Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments kd026, placebo, metformin
Phase phase 2
Sponsor Kadmon Corporation, LLC
Start date April 2015
End date March 2016
Trial size 120 participants
Trial identifier NCT02434744, KD026-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks
kd026 SLx-4090
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Experimental)
150 mg KD026 BID in combination with Metformin for 12 weeks
kd026 SLx-4090
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Experimental)
200 mg KD026 BID in combination with Metformin for 12 weeks
kd026 SLx-4090
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Experimental)
100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks
kd026 SLx-4090
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Placebo Comparator)
Matched Placebo Dose BID in combination with Metformin for 12 weeks
placebo
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Placebo Comparator)
Matched Placebo Dose BID in combination with Metformin for 12 weeks
placebo
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Placebo Comparator)
Matched Placebo Dose BID in combination with Metformin for 12 weeks
placebo
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician
(Placebo Comparator)
Matched Placebo Dose TID in combination with Metformin for 12 weeks
placebo
Dosed in combination with Metformin
metformin
Drug prescribed by each subject's prescribing physician

Primary Outcomes

Measure
Number of Subjects Experiencing Adverse Events as a Measure of Safety, Tolerability, and Efficacy
time frame: 12 Weeks

Secondary Outcomes

Measure
Changes in Fasting Plasma Glucose (FPG)
time frame: 12 Weeks
Changes in Insulin
time frame: 12 Weeks
Changes in HOMA-IR
time frame: 12 Weeks
Changes in Body Weight
time frame: 12 Weeks
Changes in AUC
time frame: 12 Weeks
Changes in Lipids
time frame: 12 Weeks
Changes in Blood Pressure
time frame: 12 Weeks
Changes in Waist Circumference
time frame: 12 Weeks
Changes in Body Mass Index (BMI)
time frame: 12 Weeks
Changes in Plasma Levels of KD026
time frame: 12 Weeks
Changes in Serum Levels of Non-Esterified Free Fatty Acids
time frame: 12 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Kadmon Corporation, LLC.