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This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 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 | Experimental |
| |
| 6 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK Activator (2) | Drug | Escalating doses, po bid or qd for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c mean change from baseline compared with placebo. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional parameters of glycemic and lipid control. | Week 12 | |
| AEs, laboratory parameters. | Throughout study | |
| Pharmacokinetic and exposure-response relationship |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85012 | United States | |||
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| Metformin | Drug | As prescribed, for 12 weeks |
|
| Throughout study |
| Chula Vista |
| California |
| 91910 |
| United States |
| Los Angeles | California | 90057 | United States |
| Kissimmee | Florida | 34741 | United States |
| Tampa | Florida | 33603 | United States |
| Lawrenceville | Georgia | 30045 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Benzonia | Michigan | 49616 | United States |
| Springfield | Missouri | 65804 | United States |
| Butte | Montana | 59701 | United States |
| Kettering | Ohio | 45429 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Medford | Oregon | 97504 | United States |
| Morrisville | Pennsylvania | 19067 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Memphis | Tennessee | 38119 | United States |
| Bellevue | Washington | 98004 | United States |
| Federal Way | Washington | 98003 | United States |
| Adelaide | 5000 | Australia |
| Heidelberg | 3081 | Australia |
| Sydney | 2050 | Australia |
| Edmonton | Alberta | T5N 3Y6 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| London | Ontario | NGA 4V2 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Sherbrooke | Quebec | J1H 4J6 | Canada |
| Bammental | 69245 | Germany |
| Berlin | 10115 | Germany |
| Essen | 45355 | Germany |
| Giessen | 35385 | Germany |
| Görlitz | 02826 | Germany |
| Hamburg | 20249 | Germany |
| Künzing | 94550 | Germany |
| Mannheim | 68161 | Germany |
| Nuremberg | 90402 | Germany |
| Tann | 36142 | Germany |
| Alzira | 46600 | Spain |
| Bacarot Alicant | 03114 | Spain |
| Barakaldo | 48903 | Spain |
| Barcelona | 08036 | Spain |
| Dundee | DD1 5LA | United Kingdom |
| Frome | BA11 1EZ | United Kingdom |
| Glasgow | G45 9AW | United Kingdom |
| Liverpool | L9 7AL | United Kingdom |
| Motherwell | ML1 3JX | United Kingdom |
| Northwood | HA6 2RN | United Kingdom |
| Plymouth | PL6 7TH | United Kingdom |
| 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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