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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-02-17

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

JTT-662

Intervention Type DRUG

Active drug tablets containing JTT-662

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

Group Type EXPERIMENTAL

JTT-662

Intervention Type DRUG

Active drug tablets containing JTT-662

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

Group Type EXPERIMENTAL

JTT-662

Intervention Type DRUG

Active drug tablets containing JTT-662

Placebo

Placebo orally once daily from Day -1 to Day 28

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets matching in appearance to the active drug tablets

Interventions

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JTT-662

Active drug tablets containing JTT-662

Intervention Type DRUG

Placebo

Placebo tablets matching in appearance to the active drug tablets

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No