| Trial ID: | L1988 |
| Source ID: | NCT01843127
|
| Associated Drug: |
Ranolazine
|
| Title: |
A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Ranolazine|DRUG: Placebo|DRUG: Exenatide
|
| Outcome Measures: |
Primary: Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT), Days 5, 10, and 14 | Secondary: Plasma glucose, serum insulin, and serum C-peptide AUCs during the SMT, Days 5, 10, and 14|Collapse under Acetaminophen PK, Days 5 and 10|Area under the plasma acetaminophen concentration-time curve from time 0 to 240 min (AUC0-240 min), Days 5 and 10|Collapse all under ranolazine pharmacokinetics (PK), Days 5 and 10|Trough plasma ranolazine concentrations (Ctrough), Days 5 and 10|Average plasma ranolazine concentration during a dosing interval at steady state (Css,ave), Days 5 and 10|Area under the plasma ranolazine concentration-time curve over dosing interval (AUCtau), Days 5 and 10|Apparent elimination half-life (t1/2) of ranolazine, Days 5 and 10|Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments., From Screening to 7 days after the final dose
|
| Sponsor/Collaborators: |
Sponsor: Gilead Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-04
|
| Completion Date: |
2013-09
|
| Results First Posted: |
|
| Last Update Posted: |
2014-03-31
|
| Locations: |
Profil Institute for Clinical Research, Inc., Chula Vista, California, 91911, United States|SeaView Research, Inc, Miami, Florida, 33126, United States|Translational Research Institute-Florida Hospital, Orlando, Florida, 32804, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01843127
|
