Diabetes Mellitus, Type 2Phase 2NCT02444910
Effects of KDT501 on Metabolic Features in Insulin Resistant Subjects
A Phase 2 study testing KDT501 in people with Diabetes Mellitus, Type 2, run by KinDex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
KDT501 is an orally administered product designed to help control impaired glucose and insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein receptors. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- KDT501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2015
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to the initiation of study procedures
- Age is 40-70 years
- Diagnosis IGT, IFG, or metabolic syndrome
- IGT is defined as: a) 2 hour OGTT glucose 140-199mg/dL and b) fasting glucose <126 mg/dL
- IFG is defined as: a) 2 hour OGTT glucose < 200 mg/dL and b) fasting glucose 100-125 mg/dL
- Metabolic syndrome is defined as meeting at least 3 of the following criteria: a) serum triglycerides >150 mg/dL; b) serum HDL<40 mg/dl (males) or <50 (females); c) BP>130/85 or on medical treatment; d) waist circumference >40" (males) or >35" (females); e)HbA1c>5.7%
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- Prior therapy for IGT and IFG may include diet alone
- HbA1c <7.0% within 28 days of registration
- Fasting plasma glucose <126 mg/dL within 28 days of registration
- Body mass index (BMI) ≥27 kg/m2
- Women of child-bearing potential have a negative serum pregnancy test result ≤28 days prior to registration and agree not to breastfeed during investigational treatment with KDT501 and for 28 days following the final dose of KDT501.
- All males and premenopausal females who have not been surgically sterilized have agreed to practice a method of birth control considered by the Investigator to be effective and medically acceptable for at least 14 days prior to registration, throughout treatment, and for 28 days following the final dose of KDT501.
- Adequate baseline hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges (obtained ≤28 days prior to registration):
- Hemoglobin >11.0 gm/dL
- Platelet Count ≥100 x 10^3/μL
- White Blood Count ≥2.0 x 103/μL and ≤15.0 x 103/μL
- Creatinine Clearance ≥60 mL/min
- Total Bilirubin ≤2 x upper limit of normal (ULN)
- Aspartate Transferase (AST) ≤2.5 x ULN
- Alanine Transferase (ALT) ≤2.5 x ULN
- INR< 1.5 and PTT <1.5 ULN
- World Health Organization (WHO) performance status 0-1
Who cannot join
- Prior or current history of T2DM
- Type 1 diabetes
- Subjects with IGT or IFG who have hypoglycemic unawareness and/or recurrent severe hypoglycemia
- NYHA CHF Class 2-4
- Any significant, active pulmonary disorder including FEV1 <60% predicted based on outpatient spirometry
- History of any significant cardiovascular disease, including arrhythmia, clinically significant ECG abnormality, uncontrolled hypertension, myocardial infarction or unstable angina pectoris within the past 6 months
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- History of HIV or AIDS
- Active Hepatitis B or C infection requiring therapy within the past 6 months
- History of any significant, active gastrointestinal disorder, including GERD>grade 2 severity
- History of gastrectomy or any other GI tract surgery that may affect digestion or absorption
- Positive fecal occult blood
- Concomitant therapy with anticoagulants, aspirin or aspirin containing products. Low dose aspirin (≤81 mg qd) is allowed if PT/INR and aPTT values are WNL.
- Any significant, active hematological disorder
- Concomitant therapy with CYP2C9 substrates or inhibitors
- Any major surgery (e.g., surgery requiring general anesthesia) ≤28 days prior to registration
- Systemic treatment on any investigational clinical trial ≤28 days prior to registration
- Systemic glucocorticoid or immunosuppressive therapy use ≤28 days prior to registration. Use of a short course (i.e., ≤1 day) of a glucocorticoid is acceptable to prevent a reaction to IV contrast used for CT scans. Topical and inhaled steroid medications are allowed.
- Any infection requiring parenteral antibiotic therapy or causing fever (i.e., temperature >100.5°F or >38.1°C) ≤7 days prior to registration
- A contraindication to the use of KDT501
- Any medical intervention, has any other condition, or has any other circumstance which, in the opinion of the Investigator or the KinDex Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky's Center for Clinical and Translational Science (CCTS)
Lexington, Kentucky, 40536-0298
About this study
KDT501 is an orally administered product designed to help control impaired glucose and insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin sensitivity and glucose regulation as well as reduce proinflammatory signals. These properties combined with antihyperglycemic activity and modest, partial agonist effect of KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an atypical and pleiotropic mechanism of action for KDT501.
Following providing informed consent, potential subjects will undergo screening procedures to ensure that they meet all inclusion and exclusion criteria. Following registration on study, subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies, one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in registered subjects will be performed within 7 days prior to initiating therapy. On the first day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic, followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects will return to the clinic for PK studies, as noted below. Treatment in all subjects will end on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7 and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- KDT501
- Keywords
- KDT501, Diabetes, Diabetes Mellitus, Type 2, KinDex
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDT501Drug
600mg twice daily, Oral, for 10days; then 800mg twice daily, Oral, for 10 days; then 1,000mg twice daily, Oral, for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| KDT501 | Experimental | Experimental drug, KDT501, is administered at 600mg for 10 consecutive days. On days 11 and 21 (+/- 1 day), based on the KDT501 drug exposure level, the subject will be provided instructions on dose adjustment of KDT501. Dose adjustments will be administered at 800mg for 10 consecutive days, determined at day 11; followed by 1,000mg for 8 consecutive days if determined at day 21. Receives: Drug: KDT501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the 2 hour oral glucose tolerance test (OGTT) at day 28.
The change in serum glucose 2 hours following the administration of 75gm of oral glucose (2 hour oral glucose tolerance test (OGTT)) will be calculated as the difference in 2 hour OGTT at Day 28 (±2 days) vs. baseline.
Measured: 28 days (± 2 days)
Secondary outcomes (5)
Change in Resting Metabolic Rate (RMR)
The change in RMR will be calculated as the difference in RMR at Day 27 (±4 days) vs. baseline.
Measured: 27 days (±4 days)
Change in Lipid Tolerance Test
The change in lipid tolerance test parameters will be calculated as the difference at Day 27 (±4 days) vs. baseline.
Measured: 27 days (±4 days)
Change in HbA1c, fructosamine, and glycated albumin
The change in each of these assay results will be calculated as the difference at Day 27 (±4 days) vs. baseline.
Measured: 27 days (±4 days)
Change in Fasting Plasma Glucose
The change in fasting plasma glucose will be calculated as the difference at Day 27 (±4 days) vs. baseline.
Measured: 27 days (±4 days)
Change in Insulin Sensitivity Based on Euglycemic Clamp Study
The change in insulin sensitivity will be calculated as the difference at Day 27 (±4 days) vs. baseline.
Measured: 27 days (±4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- KinDex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor
- Investigators
- Philip Kern, MD, Principal investigator, University of Kentucky's Center for Clinical and Translational Science (CCTS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444910
- Sponsor's protocol ID
- 8265426
- Other IDs
- Product IND Number: 113,652
- Status last verified
- Oct 2017
- First submitted
- 7 May 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Finlin BS, Zhu B, Kok BP, Godio C, Westgate PM, Grayson N, Sims R, Bland JS, Saez E, Kern PA. The Influence of a KDT501, a Novel Isohumulone, on Adipocyte Function in Humans. Front Endocrinol (Lausanne). 2017 Sep 29;8:255. doi: 10.3389/fendo.2017.00255. eCollection 2017.
PubMed 29033896
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of KDT501 on Metabolic Features in Insulin Resistant Subjects
- ClinicalTrials.gov ID
- NCT02444910
- Acronym / sponsor ID
- 8265426
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- KDT501, Diabetes, Diabetes Mellitus, Type 2, KinDex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- KinDex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Kentucky
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
KDT501 is an orally administered product designed to help control impaired glucose and insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin sensitivity and glucose regulation as well as reduce proinflammatory signals. These properties combined with antihyperglycemic activity and modest, partial agonist effect of KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an atypical and pleiotropic mechanism of action for KDT501.
Following providing informed consent, potential subjects will undergo screening procedures to ensure that they meet all inclusion and exclusion criteria. Following registration on study, subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies, one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in registered subjects will be performed within 7 days prior to initiating therapy. On the first day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic, followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects will return to the clinic for PK studies, as noted below. Treatment in all subjects will end on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7 and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KDT501 | Experimental | Drug: KDT501Experimental drug, KDT501, is administered at 600mg for 10 consecutive days. On days 11 and 21 (+/- 1 day), based on the KDT501 drug exposure level, the subject will be provided instructions on dose adjustment of KDT501. Dose adjustments will be administered at 800mg for 10 consecutive days, determined at day 11; followed by 1,000mg for 8 consecutive days if determined at day 21. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Written informed consent obtained prior to the initiation of study procedures
- Age is 40-70 years
- Diagnosis IGT, IFG, or metabolic syndrome
- Prior therapy for IGT and IFG may include diet alone
- HbA1c <7.0% within 28 days of registration
Key exclusion criteria (20 listed)
- Prior or current history of T2DM
- Type 1 diabetes
- Subjects with IGT or IFG who have hypoglycemic unawareness and/or recurrent severe hypoglycemia
- NYHA CHF Class 2-4
- Any significant, active pulmonary disorder including FEV1 <60% predicted based on outpatient spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDT501600mg twice daily, Oral, for 10days; then 800mg twice daily, Oral, for 10 days; then 1,000mg twice daily, Oral, for 8 days. | Drug | KDT501 |
Primary outcome
Change from baseline of the 2 hour oral glucose tolerance test (OGTT) at day 28.
Time frame: 28 days (± 2 days)
The change in serum glucose 2 hours following the administration of 75gm of oral glucose (2 hour oral glucose tolerance test (OGTT)) will be calculated as the difference in 2 hour OGTT at Day 28 (±2 days) vs. baseline.
5 secondary outcomes
Change in Resting Metabolic Rate (RMR)
Time frame: 27 days (±4 days)
Change in Lipid Tolerance Test
Time frame: 27 days (±4 days)
Change in HbA1c, fructosamine, and glycated albumin
Time frame: 27 days (±4 days)
Change in Fasting Plasma Glucose
Time frame: 27 days (±4 days)
Change in Insulin Sensitivity Based on Euglycemic Clamp Study
Time frame: 27 days (±4 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 29033896Finlin BS, Zhu B, Kok BP, Godio C, Westgate PM, Grayson N, Sims R, Bland JS, Saez E, Kern PA. The Influence of a KDT501, a Novel Isohumulone, on Adipocyte Function in Humans. Front Endocrinol (Lausanne). 2017 Sep 29;8:255. doi: 10.3389/fendo.2017.00255. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Kern, MD principal investigator
University of Kentucky's Center for Clinical and Translational Science (CCTS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KDT501 in people with Diabetes Mellitus, Type 2, run by KinDex Pharmaceuticals, Inc. at 1 site 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 22 inclusion and 20 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Change from baseline of the 2 hour oral glucose tolerance test (OGTT) at day 28. (time frame: 28 days (± 2 days)). 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 NCT02444910, which also lists 1 linked publication.
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 20 Oct 2017.