A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
NCT ID: NCT00606112
Last Updated: 2009-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2008-01-31
2009-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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1
Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
2
Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
3
Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
4
Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
Interventions
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Trodusquemine (MSI-1436)
A single dose will be administered on Day 0. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2, 10mg/m2 in cohort 3 and 15mg/m2 in cohort 4/
Eligibility Criteria
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Inclusion Criteria
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 before dosing.
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%);
4. non-smoker
5. body mass index (BMI) of 27-40 kg/m2
Exclusion Criteria
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;
18 Years
55 Years
ALL
No
Sponsors
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Genaera Corporation
INDUSTRY
Responsible Party
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Genaera Corporation
Principal Investigators
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Mark Kipnes, MD
Role: PRINCIPAL_INVESTIGATOR
dgd Research
Gilbert R. Weiner, D.O. AOBFP
Role: PRINCIPAL_INVESTIGATOR
Allied Research International
Locations
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dgd Research
San Antonio, Texas, United States
Countries
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Other Identifiers
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MSI-1436C-103
Identifier Type: -
Identifier Source: org_study_id
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