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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Overweight
Obesity
Body Weight
Signs and Symptoms
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014