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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011589-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| SLV337 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in alanine amino transferase level to Day 35 | 35 days | |
| Change from baseline in Creatinine level to Day 35 | 35 days | |
| Change from baseline in the count of Red blood cells to Day 35 | 35 days | |
| Change from baseline in White blood cells count to Day 35 | 35 days | |
| Change from baseline in Creatinine kinase level to Day 35 | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fasting plasma glucose level to Day 28 | 28 days | |
| Change from baseline in Adiponectin level to Day 28 | 28 days | |
| Change from baseline in Triglycerides level to Day 28 |
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Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c >= 7%, but < 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) >40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT > 1.5 times UNL, creatinine clearance <60 mL/min
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| Name | Affiliation | Role |
|---|---|---|
| Francis Roy, MS | Abbott Products | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 54183 | Dimitrovgrad | 6400 | Bulgaria | |||
| Site Reference ID/Investigator# 54182 |
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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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| Drug |
SLV337 400 mg/day |
|
| SLV337 | Drug | SLV337 800 mg/day |
|
| SLV337 | Drug | SLV337 1400 mg/day |
|
| 28 days |
| Change from baseline in High density lipoprotein cholesterol level to Day 28 | 28 days |
| Pleven |
| 5800 |
| Bulgaria |
| Site Reference ID/Investigator# 44722 | Plovdiv | 4000 | Bulgaria |
| Site Reference ID/Investigator# 44723 | Sofia | 1407 | Bulgaria |
| Site Reference ID/Investigator# 44725 | Lubin | 59-301 | Poland |
| Site Reference ID/Investigator# 44724 | Puławy | 24-100 | Poland |
| Site Reference ID/Investigator# 54185 | Radzymin | 05-250 | Poland |
| Site Reference ID/Investigator# 44727 | Ruda Śląska | Poland |
| Site Reference ID/Investigator# 54184 | Wroclaw | 50-349 | Poland |
| Site Reference ID/Investigator# 44728 | Cape Town | 7130 | South Africa |
| Site Reference ID/Investigator# 44730 | Cape Town | 7937 | South Africa |
| Site Reference ID/Investigator# 44729 | Johannesburg | 2198 | South Africa |
| D004700 | Endocrine System Diseases |