| Trial ID: | L5712 |
| Source ID: | NCT01511900
|
| Associated Drug: |
Cat 1004
|
| Title: |
A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: CAT 1004|DRUG: Placebo|DRUG: CAT 1004|DRUG: CAT 1004|DRUG: CAT 1004|DRUG: CAT 1004
|
| Outcome Measures: |
Primary: Frequency and severity of adverse events, Screening to Follow-up (Day 25) | Secondary: AUCinf of CAT-1004, Days 1, 7 and 14|Glucose area under the curve for 0-24 hrs/24 and 0-4 hrs/4, Day -2 through f/u (Day 25)|Cmax of CAT-1004, Days 1, 7 and 14|Changes from baseline for hematology, chemistry, coagulation and urinalysis, Baseline through End of study (Day 25)|Changes from baseline for Physical exams, Baseline through end of study (Day 25)|Changes from baseline for ECGs, Baseline through end of study (Day 25)|Changes from baseline in vital signs, Baseline through end of study (Day 25)
|
| Sponsor/Collaborators: |
Sponsor: Catabasis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose:
|
| Start Date: |
2011-12
|
| Completion Date: |
2012-04
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-08
|
| Locations: |
Chula Vista, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01511900
|
