| Trial ID: | L4775 |
| Source ID: | NCT00806338
|
| Associated Drug: |
Trodusquemine (Msi-1436)
|
| Title: |
An Ascending Multi-Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Obesity
|
| Interventions: |
DRUG: Trodusquemine (MSI-1436)|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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 | Secondary: Effect on glucose tolerance or glucose/insulin relationships, 6 months|Effect on appetite and food consumption, 6 months|Effect on behavior and mood, 6 months|Effect on exploratory biomarkers, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Genaera Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-11
|
| Completion Date: |
2009-04
|
| Results First Posted: |
|
| Last Update Posted: |
2009-04-15
|
| Locations: |
Cetero Research, Miami Gardens, Florida, 33169, United States|dgd Research, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00806338
|
