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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Placebo | Placebo Comparator | Placebo orally once daily from Day -1 to Day 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTT-662 | Drug | Active drug tablets containing JTT-662 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | Miami | Florida | 33143 | United States |
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Following informed consent signing, screening procedures to confirm eligibility were performed.
All subjects received a single dose of placebo on Day -1 (Placebo Run-in Period) followed by JTT-662 or placebo once-daily (QD) for 28 consecutive days (Day 1 through Day 28).
Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Placebo | Placebo orally once daily from Day -1 to Day 28 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug. | Posted | Count of Participants | Participants | 6 Weeks (from Day -1 to the follow-up visit on Day 42) |
|
Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kazuhiro Okamiya | Akros Pharma Inc. | 609-919-6123 | okamiya@akrospharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2021 | Feb 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2021 | Feb 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo | Drug | Placebo tablets matching in appearance to the active drug tablets |
|
| Days 1, 14 and 28 |
| BG002 | 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 |
| BG003 | Placebo | Placebo orally once daily from Day -1 to Day 28 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
| OG002 | 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 |
| OG003 | Placebo | Placebo orally once daily from Day -1 to Day 28 |
| OG004 | Placebo Run-in | Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1 |
|
|
| Primary | 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. | Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug. | Posted | Number | Number of stools | 7 Weeks (from Day -6 to the follow-up visit on Day 42) |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 28 Days |
|
|
|
| Primary | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | mg*hr/dL | Days 1, 14 and 28 |
|
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| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | 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 | 0 | 9 | 0 | 9 | 7 | 9 |
| EG002 | 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 | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Placebo | Placebo orally once daily from Day -1 to Day 28 | 0 | 9 | 0 | 9 | 6 | 9 |
| EG004 | Placebo Run-in | Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1 | 0 | 37 | 0 | 37 | 3 | 37 |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
The sponsor can review results communications at least 60 days prior to public release. The sponsor will have a review period of 60 days and can embargo communications regarding trial results for an additional period of 60 days from the end of sponsor review period. The sponsor may require removal of any and all confidential information (other than study results) in the communication.
| Type 1 |
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| Type 2 |
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| Type 3 |
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| Type 4 |
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| Type 5 |
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| Type 6 |
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| Type 7 |
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| Day 7 |
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| Day 10 |
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| Day 14 |
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| Day 15 |
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| Day 21 |
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| Day 28 |
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| Day 14 |
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| Day 28 |
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| Mixed Models Analysis |
| 0.995 |
| Mean Difference (Final Values) |
| 0.33 |
| 2-Sided |
| 95 |
| -105.41 |
| 106.07 |
| Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28 | Mixed Models Analysis | 0.366 | Mean Difference (Final Values) | -59.35 | 2-Sided | 95 | -191.15 | 72.45 | Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1 | Mixed Models Analysis | 0.016 | Mean Difference (Final Values) | -100.02 | 2-Sided | 95 | -179.96 | -20.08 | Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14 | Mixed Models Analysis | 0.014 | Mean Difference (Final Values) | -137.85 | 2-Sided | 95 | -245.28 | -30.43 | Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28 | Mixed Models Analysis | 0.001 | Mean Difference (Final Values) | -229.04 | 2-Sided | 95 | -362.17 | -95.91 | Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1 | Mixed Models Analysis | 0.025 | Mean Difference (Final Values) | -89.98 | 2-Sided | 95 | -167.62 | -12.33 | Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14 | Mixed Models Analysis | <0.001 | Mean Difference (Final Values) | -222.02 | 2-Sided | 95 | -326.54 | -117.51 | Superiority |
| Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28 | Mixed Models Analysis | <0.001 | Mean Difference (Final Values) | -248.82 | 2-Sided | 95 | -379.35 | -118.28 | Superiority |