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The purpose of this study is to evaluate the safety and tolerance of multiple intravenous (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436). Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trodusquemine (MSI-1436) 3mg/m2 | Experimental |
| |
| Trodusquemine (MSI-1436) 6mg/m2 | Experimental |
| |
| Trodusquemine (MSI-1436) 10mg/m2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trodusquemine (MSI-1436) | Drug | A single dose of Trodusquemine (MSI-1436) will be administered every 72 hours on Days 0, 3, 6, 9, 12, 15, 18 and 21. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2 and 10mg/m2 in cohort 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerance of multiple intravenous doses of trodusquemine (MSI-1436) in obese or overweight type 2 diabetics. Safety will be evaluated by physical exams, vital signs assessments, 12-lead ECGs, clinical lab tests and adverse event profile. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on glucose tolerance or glucose/insulin relationships | 6 months | |
| Effect on appetite and food consumption | 6 months | |
| Effect on behavior and mood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kipnes, MD | dgd Research | Principal Investigator |
| Gilbert Weiner, D.O. AOBFP | Cetero Research, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Miami Gardens | Florida | 33169 | United States | ||
| dgd Research |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C441128 | 3-N-1(spermine)-7, 24-dihydroxy-5-cholestane 24-sulfate |
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| Placebo | Drug |
|
| 6 months |
| Effect on exploratory biomarkers | 6 months |
| San Antonio |
| Texas |
| 78229 |
| United States |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |