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This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 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 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPP-IV Inhibitor | Drug | Escalating doses po bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in HbAlc\n | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n | Week 16 | |
| 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 |
|---|---|---|---|---|---|---|
| Concord | California | 94520 | United States | |||
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| Metformin |
| Drug |
As prescribed |
|
| Placebo | Drug | po bid |
|
| Salinas |
| California |
| 93901 |
| United States |
| San Diego | California | 92161 | United States |
| Boulder | Colorado | 80304 | United States |
| Newark | Delaware | 19713 | United States |
| Wilmington | Delaware | 19085 | United States |
| Clearwater | Florida | 33765 | United States |
| Miami | Florida | 33156 | United States |
| Chicago | Illinois | 60607 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Buffalo | New York | 14209 | United States |
| Rochester | New York | 14609 | United States |
| Durham | North Carolina | 27713 | United States |
| Mogadore | Ohio | 44260 | United States |
| Portland | Oregon | 97239 | United States |
| Connellsville | Pennsylvania | 15425 | United States |
| Warminster | Pennsylvania | 18974 | United States |
| Dallas | Texas | 75246 | United States |
| Midland | Texas | 79707 | United States |
| San Antonio | Texas | 78229 | United States |
| Adelaide | 5000 | Australia |
| Sydney | 2050 | Australia |
| Winnipeg | Manitoba | R3E 3P4 | Canada |
| Halifax | Nova Scotia | B3H 1V7 | Canada |
| London | Ontario | NGA 4V2 | Canada |
| Toronto | Ontario | M5C 2T2 | Canada |
| Bad Lauterberg im Harz | 37431 | Germany |
| Berlin | 10115 | Germany |
| Dresden | 01307 | Germany |
| Görlitz | 02826 | Germany |
| Mainz | 55116 | Germany |
| Neuss | 41460 | Germany |
| Ancona | 60131 | Italy |
| Florence | 50100 | Italy |
| Naples | 80100 | Italy |
| Udine | 33100 | Italy |
| Ponce | 00716 | Puerto Rico |
| 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 |
| D008687 | Metformin |
| 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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