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Clinical Trial Details

Trial ID: L7258
Source ID: NCT04465877
Associated Drug: Jtt-662
Title: Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04465877/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: JTT-662|DRUG: Placebo
Outcome Measures: 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., 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., Days 1, 14 and 28 |
Sponsor/Collaborators: Sponsor: Akros Pharma Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 37
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-06-15
Completion Date: 2021-02-17
Results First Posted: 2023-01-27
Last Update Posted: 2023-01-27
Locations: Qps-Mra, Llc, Miami, Florida, 33143, United States
URL: https://clinicaltrials.gov/show/NCT04465877