The purpose of this study is to evaluate the safety and tolerance of a single intravenous
(through a vein) dose of trodusquemine (MSI-1436) in obese, 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).
1. male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years
2. either treatment naive or who are inadequately controlled on either metformin alone
or metformin in combination with a sulfonylurea. Subjects on metformin in combination
with a sulfonylurea will be allowed a 2 week period to wash out the sulfonylurea
3. have a fasting blood sugar of ≥ 100 mg/dL, hemoglobin A1C ≥ 7.5% (but ≤ 11.0%).
Subjects on a combination of metformin and sulfonylurea must have a hemoglobin A1C ≥
7.5% (but ≤ 10.0%);
5. body mass index (BMI) of 27-40 kg/m2
1. likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for
Injection based on known allergies to drugs of the same class;
2. any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to
any medications, either prescription or nonprescription, including dietary
supplements or herbal medications;
3. any subject with a history of severe allergy or bronchial asthma;
4. a clinically significant history of or current abnormality or disease of any organ
system, including renal, hepatic, gastrointestinal, cardiovascular (except
hyperlipidemia or controlled hypertension), pulmonary (including chronic asthma),
endocrine (except diabetes), central nervous, or hematologic systems, or recent
clinically significant surgery;