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Type 2 Diabetes MellitusPhase 2NCT02434744

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

A Phase 2 study testing KD026 and Metformin in people with Type 2 Diabetes Mellitus, run by Response Pharmaceuticals at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
KD026 and Metformin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
10 sitesUnited States
Study dates
Apr 2015to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • High Point Clinical Trials Center

    High Point, North Carolina, 27265

  • Clinical Trial Network

    Houston, Texas, 77074

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • National Research Institute

    Los Angeles, California, 90057

  • Med Research of Florida, LLC

    Miami, Florida, 33186

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Infosphere Clinical Research, Inc

    West Hills, California, 91307

Other trials in United States

About this study

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

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.

Being tested
KD026, Placebo, Metformin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KD026Drug

    Also called SLx-4090

    Dosed in combination

  • PlaceboDrug

    Dosed in combination

  • MetforminDrug

    Drug prescribed by each subject's prescribing physician

Study groups in NCT02434744
Study groupRoleWhat they receive
Cohort 1 100 mg KD026 BIDExperimental100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks
Receives: Drug: KD026; Drug: Metformin
Cohort 2 150 mg KD026 BIDExperimental150 mg KD026 BID in combination with Metformin for 12 weeks
Receives: Drug: KD026; Drug: Metformin
Cohort 3 200 mg KD026 BIDExperimental200 mg KD026 BID in combination with Metformin for 12 weeks
Receives: Drug: KD026; Drug: Metformin
Cohort 4 100 mg KD026 TIDExperimental100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks
Receives: Drug: KD026; Drug: Metformin
Cohort 1 PlaceboPlacebo comparatorMatched Placebo Dose BID in combination with Metformin for 12 weeks
Receives: Drug: Placebo; Drug: Metformin
Cohort 2 PlaceboPlacebo comparatorMatched Placebo Dose BID in combination with Metformin for 12 weeks
Receives: Drug: Placebo; Drug: Metformin
Cohort 3 PlaceboPlacebo comparatorMatched Placebo Dose BID in combination with Metformin for 12 weeks
Receives: Drug: Placebo; Drug: Metformin
Cohort 4 PlaceboPlacebo comparatorMatched Placebo Dose TID in combination with Metformin for 12 weeks
Receives: Drug: Placebo; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 Weeks

Secondary outcomes (11)

  1. Changes in Fasting Plasma Glucose (FPG)

    To assess changes in fasting plasma glucose from baseline to Week 12

    Measured: 12 Weeks

  2. Changes in Insulin

    To assess changes in insulin from baseline to Week 12

    Measured: 12 Weeks

  3. Changes in HOMA-IR

    To assess changes in Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) from baseline to Week 12

    Measured: 12 Weeks

  4. Changes in Body Weight

    To assess changes in body weight

    Measured: 12 Weeks

  5. Changes in AUC

    To assess the 6-hour time curve (AUC) for post prandial triglycerides and glucose.

    Measured: 12 Weeks

  6. Changes in Lipids

    To assess changes in total cholesterol, LDL-C, HDL-C, non-HDL-C, VLDL-C, and triglyceride levels

    Measured: 12 Weeks

  7. Changes in Blood Pressure

    To assess changes, if any, in baseline blood pressure associated with metabolic syndrome

    Measured: 12 Weeks

  8. Changes in Waist Circumference

    To assess changes, if any, in baseline waist circumference associated with metabolic syndrome

    Measured: 12 Weeks

  9. Changes in Body Mass Index (BMI)

    To assess changes, if any, in baseline measures of BMI associated with metabolic syndrome

    Measured: 12 Weeks

  10. Changes in Plasma Levels of KD026

    To assess plasma levels of KD026 in all subjects

    Measured: 12 Weeks

  11. 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

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02434744
Sponsor's protocol ID
KD026-201
Status last verified
Apr 2023
First submitted
28 Apr 2015
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KD026 and Metformin in people with Type 2 Diabetes Mellitus, run by Response Pharmaceuticals at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Experiencing Adverse Events as a Measure of Safety, Tolerability, and Efficacy (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02434744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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