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A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00391196
Collaborator
(none)
975
Enrollment
91
Locations
3
Arms
26
Duration (Months)
10.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Study Design

Study Type:
Interventional
Actual Enrollment :
975 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
Subjects receive placebo plus non-pharmacological weight loss program.
Experimental: CP-945,598

Drug: CP-945,598
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Experimental: CP-945,598 Treatment B

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Drug: CP-945,598 Treatment B
Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Outcome Measures

Primary Outcome Measures

  1. Percent change in body weight from baseline. [1 year]

Secondary Outcome Measures

  1. Proportion of subjects who lose 5 and 10% baseline body weight at 1 year; [1 year]

  2. Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year; [1 year]

  3. Change from baseline in waist circumference at 1 year; [1 year]

  4. Change from baseline fasting triglyceride and HDL concentrations at 1 year; [1 year]

  5. Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year; [1 year]

  6. Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion; [1 year]

  7. HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year; [1 year]

  8. Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control; [1 year]

  9. Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships; [1 year]

  10. Change from baseline fasting plasma glucose concentration at 1 year; [1 year]

  11. Change from baseline in Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7 scores at months 1, 2, 3, 5, 6, 9, and 1 year; [1 year]

  12. Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications; [1 year]

  13. Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year; [1 year]

  14. Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11; [1 year]

  15. HbA1c, fasting plasma glucose at months 1, 3, 6, and 9; [1 year]

  16. Waist circumference at months 3, 6, and 9; [1 year]

  17. Fasting triglyceride and HDL concentrations at month 6 and patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at months 3 and 6; [1 year]

  18. Change from baseline in laboratory tests and ECGs at 1 year; vitals signs at (at Week 2, Months 1 - 6, 9, 11 and 1 year) and adverse events; [1 year]

  19. Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year; [1 year]

  20. Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events; [1 year]

  21. Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year; [1 year]

  22. Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year; [1 year]

  23. Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12 [1 year]

  24. Change from baseline HbA1c to 1 year; [1 year]

Eligibility Criteria

Criteria

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

  • Subjects must be overweight (BMI 27- 50 kg/m2)

  • Subjects must have type 2 diabetes mellitus

Exclusion Criteria:

  • Pregnancy

  • Serious or unstable current or past medical conditions

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States 35233
2 Pfizer Investigational Site Birmingham Alabama United States 35294
3 Pfizer Investigational Site Huntsville Alabama United States 35801
4 Pfizer Investigational Site Mobile Alabama United States 36608
5 Pfizer Investigational Site Chandler Arizona United States 85224
6 Pfizer Investigational Site Mesa Arizona United States 85213
7 Pfizer Investigational Site Phoenix Arizona United States 85014
8 Pfizer Investigational Site Fresno California United States 93720
9 Pfizer Investigational Site Palm Springs California United States 92262
10 Pfizer Investigational Site Tustin California United States 92780
11 Pfizer Investigational Site Walnut Creek California United States 94598
12 Pfizer Investigational Site New Britain Connecticut United States 06050
13 Pfizer Investigational Site Washington District of Columbia United States 20003-4393
14 Pfizer Investigational Site Orlando Florida United States 32809
15 Pfizer Investigational Site West Palm Beach Florida United States 33401
16 Pfizer Investigational Site Honolulu Hawaii United States 96814
17 Pfizer Investigational Site Gurnee Illinois United States 60031
18 Pfizer Investigational Site Madisonville Kentucky United States 42431
19 Pfizer Investigational Site Baton Rouge Louisiana United States 70808
20 Pfizer Investigational Site Metairie Louisiana United States 70002
21 Pfizer Investigational Site Auburn Maine United States 04210
22 Pfizer Investigational Site Scarborough Maine United States 04074
23 Pfizer Investigational Site Baltimore Maryland United States 21204
24 Pfizer Investigational Site Bay City Michigan United States 48706
25 Pfizer Investigational Site Troy Michigan United States 48098
26 Pfizer Investigational Site Edina Minnesota United States 55435
27 Pfizer Investigational Site Jefferson City Missouri United States 65109
28 Pfizer Investigational Site Albuquerque New Mexico United States 87108
29 Pfizer Investigational Site Buffalo New York United States 14209
30 Pfizer Investigational Site New York New York United States 10025
31 Pfizer Investigational Site Greenville North Carolina United States 27834
32 Pfizer Investigational Site Beaver Pennsylvania United States 15009
33 Pfizer Investigational Site Cumberland Rhode Island United States 02864
34 Pfizer Investigational Site Pawtucket Rhode Island United States 02860
35 Pfizer Investigational Site Greer South Carolina United States 29651
36 Pfizer Investigational Site Bristol Tennessee United States 37620
37 Pfizer Investigational Site Nashville Tennessee United States 37203
38 Pfizer Investigational Site Dallas Texas United States 75230
39 Pfizer Investigational Site Dallas Texas United States 75246
40 Pfizer Investigational Site San Antonio Texas United States 78229
41 Pfizer Investigational Site San Antonio Texas United States 78237
42 Pfizer Investigational Site Renton Washington United States 98057
43 Pfizer Investigational Site Morgantown West Virginia United States 26506-9136
44 Pfizer Investigational Site Buenos Aires Argentina C1034ACO
45 Pfizer Investigational Site Buenos Aires Argentina C1405CWB
46 Pfizer Investigational Site Buenos Aires Argentina C1426ABP
47 Pfizer Investigational Site Garran Australian Capital Territory Australia 2605
48 Pfizer Investigational Site Wollongong New South Wales Australia 2500
49 Pfizer Investigational Site Adelaide South Australia Australia 5000
50 Pfizer Investigational Site Box Hill Victoria Australia 3128
51 Pfizer Investigational Site Nedlands Western Australia Australia 6009
52 Pfizer Investigational Site Curitiba PR Brazil 80030-110
53 Pfizer Investigational Site Porto Alegre RS Brazil 90035-170
54 Pfizer Investigational Site São Paulo SP Brazil 01221-020
55 Pfizer Investigational Site São Paulo SP Brazil 01244-030
56 Pfizer Investigational Site São Paulo SP Brazil 04025-011
57 Pfizer Investigational Site São Paulo SP Brazil 05403-000
58 Pfizer Investigational Site Red Deer Alberta Canada T4N 6V7
59 Pfizer Investigational Site Coquitlam British Columbia Canada V3K 3P4
60 Pfizer Investigational Site Winnipeg Manitoba Canada R3E 3P4
61 Pfizer Investigational Site Thornhill Ontario Canada L4J 8L7
62 Pfizer Investigational Site Charlottetown Prince Edward Island Canada C1E 1J7
63 Pfizer Investigational Site L'Ancienne-Lorette Quebec Canada G2E 2X1
64 Pfizer Investigational Site Saint-Marc-des-Carrières Quebec Canada G0A 4B0
65 Pfizer Investigational Site Breclav Czech Republic 690 02
66 Pfizer Investigational Site Ceske Budejovice Czech Republic 370 87
67 Pfizer Investigational Site Olomouc Czech Republic 772 00
68 Pfizer Investigational Site Praha 2 Czech Republic 128 08
69 Pfizer Investigational Site Praha 4 - Krc Czech Republic 140 21
70 Pfizer Investigational Site Berlin Germany 13125
71 Pfizer Investigational Site Dresden Germany 01219
72 Pfizer Investigational Site Duesseldorf Germany 40225
73 Pfizer Investigational Site Hamburg Germany 20253
74 Pfizer Investigational Site Leipzig Germany 04103
75 Pfizer Investigational Site Mittweida Germany 09648
76 Pfizer Investigational Site Tampico Cd. Madero Mexico 89109
77 Pfizer Investigational Site Mexico DF Mexico 11850
78 Pfizer Investigational Site Guadalajara Jalisco Mexico 44340
79 Pfizer Investigational Site Monterrey Nuevo León Mexico 64460
80 Pfizer Investigational Site Banska Bystrica Slovakia 975 17
81 Pfizer Investigational Site Bratislava Slovakia 813 69
82 Pfizer Investigational Site Lubochna Slovakia 034 91
83 Pfizer Investigational Site Nitra Slovakia 950 01
84 Pfizer Investigational Site Goteborg Sweden 413 45
85 Pfizer Investigational Site Huddinge Sweden 141 86
86 Pfizer Investigational Site Edinburgh Lothian United Kingdom EH4 2XU
87 Pfizer Investigational Site Bath Somerset United Kingdom BA1 3NG
88 Pfizer Investigational Site Coventry United Kingdom CV2 2DX
89 Pfizer Investigational Site Dumfries United Kingdom DG1 4AP
90 Pfizer Investigational Site Dundee United Kingdom DD1 9SY
91 Pfizer Investigational Site Luton United Kingdom LU4 0DZ

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00391196
Other Study ID Numbers:
  • A5351022
First Posted:
Oct 23, 2006
Last Update Posted:
Nov 7, 2012
Last Verified:
Nov 1, 2012
Additional relevant MeSH terms:
Obesity
Overweight

Study Results

No Results Posted as of Nov 7, 2012