| Trial ID: | L6777 |
| Source ID: | NCT00952198
|
| Associated Drug: |
Arry-403, Glucokinase Activator; Oral
|
| Title: |
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: ARRY-403, glucokinase activator; oral|DRUG: Placebo; oral
|
| Outcome Measures: |
Primary: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms., Duration of study|Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations., 10 days | Secondary: Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT)., 10 days|Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers., 10 days
|
| Sponsor/Collaborators: |
Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
128
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-08
|
| Completion Date: |
2010-08
|
| Results First Posted: |
|
| Last Update Posted: |
2020-10-06
|
| Locations: |
Profil Institute for Clinical Research, Chula Vista, California, 91911, United States|Cetero, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00952198
|
