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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

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). |
- Glucose control [ Time Frame: At Day 84 ]
- Body weight [ Time Frame: At Day 84 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 |
Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM. |
Body Weight |