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

Phase 2

Completed

• Conditions: Weight Management; Treatment Of Obesity
• Interventions: 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

• Registration Number: NCT00542009
• Lead Sponsor: Pfizer

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Study Start: 2007-12
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Disposition First Submitted: 2009-08-12
• Disposition First Submitted QC: 2009-08-12
• Disposition First Posted: 2009-08-13
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CE-326,597 100 mg QD	CE-326,597 100 mg QD	-
CE-326,597 50 mg QD	CE-326,597 50 mg QD	-
CE-326,597 25 mg QD	CE-326,597 25 mg QD	-
Placebo	Placebo	-
CE-326,597 5mg QD	CE-326,597 5mg QD	-

Primary Outcome Measures

Name	Time	Method
Glucose control	At Day 84
Body weight	At Day 84

Secondary Outcome Measures

Name	Time	Method
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.	Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulin	On Day 28
Regimen (dose or number) of anti-diabetic agents	At Day 84
GlycoMark	On Day 84
Waist circumference	On Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%	On Day 84
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.	Throughout Study

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Sevilla, Spain