- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465877
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
April 28, 2022 updated by: Akros Pharma Inc.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 1
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
-
-
Florida
-
Miami, Florida, United States, 33143
- Qps-Mra, Llc
-
-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JTT-662 5 mg
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Active drug tablets containing JTT-662
|
Experimental: JTT-662 10 mg
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Active drug tablets containing JTT-662
|
Experimental: JTT-662 20 mg
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Active drug tablets containing JTT-662
|
Placebo Comparator: Placebo
Placebo orally once daily from Day -1 to Day 28
|
Placebo tablets matching in appearance to the active drug tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
28 Days
|
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.
|
Days 1, 14 and 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 15, 2020
Primary Completion (Actual)
February 17, 2021
Study Completion (Actual)
February 17, 2021
Study Registration Dates
First Submitted
July 1, 2020
First Submitted That Met QC Criteria
July 9, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT662-U-20-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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