Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00425919
• Collaborator: (none)
• Enrollment: 500
• Locations: 68
• Duration (Months): 9
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: PPM-204	Phase 2

Detailed Description

The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes
• Study Start Date: Jan 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. Fasting Plasma Glucose []

Secondary Outcome Measures

1. Mean changes of HbA1c, Fasting Insulin, HOMA-IR and QUICKI indices, Body weight, waist measurements, total cholesterol, LDL-C, HDL-C, total/HDL, apolipoprotein A-1 & B, triglycerides, free fatty acids, hs C-reactive protein, adiponectin, edema. []

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Men and women of non-childbearing potential, 18 to 70 years old

• Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication

• BMI > 23 and < 43

• For subjects currently treated with 1 antidiabetic medication: HbA1c is greater than or equal to 6.8% and less than or equal to 8.5%.

• For subjects not currently treated with antidiabetic medications: HbA1c is greater than or equal to 7.2% and less than or equal to 9.0%

Exclusion Criteria:

• Subjects requiring insulin therapy

• Subjects currently receiving 2 or more oral antidiabetic medications

• Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit

• Subjects receiving warfarin

• Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit

• Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States	90701
2		Los Angeles	California	United States	90057
3		Chipley	Florida	United States	32428
4		Destin	Florida	United States	32541
5		Marianna	Florida	United States	32446
6		West Palm Beach	Florida	United States	33401
7		Omaha	Nebraska	United States	68131
8		New York	New York	United States	10032
9		Austin	Texas	United States	78705
10		Richmond	Virginia	United States	23249
11		Tacoma	Washington	United States	98405
12		Buenos Aires		Argentina	C1117ABH
13		Corrientes		Argentina	3400
14		La Plata		Argentina	1900
15		Mar del Plata Pcia de Bs. As		Argentina	7600
16		Ramos Mejia, Pcia de Bs.		Argentina	1704
17		Daws Park	South Australia	Australia	5041
18		Keswick	South Australia	Australia	5035
19		Box Hill	Victoria	Australia	3128
20		Vila Clementino - Sao Paulo		Brazil	04020-060
21		Edmonton	Alberta	Canada	T5G 3G6
22		Toronto	Ontario	Canada	M9W 4L6
23		Charlottetown	Prince Edward Island	Canada	C1E 1J7
24		Laval	Quebec	Canada	H7P 2P5
25		Saint-Janvier	Quebec	Canada	J7J 2K8
26		Beijing		China	100730
27		Beijing		China	100853
28		Krapinske Toplice		Croatia	49000
29		Rijeka		Croatia	51000
30		Zagreb		Croatia	10000
31		Belgrade		Former Serbia and Montenegro	11000
32		Athens		Greece	115 21
33		Thessaloniki		Greece	56429
34		Wanchai		Hong Kong
35		Bangalore	Karnataka	India	560043
36		Cochin	Kerala	India	682 026
37		Pune	Maharashtra	India	411001
38		Chennai	Tamil nadu	India	600 013
39		Vellore	Tamil Nadu	India	632004
40		Catanzaro		Italy	88100
41		Pisa		Italy	56124
42		Aguascalientes		Mexico	20230
43		Mexico D.F.		Mexico	11650
44		Mexico DF		Mexico	14000
45		Miguel Hidalgo		Mexico	11550
46		Monterrey N.L		Mexico	64410
47		Tlapan		Mexico	14080
48		Bucuresti		Romania	10825
49		Bucuresti		Romania	20475
50		Cluj-Napoca		Romania	400006
51		Moscow		Russian Federation	117036
52		Moscow		Russian Federation	117292
53		Moscow		Russian Federation	123154
54		Moscow		Russian Federation	125315
55		St. Petersburg		Russian Federation	194044
56		St. Petersburg		Russian Federation	194354
57		Port Elizabeth	Eastern Cape	South Africa	6014
58		Benoni	Gauteng	South Africa	1501
59		Pretoria	Gauteng	South Africa	0002
60		Pretoria	Gauteng	South Africa	39
61		Temba	North West Province	South Africa	400
62		Kharkiv		Ukraine	61070
63		Kyiv		Ukraine	02175
64		Poltava		Ukraine	36024
65		Uzhgorod		Ukraine	80312
66		Dundee		United Kingdom	DD1 9SY
67		Edinburgh		United Kingdom	EH4 2XU
68		Livingston		United Kingdom	EH54 6PP

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
• Principal Investigator: Trial Manager, For Argentina, [e-mail]
• Principal Investigator: Trial Manager, For Australia, [e-mail]
• Principal Investigator: Trial Manager, For Brazil, [e-mail]
• Principal Investigator: Trial Manager, For Austria, [e-mail]
• Principal Investigator: Trial Manager, For Canada, [e-mail]
• Principal Investigator: Trial Manager, For Chile, [e-mail]
• Principal Investigator: Trial Manager, For China, [e-mail]
• Principal Investigator: Trial Manager, For Croatia, [e-mail]
• Principal Investigator: Trial Manager, For Greece, [e-mail]
• Principal Investigator: Trial Manager, For Hong Kong, [e-mail]
• Principal Investigator: Trial Manager, For Italy, [e-mail]
• Principal Investigator: Trial Manager, For Mexico, [e-mail]
• Principal Investigator: Trial Manager, For Romania, [e-mail]
• Principal Investigator: Trial Manager, For Russia, [e-mail]
• Principal Investigator: Trial Manager, For Serbia, [e-mail]
• Principal Investigator: Trial Manager, For South Africa, [e-mail]
• Principal Investigator: Trial Manager, For UK/Great Britian, [e-mail]
• Principal Investigator: Trial Manager, For Ukraine, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00425919
• Other Study ID Numbers: 3180A1-200
• First Posted: Jan 23, 2007
• Last Update Posted: Dec 27, 2007
• Last Verified: Dec 1, 2007

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

Study Results

No Results Posted as of Dec 27, 2007