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
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
Diabetes Mellitus, Type 2
Obesity
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on April 23, 2014