Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02434744
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2015-04-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1 100 mg KD026 BID
100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks
KD026
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 2 150 mg KD026 BID
150 mg KD026 BID in combination with Metformin for 12 weeks
KD026
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 3 200 mg KD026 BID
200 mg KD026 BID in combination with Metformin for 12 weeks
KD026
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 4 100 mg KD026 TID
100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks
KD026
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 1 Placebo
Matched Placebo Dose BID in combination with Metformin for 12 weeks
Placebo
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 2 Placebo
Matched Placebo Dose BID in combination with Metformin for 12 weeks
Placebo
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 3 Placebo
Matched Placebo Dose BID in combination with Metformin for 12 weeks
Placebo
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Cohort 4 Placebo
Matched Placebo Dose TID in combination with Metformin for 12 weeks
Placebo
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Interventions
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KD026
Dosed in combination
Placebo
Dosed in combination
Metformin
Drug prescribed by each subject's prescribing physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Response Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Axis Clinical Trials
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
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
Countries
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Other Identifiers
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KD026-201
Identifier Type: -
Identifier Source: org_study_id
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