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On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.
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A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05175157 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05175157 | Drug | Tablet, 200 mg, twice daily, 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo | Baseline, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo | Weeks 0 and 4 | |
| Change from baseline in fasting plasma glucose | Weeks 0, 2, 4 and 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Orlando | Florida | 32809 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Drug |
Tablet, 0 mg, twice daily, 6 weeks |
|
| Change from baseline in Glycosylated Hemoglobin (HbA1c) |
| Weeks 0, 4 and 6 |
| Change from baseline in fasting total cholesterol | Weeks 0, 4 and 6 |
| Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT) | Weeks 0, 4 and 6 |
| Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT) | Weeks 0, 4 and 6 |
| Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT | Weeks 0, 4 and 6 |
| Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT | Weeks 0, 4 and 6 |
| Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR) | Weeks 0, 4 and 6 |
| Change from baseline in homeostatic model assessment for β-cell function (HOMA B) | Weeks 0, 4 and 6 |
| Plasma concentrations for PF-05175157 | Weeks 2, 4 and 6 |
| Percent change from baseline in body weight | Weeks 0, 4 and 6 |
| Change from baseline in low density lipoprotein cholesterol (LDL-C) | Weeks 0, 4 and 6 |
| Change from baseline in high density lipoprotein cholesterol (HDL-C) | Weeks 0, 4 and 6 |
| Change from baseline in triglycerides | Weeks 0, 4 and 6 |
| Change from baseline in non-HDL cholesterol | Weeks 0, 4 and 6 |
| Change from baseline in very low density lipoprotein (VLDL) | Weeks 0, 4 and 6 |
| D004700 | Endocrine System Diseases |