Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434744
• Other study ID #: KD026-201
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2023
• Source: Response Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• KD026
Dosed in combination
• Placebo
Dosed in combination
• Metformin
Drug prescribed by each subject's prescribing physician

Locations

Country	Name	City	State
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	High Point Clinical Trials Center	High Point	North Carolina
United States	Clinical Trial Network	Houston	Texas
United States	Axis Clinical Trials	Los Angeles	California
United States	National Research Institute	Los Angeles	California
United States	Med Research of Florida, LLC	Miami	Florida
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Infosphere Clinical Research, Inc	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Response Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Fasting Plasma Glucose (FPG)	To assess changes in fasting plasma glucose from baseline to Week 12	12 Weeks
Secondary	Changes in Insulin	To assess changes in insulin from baseline to Week 12	12 Weeks
Secondary	Changes in HOMA-IR	To assess changes in Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) from baseline to Week 12	12 Weeks
Secondary	Changes in Body Weight	To assess changes in body weight	12 Weeks
Secondary	Changes in AUC	To assess the 6-hour time curve (AUC) for post prandial triglycerides and glucose.	12 Weeks
Secondary	Changes in Lipids	To assess changes in total cholesterol, LDL-C, HDL-C, non-HDL-C, VLDL-C, and triglyceride levels	12 Weeks
Secondary	Changes in Blood Pressure	To assess changes, if any, in baseline blood pressure associated with metabolic syndrome	12 Weeks
Secondary	Changes in Waist Circumference	To assess changes, if any, in baseline waist circumference associated with metabolic syndrome	12 Weeks
Secondary	Changes in Body Mass Index (BMI)	To assess changes, if any, in baseline measures of BMI associated with metabolic syndrome	12 Weeks
Secondary	Changes in Plasma Levels of KD026	To assess plasma levels of KD026 in all subjects	12 Weeks
Secondary	Changes in Serum Levels of Non-Esterified Free Fatty Acids	To assess the change in serum levels of non-esterified free fatty acids from baseline to Week 12	12 Weeks