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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00391196

Purpose

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	Intervention	Phase
Obesity	Drug: Placebo Drug: CP-945,598 Drug: CP-945,598 Treatment B	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia Diabetes Obesity

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	975
Study Start Date:	November 2006
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Subjects receive placebo plus non-pharmacological weight loss program.
CP-945,598: Experimental	Drug: CP-945,598 Subjects receive CP-945,598 plus non-pharmacological weight loss program.
CP-945,598 Treatment B: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391196

Show 91 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351022
Study First Received:	October 19, 2006
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00391196 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009