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| Name | Class |
|---|---|
| Integrium | INDUSTRY |
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This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Placebo |
|
| Arm 2 | Experimental | Biphasic remogliflozin etabonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biphasic Remogliflozin Etabonate | Drug | Experimental Drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated haemoglobin A1c (HbA1c) at Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | at weeks 4, 8 and 12 | |
| Fasting plasma glucose (FPG) | at Weeks 4, 8 and 12 | |
| Insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel M Neutel, MD | Orange County Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Arizona Clinical Research | Tucson | Arizona | 85712 | United States | ||
| Long Beach Clinical Trials |
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| Other |
Placebo Comparator |
|
| at Weeks 4, 8 and 12 |
| C-peptide | at Weeks 4, 8 and 12 |
| Total Cholesterol | at Weeks 4, 8 and 12 |
| LDL-c | at Weeks 4, 8 and 12 |
| HDL-c | at Weeks 4, 8 and 12 |
| Serum Triglycerides | at Weeks 4, 8 and 12 |
| Body Weight | at Weeks 4, 8 and 12 |
| Waist Circumference | at Weeks 4, 8 and 12 |
| Adverse Events (AE) | Over 12 weeks |
| Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests | 12 weeks |
| Long Beach |
| California |
| 90806 |
| United States |
| Long Beach Center for Clinical Research | Long Beach | California | 90807 | United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Chase Medical Research | Waterbury | Connecticut | 06708 | United States |
| Medical Research Unlimited | Hialeah | Florida | 33012 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Meridien Research | Tampa | Florida | 33634 | United States |
| eStudySite, Las Vegas | Las Vegas | Nevada | 89109 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| Albuquerque Clinical Trials, Inc | Albuquerque | New Mexico | 87102 | United States |
| Mountain View Clinical Research | Greer | South Carolina | 29651 | United States |
| New Phase Research & Development | Knoxville | Tennessee | 37909 | United States |
| Austin Center for Clinical Research | Austin | Texas | 78756 | United States |
| Padre Coast Clinical Research | Corpus Christi | Texas | 78404 | United States |
| Juno Research, LLC | Houston | Texas | 77074 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| 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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