Back to resultsStudy to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JTT-662
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring JTT-662, Diabetes, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
- Currently treated with a stable oral dose of metformin for at least 12 weeks prior to the Screening Visit
- 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)
- Must be willing to wear a continuous glucose monitor (CGM) device
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)
Sites / Locations
- Qps-Mra, Llc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
JTT-662 5 mg
JTT-662 10 mg
JTT-662 20 mg
Placebo
Arm Description
JTT-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 orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
Placebo orally once daily from Day -1 to Day 28
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04465877
Brief Title
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
February 17, 2021 (Actual)
Study Completion Date
February 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
JTT-662, Diabetes, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JTT-662 5 mg
Arm Type
Experimental
Arm Description
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
Arm Title
JTT-662 10 mg
Arm Type
Experimental
Arm Description
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
Arm Title
JTT-662 20 mg
Arm Type
Experimental
Arm Description
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally once daily from Day -1 to Day 28
Intervention Type
Drug
Intervention Name(s)
JTT-662
Intervention Description
Active drug tablets containing JTT-662
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matching in appearance to the active drug tablets
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment-emergent Adverse Events
Description
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.
Time Frame
6 Weeks (from Day -1 to the follow-up visit on Day 42)
Title
Number of Stools and Type of Stools Based on Bristol Stool Chart
Description
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.
Time Frame
7 Weeks (from Day -6 to the follow-up visit on Day 42)
Title
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Description
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.
Time Frame
28 Days
Title
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Description
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.
Time Frame
Days 1, 14 and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Qps-Mra, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
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