| A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight |
| 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 of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
- Weight Management
- Treatment Of Obesity
|
- Drug: CE-326,597 100 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
- Drug: CE-326,597 50 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
- Drug: CE-326,597 25 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
- Drug: Placebo
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
- Drug: CE-326,597 5mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
|
- Experimental: CE-326,597 100 mg QD
Intervention: Drug: CE-326,597 100 mg QD
- Experimental: CE-326,597 50 mg QD
Intervention: Drug: CE-326,597 50 mg QD
- Experimental: CE-326,597 25 mg QD
Intervention: Drug: CE-326,597 25 mg QD
- Placebo Comparator: Placebo
Intervention: Drug: Placebo
- Experimental: CE-326,597 5mg QD
Intervention: Drug: CE-326,597 5mg QD
|
| Not Provided |
| |
| Completed |
| 252 |
| November 2008 |
| November 2008 (Final data collection date for primary outcome measure) |
|
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
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 65 Years (Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Bulgaria, Canada, India, Mexico, Puerto Rico, Spain, United States |
| |
| |
| NCT00542009 |
| A7211005 |
| No |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2012 |
