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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00542009

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
Obesity Diabetes Mellitus, Type 2 Overweight	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 II

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Dextrose

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Arms	Assigned Interventions
CE-326,597 100 mg QD: Experimental	Drug: CE-326,597 100 mg QD Administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 50 mg QD: Experimental	Drug: CE-326,597 50 mg QD Administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 25 mg QD: Experimental	Drug: CE-326,597 25 mg QD Administered orally, once daily with morning meal for duration of trial (84 days).
Placebo: Placebo Comparator	Drug: Placebo Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 5mg QD: Experimental	Drug: CE-326,597 5mg QD Administered orally, once daily with morning meal for duration of trial (84 days).

Eligibility

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7211005
Study First Received:	October 5, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00542009
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.

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 15, 2009