Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Response Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have type 2 diabetes, with finger stick HbA1c ≥ 7.0% and ≤ 11.0% at screening visit, and HbA1c via venipuncture ≥ 7.0% and ≤ 11.0 % at the Qualification visit
Have been on metformin for at least 12 weeks prior to screening visit and the metformin dose is not expected to change during the 4-week run-in period
Have a BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2
Men, post-menopausal women (defined as not having a menstrual period for at least 1 year), surgically sterile women (for at least 1 year), or women of childbearing potential with a negative pregnancy test within the last 24 hours
Women of childbearing potential and men whose partners are of childbearing potential must agree to use two forms of accepted methods of contraception during the course of the study and for 1 month after their last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) a vasectomized partner
You may not be if
Have type 1 diabetes
Taking antidiabetic medications other than or in addition to metformin
Have fasting plasma glucose \> 270 mg/dL at screening visit
Have a serum creatinine ≥1.7 mg/dL or glomerular filtration rate \<60 mL/min at screening visit
Have a history of diabetic retinopathy
Uncontrolled high blood pressure
Have a history of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 × the upper limit of normal (ULN) at screening visit.
Have a history of a malignant cancer (other than basal cell, localized cervical, or squamous cell carcinoma of the skin that has been removed)
Have a history or presence of gastrointestinal (GI) disease or major gastrointestinal surgery that, in the opinion of the investigator, could interfere with drug absorption
Currently using any of prohibited medications that cannot be stopped
Abuse alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units \[1 unit is equivalent to a half pint of beer, 1 serving of hard liquor, or one glass of wine\]
History or presence of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria within the 2 years prior to screening visit
Have a 12-lead ECG at screening visit that, in the opinion of the investigator, have abnormalities that may compromise safety in this study, including a QTc(F) interval (QT interval data corrected using Fridericia's formula) of \> 450 msec
Have a clinically significant abnormal laboratory result including thyroid-stimulating hormone (TSH) \>1.5 × ULN at screening visit
Have a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody/virus (HCV) or human immunodeficiency virus (HIV) antibodies at screening visit or a documented history of a positive result
Pregnant or lactating woman
Previously received KD026 (formerly named SLx-4090)
Participated in a trial with any investigational drug within 4 weeks prior to screening visit
Clareo Health | Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
