A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00542009
First received: October 5, 2007
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes


Condition Intervention Phase
Weight Management
Treatment Of Obesity
Drug: CE-326,597 100 mg QD
Drug: CE-326,597 50 mg QD
Drug: CE-326,597 25 mg QD
Drug: Placebo
Drug: CE-326,597 5mg QD
Phase 2

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 12-Week, Phase 2A, Randomized, Subject And Investigator Blinded, Placebo-Controlled Trial To Evaluate The Safety, Tolerability And Efficacy Of CE-326,597 On Glucose Control And Body Weight In Overweight Adult Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Glucose control [ Time Frame: At Day 84 ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: At Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regimen (dose or number) of anti-diabetic agents [ Time Frame: At Day 84 ] [ Designated as safety issue: No ]
  • GlycoMark [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HbA1C <7% and <6.5% [ Time Frame: On Day 84 ] [ Designated as safety issue: No ]
  • Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial. [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
  • Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial. [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Change in following parameters: Post-prandial and fasting glucose, and insulin [ Time Frame: On Day 28 ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CE-326,597 100 mg QD Drug: CE-326,597 100 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
Experimental: CE-326,597 50 mg QD Drug: CE-326,597 50 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
Experimental: CE-326,597 25 mg QD Drug: CE-326,597 25 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
Placebo Comparator: Placebo Drug: Placebo
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
Experimental: CE-326,597 5mg QD Drug: CE-326,597 5mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.

Exclusion Criteria:

Women of childbearing potential, people with unstable medical conditions, people with gallstones

  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: NCT00542009

  Show 54 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: NCT00542009     History of Changes
Other Study ID Numbers: A7211005
Study First Received: October 5, 2007
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014