Effect of PF-00734200 in Subjects With Type 2 Diabetes

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00618007

Collaborator

(none)

289

Enrollment

Locations

Arms

Duration (Months)

3.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: PF-00734200 30 mg QD Drug: PF-00734200 20 mg QD Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

289 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 30 mg QD	Drug: PF-00734200 30 mg QD 30 mg QD
Experimental: 20 mg QD	Drug: PF-00734200 20 mg QD 20 mg QD
Placebo Comparator: Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: 30 mg QD

Drug: PF-00734200 30 mg QD

30 mg QD

Experimental: 20 mg QD

Drug: PF-00734200 20 mg QD

20 mg QD

Placebo Comparator: Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

HbA1c [12 weeks]

Secondary Outcome Measures

Fasting Glucose [12 weeks]
Fasting Insulin [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women between 18-80 years of age with poorly controlled Type 2 diabetes

Exclusion Criteria:

Type 1 or secondary forms of diabetes Currently using insulin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35205
2	Pfizer Investigational Site	Chandler	Arizona	United States	85225
3	Pfizer Investigational Site	Litchfield Park	Arizona	United States	85340
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85051
5	Pfizer Investigational Site	Artesia	California	United States	90701
6	Pfizer Investigational Site	Cerritos	California	United States	90703
7	Pfizer Investigational Site	Fresno	California	United States	93720
8	Pfizer Investigational Site	Greenbrea	California	United States	94904
9	Pfizer Investigational Site	Huntington Beach	California	United States	92648
10	Pfizer Investigational Site	Los Angeles	California	United States	90057
11	Pfizer Investigational Site	National City	California	United States	91950
12	Pfizer Investigational Site	Roseville	California	United States	95661
13	Pfizer Investigational Site	Valley Village	California	United States	91607
14	Pfizer Investigational Site	West Covina	California	United States	91790
15	Pfizer Investigational Site	DeFuniak Springs	Florida	United States	32435
16	Pfizer Investigational Site	Jacksonville	Florida	United States	32205
17	Pfizer Investigational Site	Miami	Florida	United States	33143
18	Pfizer Investigational Site	Miami	Florida	United States	33169
19	Pfizer Investigational Site	New Port Richey	Florida	United States	34652
20	Pfizer Investigational Site	Ocala	Florida	United States	34471
21	Pfizer Investigational Site	Pinecrest	Florida	United States	33156
22	Pfizer Investigational Site	St. Petersburg	Florida	United States	33702
23	Pfizer Investigational Site	Conyers	Georgia	United States	30094
24	Pfizer Investigational Site	Idaho Falls	Idaho	United States	83404
25	Pfizer Investigational Site	Indianapolis	Indiana	United States	46260
26	Pfizer Investigational Site	Wichita	Kansas	United States	67203
27	Pfizer Investigational Site	Lexington	Kentucky	United States	40504
28	Pfizer Investigational Site	Madisonville	Kentucky	United States	42431
29	Pfizer Investigational Site	Scarborough	Maine	United States	04074
30	Pfizer Investigational Site	Baltimore	Maryland	United States	21204
31	Pfizer Investigational Site	Oxon Hill	Maryland	United States	20745
32	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48106
33	Pfizer Investigational Site	Bay City	Michigan	United States	48706
34	Pfizer Investigational Site	Canton	Michigan	United States	48187
35	Pfizer Investigational Site	Troy	Michigan	United States	48098
36	Pfizer Investigational Site	Jackson	Mississippi	United States	39209
37	Pfizer Investigational Site	Picayune	Mississippi	United States	39466
38	Pfizer Investigational Site	St. Louis	Missouri	United States	63117
39	Pfizer Investigational Site	St. Louis	Missouri	United States	63141
40	Pfizer Investigational Site	St. Peters	Missouri	United States	63376
41	Pfizer Investigational Site	Las Vegas	Nevada	United States	89128
42	Pfizer Investigational Site	Elizabeth	New Jersey	United States	07202
43	Pfizer Investigational Site	Trenton	New Jersey	United States	08611
44	Pfizer Investigational Site	Albuquerque	New Mexico	United States	87106
45	Pfizer Investigational Site	Syracuse	New York	United States	13210
46	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27103
47	Pfizer Investigational Site	Marion	Ohio	United States	43302
48	Pfizer Investigational Site	Eugene	Oregon	United States	97401
49	Pfizer Investigational Site	Cumberland	Rhode Island	United States	02864
50	Pfizer Investigational Site	Aiken	South Carolina	United States	29801
51	Pfizer Investigational Site	Florence	South Carolina	United States	29501
52	Pfizer Investigational Site	Kingsport	Tennessee	United States	37660
53	Pfizer Investigational Site	Dallas	Texas	United States	75230
54	Pfizer Investigational Site	Dallas	Texas	United States	75235
55	Pfizer Investigational Site	El Paso	Texas	United States	79935
56	Pfizer Investigational Site	Houston	Texas	United States	77023
57	Pfizer Investigational Site	Houston	Texas	United States	77081
58	Pfizer Investigational Site	Hurst	Texas	United States	76054
59	Pfizer Investigational Site	Odessa	Texas	United States	79761
60	Pfizer Investigational Site	Pearland	Texas	United States	77584
61	Pfizer Investigational Site	San Antonio	Texas	United States	78229
62	Pfizer Investigational Site	Salt Lake City	Utah	United States	84107
63	Pfizer Investigational Site	Bennington	Vermont	United States	05201-5018
64	Pfizer Investigational Site	Ettrick	Virginia	United States	23803
65	Pfizer Investigational Site	Richmond	Virginia	United States	23225
66	Pfizer Investigational Site	Virginia Beach	Virginia	United States	23454
67	Pfizer Investigational Site	Virginia Beach	Virginia	United States	23455
68	Pfizer Investigational Site	Spokane	Washington	United States	99208
69	Pfizer Investigational Site	Kenosha	Wisconsin	United States	53142
70	Pfizer Investigational Site	Coquitlam	British Columbia	Canada	V3K 3P4
71	Pfizer Investigational Site	Toronto	Ontario	Canada	M9W 4L6
72	Pfizer Investigational Site	Laval	Quebec	Canada	H7T 2P5
73	Pfizer Investigational Site	Pointe-Claire	Quebec	Canada	H9R 4S3
74	Pfizer Investigational Site	Quebec		Canada	G1V 4M6
75	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
76	Pfizer Investigational Site	Seoul		Korea, Republic of	120-752
77	Pfizer Investigational Site	Seoul		Korea, Republic of	135-710
78	Pfizer Investigational Site	Seoul		Korea, Republic of	136-705
79	Pfizer Investigational Site	San Juan		Puerto Rico	00909-1711

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00618007

Other Study ID Numbers:

A7941006

First Posted:

Feb 18, 2008

Last Update Posted:

Jun 27, 2011

Last Verified:

Jun 1, 2011

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 27, 2011