muraglitazar, pioglitazone, or metformin according to investigator brochure or labeling

• 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 of, 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	Birmingham	Alabama	United States
2	Local Institution	Columbiana	Alabama	United States
3	Local Institution	Mesa	Arizona	United States
4	Local Institution	Peoria	Arizona	United States
5	Local Institution	Carlisle	Arkansas	United States
6	Local Institution	Jonesboro	Arkansas	United States
7	Local Institution	Little Rock	Arkansas	United States
8	Local Institution	Pine Bluff	Arkansas	United States
9	Local Institution	Sherwood	Arkansas	United States
10	Local Institution	Anaheim	California	United States
11	Local Institution	Artesia	California	United States
12	Local Institution	Encino	California	United States
13	Local Institution	Encintas	California	United States
14	Local Institution	Fresno	California	United States
15	Local Institution	Long Beach	California	United States
16	Local Institution	Los Angeles	California	United States
17	Local Institution	Northridge	California	United States
18	Local Institution	Denver	Colorado	United States
19	Local Institution	Hamden	Connecticut	United States
20	Local Institution	Altamonte Springs	Florida	United States
21	Local Institution	Hollywood	Florida	United States
22	Local Institution	Jacksonville	Florida	United States
23	Local Institution	Miami	Florida	United States
24	Local Institution	New Port Richie	Florida	United States
25	Local Institution	St. Cloud	Florida	United States
26	Local Institution	W Palm Beach	Florida	United States
27	Local Institution	Honolulu	Hawaii	United States
28	Local Institution	Evansville	Indiana	United States
29	Local Institution	Lafayette	Indiana	United States
30	Local Institution	New Orleans	Louisiana	United States
31	Local Institution	Shreveport	Louisiana	United States
32	Local Institution	Baltimore	Maryland	United States
33	Local Institution	Detroit	Michigan	United States
34	Local Institution	Gulfport	Mississippi	United States
35	Local Institution	St. Louis	Missouri	United States
36	Local Institution	Omaha	Nebraska	United States
37	Local Institution	Endwell	New York	United States
38	Local Institution	Cary	North Carolina	United States
39	Local Institution	Charlotte	North Carolina	United States
40	Local Institution	Morehead	North Carolina	United States
41	Local Institution	Raleigh	North Carolina	United States
42	Local Institution	Statesville	North Carolina	United States
43	Local Institution	Wilmington	North Carolina	United States
44	Local Institution	Winston-Salem	North Carolina	United States
45	Local Institution	Bellbrook	Ohio	United States
46	Local Institution	Maumee	Ohio	United States
47	Local Institution	Thornville	Ohio	United States
48	Local Institution	Oklahoma City	Oklahoma	United States
49	Local Institution	Portland	Oregon	United States
50	Local Institution	Camp Hill	Pennsylvania	United States
51	Local Institution	Melrose Park	Pennsylvania	United States
52	Local Institution	Pittsburgh	Pennsylvania	United States
53	Local Institution	West Chester	Pennsylvania	United States
54	Local Institution	Youngwood	Pennsylvania	United States
55	Local Institution	East Providence	Rhode Island	United States
56	Local Institution	Charleston	South Carolina	United States
57	Local Institution	Clinton	South Carolina	United States
58	Local Institution	Memphis	Tennessee	United States
59	Local Institution	Austin	Texas	United States
60	Local Institution	Carrollton	Texas	United States
61	Local Institution	Corpus Christi	Texas	United States
62	Local Institution	Dallas	Texas	United States
63	Local Institution	Houston	Texas	United States
64	Local Institution	Midland	Texas	United States
65	Local Institution	San Antonio	Texas	United States
66	Local Institution	Salt Lake City	Utah	United States
67	Local Institution	Lebanon	Virginia	United States
68	Local Institution	Spokane	Washington	United States
69	Local Institution	Tacoma	Washington	United States
70	Local Institution	Bluefield	West Virginia	United States
71	Local Institution	Red Deer	Alberta	Canada
72	Local Institution	Vancouver	British Columbia	Canada
73	Local Institution	Sarnia	Ontario	Canada
74	Local Institution	Bonaventure	Quebec	Canada
75	Local Institution	Drummondville	Quebec	Canada
76	Local Institution	Montreal	Quebec	Canada
77	Local Institution	Rimouski	Quebec	Canada
78	Local Institution	Tijuana	Baja California	Mexico
79	Local Institution	Mexico City	Distrito Federal	Mexico
80	Local Institution	Mexico	Durango	Mexico
81	Local Institution	Cuernavaca	Morelos	Mexico
82	Local Institution	Aguascalientes		Mexico
83	Local Institution	Chihuahua		Mexico
84	Local Institution	Aguas Buenas		Puerto Rico
85	Local Institution	Ponce		Puerto Rico

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00240370
• Other Study ID Numbers: CV168-025
• First Posted: Oct 18, 2005
• Last Update Posted: Sep 14, 2010
• Last Verified: Jun 1, 2008

Study Results

No Results Posted as of Sep 14, 2010