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This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPP-IV Inhibitor | Drug | Escalating doses po bid or qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in HbAlc\n\n | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate | Week 12 | |
| AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salinas | California | 93901 | United States | |||
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| Placebo | Drug | po bid or qd |
|
| Clearwater |
| Florida |
| 33765 |
| United States |
| Hialeah | Florida | 33013 | United States |
| Pembroke Pines | Florida | 33029 | United States |
| Blue Ridge | Georgia | 30513 | United States |
| Aurora | Illinois | 60504 | United States |
| Elkton | Maryland | 21921 | United States |
| Oxon Hill | Maryland | 20745 | United States |
| Troy | Michigan | 48098 | United States |
| Pahrump | Nevada | 89048 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Portland | Oregon | 97239 | United States |
| Warminster | Pennsylvania | 18974 | United States |
| Dallas | Texas | 75246 | United States |
| Midland | Texas | 79707 | United States |
| San Antonio | Texas | 78229 | United States |
| Richmond | Virginia | 23249 | United States |
| Virginia Beach | Virginia | 23451 | United States |
| Rousse | 7002 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| San José | 755-1000 | Costa Rica |
| Tartu | 50406 | Estonia |
| Tartu | 51014 | Estonia |
| Ogre | 5001 | Latvia |
| Riga | 1002 | Latvia |
| Klaipėda | 92304 | Lithuania |
| Vilnius | 08661 | Lithuania |
| Chihuahua City | 31238 | Mexico |
| Guadalajara | 44340 | Mexico |
| Guadalajara | 44650 | Mexico |
| Mexico City | 06726 | Mexico |
| Mexico City | 14000 | Mexico |
| Monterrey | 64460 | Mexico |
| Pachuca | 42086 | Mexico |
| Ponce | 00716 | Puerto Rico |
| Bucharest | 020475 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Ploieşti | 100163 | Romania |
| Târgu Mureş | 540011 | Romania |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
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