| Trial ID: | L2875 |
| Source ID: | NCT02434744
|
| Associated Drug: |
Kd026
|
| Title: |
Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: KD026|DRUG: Placebo|DRUG: Metformin
|
| Outcome Measures: |
Primary: Number of Subjects Experiencing Adverse Events as a Measure of Safety, Tolerability, and Efficacy, To assess the safety, tolerability, and efficacy (as measured by a 0.5%-1.5% decrease of HbA1c) of different dosages and dosing regimens of a combination of KD026 and metformin compared to placebo and metformin when administered for 3 months to subjects with type 2 diabetes mellitus, 12 Weeks | Secondary: Changes in Fasting Plasma Glucose (FPG), To assess changes in fasting plasma glucose from baseline to Week 12, 12 Weeks|Changes in Insulin, To assess changes in insulin from baseline to Week 12, 12 Weeks|Changes in HOMA-IR, To assess changes in Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) from baseline to Week 12, 12 Weeks|Changes in Body Weight, To assess changes in body weight, 12 Weeks|Changes in AUC, To assess the 6-hour time curve (AUC) for post prandial triglycerides and glucose., 12 Weeks|Changes in Lipids, To assess changes in total cholesterol, LDL-C, HDL-C, non-HDL-C, VLDL-C, and triglyceride levels, 12 Weeks|Changes in Blood Pressure, To assess changes, if any, in baseline blood pressure associated with metabolic syndrome, 12 Weeks|Changes in Waist Circumference, To assess changes, if any, in baseline waist circumference associated with metabolic syndrome, 12 Weeks|Changes in Body Mass Index (BMI), To assess changes, if any, in baseline measures of BMI associated with metabolic syndrome, 12 Weeks|Changes in Plasma Levels of KD026, To assess plasma levels of KD026 in all subjects, 12 Weeks|Changes in Serum Levels of Non-Esterified Free Fatty Acids, To assess the change in serum levels of non-esterified free fatty acids from baseline to Week 12, 12 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Response Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
121
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-04
|
| Completion Date: |
2016-03
|
| Results First Posted: |
|
| Last Update Posted: |
2023-11-18
|
| Locations: |
Achieve Clinical Research, LLC, Birmingham, Alabama, 35216, United States|Axis Clinical Trials, Los Angeles, California, 90036, United States|National Research Institute, Los Angeles, California, 90057, United States|Infosphere Clinical Research, Inc, West Hills, California, 91307, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|Med Research of Florida, LLC, Miami, Florida, 33186, United States|High Point Clinical Trials Center, High Point, North Carolina, 27265, United States|Coastal Carolina Research Center, Mount Pleasant, South Carolina, 29464, United States|Clinical Trial Network, Houston, Texas, 77074, United States|Clinical Research Associates of Tidewater, Norfolk, Virginia, 23507, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02434744
|
