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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542009
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : December 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Glucose control [ Time Frame: At Day 84 ]
  2. Body weight [ Time Frame: At Day 84 ]

Secondary Outcome Measures :
  1. Regimen (dose or number) of anti-diabetic agents [ Time Frame: At Day 84 ]
  2. GlycoMark [ Time Frame: On Day 84 ]
  3. Waist circumference [ Time Frame: On Day 84 ]
  4. Proportion of subjects who achieve HbA1C <7% and <6.5% [ Time Frame: On Day 84 ]
  5. 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 ]
  6. Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial. [ Time Frame: Throughout Study ]
  7. Change in following parameters: Post-prandial and fasting glucose, and insulin [ Time Frame: On Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542009


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00542009    
Other Study ID Numbers: A7211005
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Keywords provided by Pfizer:
Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.
Additional relevant MeSH terms:
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Body Weight