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

November 14, 2023 updated by: Response Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
    • California
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • West Hills, California, United States, 91307
        • Infosphere Clinical Research, Inc
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Miami, Florida, United States, 33186
        • Med Research of Florida, LLC
    • North Carolina
      • High Point, North Carolina, United States, 27265
        • High Point Clinical Trials Center
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Texas
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 100 mg KD026 BID
100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks
Drug: KD026
Dosed in combination
Other Names:
  • SLx-4090
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Experimental: Cohort 2 150 mg KD026 BID
150 mg KD026 BID in combination with Metformin for 12 weeks
Drug: KD026
Dosed in combination
Other Names:
  • SLx-4090
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Experimental: Cohort 3 200 mg KD026 BID
200 mg KD026 BID in combination with Metformin for 12 weeks
Drug: KD026
Dosed in combination
Other Names:
  • SLx-4090
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Experimental: Cohort 4 100 mg KD026 TID
100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks
Drug: KD026
Dosed in combination
Other Names:
  • SLx-4090
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Placebo Comparator: Cohort 1 Placebo
Matched Placebo Dose BID in combination with Metformin for 12 weeks
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Drug: Placebo
Dosed in combination
Placebo Comparator: Cohort 2 Placebo
Matched Placebo Dose BID in combination with Metformin for 12 weeks
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Drug: Placebo
Dosed in combination
Placebo Comparator: Cohort 3 Placebo
Matched Placebo Dose BID in combination with Metformin for 12 weeks
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Drug: Placebo
Dosed in combination
Placebo Comparator: Cohort 4 Placebo
Matched Placebo Dose TID in combination with Metformin for 12 weeks
Drug: Metformin
Drug prescribed by each subject's prescribing physician
Drug: Placebo
Dosed in combination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects Experiencing Adverse Events as a Measure of Safety, Tolerability, and Efficacy
Time Frame: 12 Weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Fasting Plasma Glucose (FPG)
Time Frame: 12 Weeks
To assess changes in fasting plasma glucose from baseline to Week 12
12 Weeks
Changes in Insulin
Time Frame: 12 Weeks
To assess changes in insulin from baseline to Week 12
12 Weeks
Changes in HOMA-IR
Time Frame: 12 Weeks
To assess changes in Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) from baseline to Week 12
12 Weeks
Changes in Body Weight
Time Frame: 12 Weeks
To assess changes in body weight
12 Weeks
Changes in AUC
Time Frame: 12 Weeks
To assess the 6-hour time curve (AUC) for post prandial triglycerides and glucose.
12 Weeks
Changes in Lipids
Time Frame: 12 Weeks
To assess changes in total cholesterol, LDL-C, HDL-C, non-HDL-C, VLDL-C, and triglyceride levels
12 Weeks
Changes in Blood Pressure
Time Frame: 12 Weeks
To assess changes, if any, in baseline blood pressure associated with metabolic syndrome
12 Weeks
Changes in Waist Circumference
Time Frame: 12 Weeks
To assess changes, if any, in baseline waist circumference associated with metabolic syndrome
12 Weeks
Changes in Body Mass Index (BMI)
Time Frame: 12 Weeks
To assess changes, if any, in baseline measures of BMI associated with metabolic syndrome
12 Weeks
Changes in Plasma Levels of KD026
Time Frame: 12 Weeks
To assess plasma levels of KD026 in all subjects
12 Weeks
Changes in Serum Levels of Non-Esterified Free Fatty Acids
Time Frame: 12 Weeks
To assess the change in serum levels of non-esterified free fatty acids from baseline to Week 12
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Response Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KD026-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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