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Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CE-326,597 100 mg QD | Experimental |
| |
| CE-326,597 50 mg QD | Experimental |
| |
| CE-326,597 25 mg QD | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| CE-326,597 5mg QD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-326,597 100 mg QD | Drug | Administered orally, once daily with morning meal for duration of trial (84 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose control | At Day 84 | |
| Body weight | At Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Regimen (dose or number) of anti-diabetic agents | At Day 84 | |
| GlycoMark | On Day 84 | |
| Waist circumference |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| CE-326,597 50 mg QD | Drug | Administered orally, once daily with morning meal for duration of trial (84 days). |
|
| CE-326,597 25 mg QD | Drug | Administered orally, once daily with morning meal for duration of trial (84 days). |
|
| Placebo | Drug | 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 | Drug | Administered orally, once daily with morning meal for duration of trial (84 days). |
|
| On Day 84 |
| Proportion of subjects who achieve HbA1C <7% and <6.5% | 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. | Throughout Study |
| Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial. | Throughout Study |
| Change in following parameters: Post-prandial and fasting glucose, and insulin | On Day 28 |
| Fresno |
| California |
| 93720 |
| United States |
| Pfizer Investigational Site | National City | California | 91950 | United States |
| Pfizer Investigational Site | San Diego | California | 92128 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Conyers | Georgia | 30094 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96814 | United States |
| Pfizer Investigational Site | Idaho Falls | Idaho | 83404 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60607 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60654 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Bethesda | Maryland | 20817 | United States |
| Pfizer Investigational Site | Chaska | Minnesota | 55318 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39202 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89052 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89101 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89117 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58103 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45249 | United States |
| Pfizer Investigational Site | Lansdale | Pennsylvania | 19446 | United States |
| Pfizer Investigational Site | Rapid City | South Dakota | 57702 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77701 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77706 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Pleven | 5800 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1431 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1606 | Bulgaria |
| Pfizer Investigational Site | Stara Zagora | 6000 | Bulgaria |
| Pfizer Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3a 1R9 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Pfizer Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3A 1A1 | Canada |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 052 | India |
| Pfizer Investigational Site | Indore | Madhya Pradesh | 452 001 | India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440 012 | India |
| Pfizer Investigational Site | Nashik | Maharashtra | 422 013 | India |
| Pfizer Investigational Site | Ladrón de Guevara | Guadalajara, Jalisco | 44656 | Mexico |
| Pfizer Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Ponce | 00716 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00909 | Puerto Rico |
| Pfizer Investigational Site | Tao Baja | 00949 | Puerto Rico |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | Santiago de Compostela | La Coruña | 15706 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41013 | Spain |