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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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00391196
First received: October 19, 2006
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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 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.

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

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00391196     History of Changes
Other Study ID Numbers: A5351022
Study First Received: October 19, 2006
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013