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

Sponsor

Akros Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04465877

Collaborator

(none)

Enrollment

Location

Arms

8.1

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: JTT-662 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 15, 2020

Actual Primary Completion Date :

Feb 17, 2021

Actual Study Completion Date :

Feb 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JTT-662 Dose 1 JTT-662 Tablets Dose 1 by mouth once daily from Day 1 to Day 28	Drug: JTT-662 Active drug tablets containing JTT-662
Experimental: JTT-662 Dose 2 JTT-662 Tablets Dose 2 by mouth once daily from Day 1 to Day 28	Drug: JTT-662 Active drug tablets containing JTT-662
Experimental: JTT-662 Dose 3 JTT-662 Tablets Dose 3 by mouth once daily from Day 1 to Day 28	Drug: JTT-662 Active drug tablets containing JTT-662
Placebo Comparator: Placebo Placebo Tablets by mouth once daily from Day 1 to Day 28	Drug: Placebo Placebo tablets matching in appearance to the active drug tablets

Outcome Measures

Primary Outcome Measures

Change in postprandial glucose (PPG) area under the observed effect-time curve from the start of breakfast until the 4-hour time point (AUEC0-4) compared to placebo [Days 1, 14 and 28]
JTT-662 maximum plasma concentrations [Days 1, 14 and 28]
JTT-662 trough plasma concentrations [6 Weeks]
Number of adverse events [6 Weeks]
Measurement of blood pressure [6 Weeks]
Measurement of heart rate [6 Weeks]
Measurement of body temperature [6 Weeks]
Stool diary to assess date, time and type of stool for each stool during the study [6 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)