| Trial ID: | L2855 |
| Source ID: | NCT00963768
|
| Associated Drug: |
Jnj 28431754
|
| Title: |
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: JNJ 28431754|DRUG: Placebo
|
| Outcome Measures: |
Primary: The number of patients with adverse events as a measure of safety and tolerability, Up to 34 days (baseline [Day -1] through follow up [10 days following Day 22 visit]) | Secondary: Change from baseline (Day -1) for mean 24-hour plasma glucose concentration, Day -1 through Day 16|Change from baseline 24-hour urinary glucose excretion (UGE), Day -1 through 16|Change from baseline mean fasting plasma glucose, Day -1 through Day 16|Change from baseline mean morning fasting body weight, Day -1 through 20|Renal glucose threshold, Day -1 through Day 16
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
116
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-06
|
| Completion Date: |
2007-12
|
| Results First Posted: |
|
| Last Update Posted: |
2014-04-23
|
| Locations: |
Chula Vista, California, United States|Neuss, Germany|Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00963768
|
