| Trial ID: | L7200 |
| Source ID: | NCT03406377
|
| Associated Drug: |
Opk-88003
|
| Title: |
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03406377/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: OPK-88003|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c in Subjects With Type 2 DM, To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin., From baseline to 30 weeks | Secondary: Mean Percent (%) Body Weight Change, Mean percent (%) body weight change from baseline to after 30 weeks treatment, From baseline to 30 weeks|Percent (%) of Subjects With 5% or Greater Body Weight Loss., Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment, 30 weeks.|Change From Baseline of Fasting Plasma Glucose (FPG)., Change of FPG from baseline to after 30 weeks treatment, 30 weeks.
|
| Sponsor/Collaborators: |
Sponsor: OPKO Health, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
113
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-04-02
|
| Completion Date: |
2019-06-27
|
| Results First Posted: |
2021-06-15
|
| Last Update Posted: |
2021-06-15
|
| Locations: |
National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|Clinical Pharmacology of Miami, LLC, Hialeah, Florida, 33014, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03406377
|
