NCT00542009

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Weight Management
• Treatment Of Obesity

Interventions

Type	Name	Description
DRUG	CE-326,597 100 mg QD	Administered orally, once daily with morning meal for duration of trial (84 days).
DRUG	CE-326,597 50 mg QD	Administered orally, once daily with morning meal for duration of trial (84 days).
DRUG	CE-326,597 25 mg QD	Administered orally, once daily with morning meal for duration of trial (84 days).
DRUG	Placebo	Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
DRUG	CE-326,597 5mg QD	Administered orally, once daily with morning meal for duration of trial (84 days).

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-10-10
• Last updated: 2012-11-07

Locations

54 sites across 7 countries: United States, Bulgaria, Canada, India, Mexico, Puerto Rico, Spain