This study will compare the safety, tolerability and efficacy of the combination of KD026 and metformin compared to placebo and metformin on improving glycemic control in patients with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Axis Clinical Trials
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
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
Time frame: 12 Weeks
Changes in Fasting Plasma Glucose (FPG)
To assess changes in fasting plasma glucose from baseline to Week 12
Time frame: 12 Weeks
Changes in Insulin
To assess changes in insulin from baseline to Week 12
Time frame: 12 Weeks
Changes in HOMA-IR
To assess changes in Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) from baseline to Week 12
Time frame: 12 Weeks
Changes in Body Weight
To assess changes in body weight
Time frame: 12 Weeks
Changes in AUC
To assess the 6-hour time curve (AUC) for post prandial triglycerides and glucose.
Time frame: 12 Weeks
Changes in Lipids
To assess changes in total cholesterol, LDL-C, HDL-C, non-HDL-C, VLDL-C, and triglyceride levels
Time frame: 12 Weeks
Changes in Blood Pressure
To assess changes, if any, in baseline blood pressure associated with metabolic syndrome
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Infosphere Clinical Research, Inc
West Hills, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Med Research of Florida, LLC
Miami, Florida, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Trial Network
Houston, Texas, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Time frame: 12 Weeks
Changes in Waist Circumference
To assess changes, if any, in baseline waist circumference associated with metabolic syndrome
Time frame: 12 Weeks
Changes in Body Mass Index (BMI)
To assess changes, if any, in baseline measures of BMI associated with metabolic syndrome
Time frame: 12 Weeks
Changes in Plasma Levels of KD026
To assess plasma levels of KD026 in all subjects
Time frame: 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
Time frame: 12 Weeks