Clinical trial NCT02434744: Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Number of Subjects Experiencing Adverse Events as a Measure of Safety, Tolerability, and Efficacy
timeFrame: 12 Weeks
Secondary outcomes:
measure: Changes in Fasting Plasma Glucose (FPG)
timeFrame: 12 Weeks
measure: Changes in Insulin
timeFrame: 12 Weeks
measure: Changes in HOMA-IR
timeFrame: 12 Weeks
measure: Changes in Body Weight
timeFrame: 12 Weeks
measure: Changes in AUC
timeFrame: 12 Weeks
measure: Changes in Lipids
timeFrame: 12 Weeks
measure: Changes in Blood Pressure
timeFrame: 12 Weeks
measure: Changes in Waist Circumference
timeFrame: 12 Weeks
measure: Changes in Body Mass Index (BMI)
timeFrame: 12 Weeks
measure: Changes in Plasma Levels of KD026
timeFrame: 12 Weeks
measure: Changes in Serum Levels of Non-Esterified Free Fatty Acids
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: West Hills
country: United States
facility: Infosphere Clinical Research, Inc
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: Med Research of Florida, LLC
state: Florida
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
References: