| Trial ID: | L3207 |
| Source ID: | NCT01177163
|
| Associated Drug: |
Placebo
|
| 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: Placebo|DRUG: JNJ 28431754 300 mg/placebo|DRUG: JNJ 28431754 100 mg/placebo
|
| Outcome Measures: |
Primary: The proportion of patients who need to decrease insulin dosage from prestudy dosage levels because of hypoglycemia, From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal|The number of patients with specific treatment-emergent adverse events, From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal|The number of patients with symptomatic hypoglycemia and severe hypoglycemia, From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal | Secondary: Plasma concentrations and pharmacokinetics parameters for JNJ 28431754, At protocol-specified timepoints from Day 1 (pre-dose) to Day 29|Plasma glucose concentration-time profiles (pharmacodynamics parameter), At protocol specified timepoints on Day -1, Day 1, and Day 27|Change in urine glucose excretion (pharmacodynamics parameter), At protocol specified timepoints on Day -1, Day 1, and Day 27
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
29
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-05
|
| Completion Date: |
2009-03
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-29
|
| Locations: |
Chula Vista, California, United States|San Antonio, Texas, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01177163
|
