Diabetes Mellitus, Type 2Phase 1NCT04465877

Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes

A Phase 1 study testing JTT-662 in people with Diabetes Mellitus, Type 2, run by Shionogi Inc. at 1 site 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 evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: JTT-662
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2020to 17 Feb 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)

Who cannot join

Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
Known medical history or presence of diabetic complications
Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
Have impaired renal function (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2)

Trial locations and contacts

1 site in 1 country.

United States1 site

Qps-Mra, Llc
Miami, Florida, 33143

Other trials in United States

About this study

Official title: Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy

Conditions: Diabetes Mellitus, Type 2
Being tested: JTT-662, Placebo
Keywords: JTT-662, Diabetes, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
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.

JTT-662Drug
Active drug tablets containing JTT-662
PlaceboDrug
Placebo tablets matching in appearance to the active drug tablets

Study groups in NCT04465877
Study group	Role	What they receive
JTT-662 5 mg	Experimental	JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1 Receives: Drug: JTT-662
JTT-662 10 mg	Experimental	JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1 Receives: Drug: JTT-662
JTT-662 20 mg	Experimental	JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1 Receives: Drug: JTT-662
Placebo	Placebo comparator	Placebo orally once daily from Day -1 to Day 28 Receives: Drug: Placebo

What is being measured

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

Number of Subjects With Treatment-emergent Adverse Events
Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
Measured: 6 Weeks (from Day -1 to the follow-up visit on Day 42)
Number of Stools and Type of Stools Based on Bristol Stool Chart
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.
Measured: 7 Weeks (from Day -6 to the follow-up visit on Day 42)
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.
Measured: 28 Days
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.
Measured: Days 1, 14 and 28

Timeline

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

15 Jun 202017 Feb 2021

First posted10 Jul 2020
Study start15 Jun 2020
Primary completion17 Feb 2021
Study completion17 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04465877
Sponsor's protocol ID: AT662-U-20-003
Status last verified: Apr 2022
First submitted: 1 Jul 2020
Last updated: 27 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy
ClinicalTrials.gov ID: NCT04465877
Acronym / sponsor ID: AT662-U-20-003
Conditions: Diabetes Mellitus, Type 2
Keywords: JTT-662, Diabetes, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Shionogi Inc.Industry (pharma, biotech, devices)
Study start: 15 Jun 2020 (actual)
Primary completion: 17 Feb 2021 (actual)
Study completion: 17 Feb 2021 (actual)
First posted: 10 Jul 2020 (actual)
Results: Posted 27 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
JTT-662 5 mg	Experimental	Drug: JTT-662JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
JTT-662 10 mg	Experimental	Drug: JTT-662JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
JTT-662 20 mg	Experimental	Drug: JTT-662JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
Placebo	Placebo comparator	Drug: PlaceboPlacebo orally once daily from Day -1 to Day 28

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)

Key exclusion criteria (5 listed)

Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
Known medical history or presence of diabetic complications
Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
Have impaired renal function (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2)

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
JTT-662Active drug tablets containing JTT-662	Drug	JTT-662 10 mg, JTT-662 20 mg, JTT-662 5 mg
PlaceboPlacebo tablets matching in appearance to the active drug tablets	Drug	Placebo

Primary outcome

Number of Subjects With Treatment-emergent Adverse Events
Time frame: 6 Weeks (from Day -1 to the follow-up visit on Day 42)
Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
Number of Stools and Type of Stools Based on Bristol Stool Chart
Time frame: 7 Weeks (from Day -6 to the follow-up visit on Day 42)
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Time frame: 28 Days
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Time frame: Days 1, 14 and 28
Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.

Results and safety

Results posted to the registry on 27 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JTT-662 5 mg	9	9
JTT-662 10 mg	9	9
JTT-662 20 mg	10	9
Placebo	9	9

Primary outcome: Number of Subjects With Treatment-emergent Adverse Events

Time frame: 6 Weeks (from Day -1 to the follow-up visit on Day 42). Count of participants. Unit: Participants

Measure	JTT-662 5 mg n = 9	JTT-662 10 mg n = 9	JTT-662 20 mg n = 10	Placebo n = 9	Placebo Run-in n = 37
Number of subjects with TEAEs	4	7	10	6	3
Number of subjects with no TEAEs	5	2	0	3	34

Population analysed: Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.

Primary outcome: Number of Stools and Type of Stools Based on Bristol Stool Chart

Time frame: 7 Weeks (from Day -6 to the follow-up visit on Day 42). Number. Unit: Number of stools

Measure	JTT-662 5 mg n = 9	JTT-662 10 mg n = 9	JTT-662 20 mg n = 10	Placebo n = 9
Total Number of Stools	491	550	815	599
Type 1	15	3	9	4
Type 2	31	12	11	17
Type 3	41	21	18	102
Type 4	226	173	119	329
Type 5	63	117	106	97
Type 6	73	94	242	25
Type 7	42	130	310	25

Population analysed: Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.

Primary outcome: Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28

Time frame: 28 Days. Mean (Standard Deviation). Unit: ng/mL

Measure	JTT-662 5 mg n = 9	JTT-662 10 mg n = 9	JTT-662 20 mg n = 10
Day 1	60.2 (14.4)	124 (36.0)	231 (61.9)
Day 7	209 (61.5)	518 (155)	845 (359)
Day 10	235 (64.3)	629 (181)	959 (449)
Day 14	257 (97.3)	703 (224)	1130 (502)
Day 15	266 (83.7)	689 (209)	1140 (475)
Day 21	281 (100)	787 (237)	1180 (665)
Day 28	292 (103)	786 (326)	1190 (583)

Population analysed: PK Population consists of subjects randomized to JTT-662 treatment groups who received at least one dose of JTT-662 and had available PK data. The number of subjects on Days 21 and 28 is only 27 since 1 subject in the JTT-662 20 mg group discontinued the study on Day 19.

Primary outcome: Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28

Time frame: Days 1, 14 and 28. Least squares mean (90% Confidence Interval). Unit: mg*hr/dL

Measure	JTT-662 5 mg n = 9	JTT-662 10 mg n = 9	JTT-662 20 mg n = 10	Placebo n = 9
Day 1	-0.34 (-55.64 to 54.96)	-98.24 (-153.78 to -42.69)	-88.19 (-140.71 to -35.67)	1.78 (-54.00 to 57.57)
Day 14	-31.22 (-106.31 to 43.88)	-169.40 (-244.67 to -94.13)	-253.57 (-324.85 to -182.29)	-31.55 (-106.99 to 43.89)
Day 28	-61.17 (-154.63 to 32.28)	-230.87 (-324.46 to -137.28)	-250.64 (-340.71 to -160.58)	-1.83 (-95.55 to 91.90)

JTT-662 5 mg vs Placebo: Mean Difference (Final Values): -2.12 (95% CI -79.67 to 75.42), p = 0.956, Mixed Models Analysis
JTT-662 5 mg vs Placebo: Mean Difference (Final Values): 0.33 (95% CI -105.41 to 106.07), p = 0.995, Mixed Models Analysis
JTT-662 5 mg vs Placebo: Mean Difference (Final Values): -59.35 (95% CI -191.15 to 72.45), p = 0.366, Mixed Models Analysis

Population analysed: PD Population consists of subjects who were randomly assigned to treatment, received at least one dose of JTT-662 or placebo starting on Day 1 and had evaluable PD data. For the JTT-662 20 mg group, number of participants analyzed on Day 28 is 9 since 1 subject did not complete the study.

Adverse events

Time frame: Up to 6 weeks (from Day -1 to the follow-up visit on Day 42). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JTT-662 5 mg	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
JTT-662 10 mg	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
JTT-662 20 mg	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Placebo	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Placebo Run-in	0 of 37 (0%)	3 of 37 (8.1%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JTT-662 in people with Diabetes Mellitus, Type 2, run by Shionogi 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 5 inclusion and 5 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 27 Jan 2023. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 With Treatment-emergent Adverse Events (time frame: 6 Weeks (from Day -1 to the follow-up visit on Day 42)). The study lists 4 primary outcomes in all. 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 NCT04465877.

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 27 Jan 2023.