12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00473525

Collaborator

(none)

303

Enrollment

Locations

Arms

Duration (Months)

3.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Placebo Drug: PF-00734200 10 mg QD Drug: PF-00734200 20 mg QD Drug: PF-00734200 5 mg QD Drug: PF-00734200 2 mg QD	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

303 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo QD
Experimental: PF-00734200 10 mg QD	Drug: PF-00734200 10 mg QD 10 mg QD
Experimental: PF-00734200 20 mg QD	Drug: PF-00734200 20 mg QD 20 mg QD
Experimental: PF-00734200 5 mg QD	Drug: PF-00734200 5 mg QD 5 mg QD
Experimental: PF-00734200 2 mg QD	Drug: PF-00734200 2 mg QD 2 mg QD

Outcome Measures

Primary Outcome Measures

HbA1C levels (%) [12 weeks]
Evaluation of Dose Response in HbA1c (%) [12 weeks]

Secondary Outcome Measures

Insulin and Glucose AUC following a mixed meal tolerance test [12 weeks]
Proportion of subjects achieving ADA glycemic goal of Hb A1c <7% [12 weeks]
Incidence of Adverse Events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of type 2 diabetes
Hb1AC >7%-11% inclusive
Male and females 18-70; females must be post-menopausal
On a stable dose of metformin hydrochloride

Exclusion Criteria:

Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
Women of childbearing potential, pregnant or nursing
Evidence of diabetic complications with significant end-organ damage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35209
2	Pfizer Investigational Site	Gilbert	Arizona	United States	85296
3	Pfizer Investigational Site	Phoenix	Arizona	United States	85013
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85016
5	Pfizer Investigational Site	Jonesboro	Arkansas	United States	72401
6	Pfizer Investigational Site	Little Rock	Arkansas	United States	72205-6217
7	Pfizer Investigational Site	Carmichael	California	United States	95608
8	Pfizer Investigational Site	Chula Vista	California	United States	91911
9	Pfizer Investigational Site	Fair Oaks	California	United States	95628
10	Pfizer Investigational Site	Los Angeles	California	United States	90057
11	Pfizer Investigational Site	National City	California	United States	91950
12	Pfizer Investigational Site	Paramount	California	United States	90273
13	Pfizer Investigational Site	Roseville	California	United States	95661
14	Pfizer Investigational Site	Sacramento	California	United States	95825
15	Pfizer Investigational Site	DeFuniak Springs	Florida	United States	32435
16	Pfizer Investigational Site	Destin	Florida	United States	32541
17	Pfizer Investigational Site	Jacksonville	Florida	United States	32216
18	Pfizer Investigational Site	New Port Richey	Florida	United States	34652
19	Pfizer Investigational Site	New Port Richey	Florida	United States	34653
20	Pfizer Investigational Site	Palm Harbor	Florida	United States	34684
21	Pfizer Investigational Site	West Palm Beach	Florida	United States	33401
22	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
23	Pfizer Investigational Site	Conyers	Georgia	United States	30094
24	Pfizer Investigational Site	Chicago	Illinois	United States	60607
25	Pfizer Investigational Site	Skokie	Illinois	United States	60076
26	Pfizer Investigational Site	Skokie	Illinois	United States	60077
27	Pfizer Investigational Site	Wheeling	Illinois	United States	60090
28	Pfizer Investigational Site	Lexington	Kentucky	United States	40503
29	Pfizer Investigational Site	Lexington	Kentucky	United States	40504
30	Pfizer Investigational Site	Brockton	Massachusetts	United States	02301
31	Pfizer Investigational Site	Worcester	Massachusetts	United States	01602
32	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48106
33	Pfizer Investigational Site	Canton	Michigan	United States	48187
34	Pfizer Investigational Site	Flint	Michigan	United States	48532
35	Pfizer Investigational Site	Biloxi	Mississippi	United States	39531
36	Pfizer Investigational Site	Picayune	Mississippi	United States	39466
37	Pfizer Investigational Site	St. Louis	Missouri	United States	63141
38	Pfizer Investigational Site	Omaha	Nebraska	United States	68114
39	Pfizer Investigational Site	Las Vegas	Nevada	United States	89119
40	Pfizer Investigational Site	Las Vegas	Nevada	United States	89128
41	Pfizer Investigational Site	Las Vegas	Nevada	United States	89148
42	Pfizer Investigational Site	Trenton	New Jersey	United States	08611
43	Pfizer Investigational Site	Cary	North Carolina	United States	27518
44	Pfizer Investigational Site	Raleigh	North Carolina	United States	27609
45	Pfizer Investigational Site	Raleigh	North Carolina	United States	27612
46	Pfizer Investigational Site	Marion	Ohio	United States	43302
47	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73103
48	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73119
49	Pfizer Investigational Site	Carnegie	Pennsylvania	United States	15106
50	Pfizer Investigational Site	East Providence	Rhode Island	United States	02914
51	Pfizer Investigational Site	Bartlett	Tennessee	United States	38134
52	Pfizer Investigational Site	Collierville	Tennessee	United States	38017
53	Pfizer Investigational Site	Kingsport	Tennessee	United States	37660
54	Pfizer Investigational Site	Dallas	Texas	United States	75230
55	Pfizer Investigational Site	Houston	Texas	United States	77023
56	Pfizer Investigational Site	Houston	Texas	United States	77074
57	Pfizer Investigational Site	Houston	Texas	United States	77079
58	Pfizer Investigational Site	Houston	Texas	United States	77081
59	Pfizer Investigational Site	Irving	Texas	United States	75039
60	Pfizer Investigational Site	San Antonio	Texas	United States	78229
61	Pfizer Investigational Site	San Antonio	Texas	United States	78237
62	Pfizer Investigational Site	Richmond	Virginia	United States	23225
63	Pfizer Investigational Site	Virginia Beach	Virginia	United States	23455
64	Pfizer Investigational Site	Milwaukee	Wisconsin	United States	53209
65	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	0
66	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
67	Pfizer Investigational Site	Floridablanca	Santander	Colombia	0
68	Pfizer Investigational Site	Berlin		Germany	10787
69	Pfizer Investigational Site	Giengen		Germany	89537
70	Pfizer Investigational Site	Hamburg		Germany	21073
71	Pfizer Investigational Site	Muenchen		Germany	81241
72	Pfizer Investigational Site	Roma		Italy	00161
73	Pfizer Investigational Site	Santiago de Compostela	La Coruña	Spain	15706
74	Pfizer Investigational Site	Alcala de Henares	Madrid	Spain	28805
75	Pfizer Investigational Site	Valencia		Spain	46009
76	Pfizer Investigational Site	Valencia		Spain	46014
77	Pfizer Investigational Site	Goteborg		Sweden	41665
78	Pfizer Investigational Site	Malmo		Sweden	21136
79	Pfizer Investigational Site	Stockholm		Sweden	111 57

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:

NCT00473525

Other Study ID Numbers:

A7941005

First Posted:

May 15, 2007

Last Update Posted:

Jun 24, 2010

Last Verified:

Jun 1, 2010

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 24, 2010