Study of KD026 in Combination With Metformin in Subjects... | NCT02434744

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 100 mg KD026 BID	Experimental	100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks	Drug: KD026 Drug: Metformin
Cohort 2 150 mg KD026 BID	Experimental	150 mg KD026 BID in combination with Metformin for 12 weeks	Drug: KD026 Drug: Metformin
Cohort 3 200 mg KD026 BID	Experimental	200 mg KD026 BID in combination with Metformin for 12 weeks	Drug: KD026 Drug: Metformin
Cohort 4 100 mg KD026 TID	Experimental	100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks	Drug: KD026 Drug: Metformin
Cohort 1 Placebo	Placebo Comparator	Matched Placebo Dose BID in combination with Metformin for 12 weeks	Drug: Placebo Drug: Metformin
Cohort 2 Placebo

Name	Type	Description	Arm Group Labels	Other Names
KD026	Drug	Dosed in combination	Cohort 1 100 mg KD026 BID Cohort 2 150 mg KD026 BID Cohort 3 200 mg KD026 BID Cohort 4 100 mg KD026 TID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Facility	Status	City	State	ZIP	Country	Contacts
Achieve Clinical Research, LLC		Birmingham	Alabama	35216	United States
Axis Clinical Trials

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C559489	6-(4'-trifluoromethyl-6-methoxybiphenyl-2-ylcarboxamido)-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid phenyl ester
D008687	Metformin

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals