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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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:

MedlinePlus related topics: Body Weight

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Glucose control [ Time Frame: At Day 84 ]
Body weight [ Time Frame: At Day 84 ]

Secondary Outcome Measures:

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


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 (Adult)
Sexes Eligible for Study:	All
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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


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

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 July 27, 2017

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