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

Tracking Information

First Received Date ^ICMJE

October 19, 2006

Last Updated Date

October 27, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent change in body weight from baseline. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in body weight over one year.

Change History

Complete list of historical versions of study NCT00391196 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects who lose 5 and 10% baseline body weight at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in waist circumference at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline fasting triglyceride and HDL concentrations at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline fasting plasma glucose concentration at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Waist circumference at months 3, 6, and 9; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline HbA1c to 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

HbA1c, BP, blood lipids, fasting glucose, waist circumference, quality of life over 1 year.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: Placebo
Drug: CP-945,598
Drug: CP-945,598 Treatment B

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

975

Completion Date

January 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Canada, Czech Republic, Germany, Mexico, Slovakia, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00391196

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A5351022

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP