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

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: JTT-662; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04465877

AT662-U-20-003

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 4 patient groups, including a placebo group

JTT-662 5 mg

Experimental group

Description:

JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1

Treatment:

Drug: JTT-662

JTT-662 10 mg

Experimental group

Description:

JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1

Treatment:

Drug: JTT-662

JTT-662 20 mg

Experimental group

Description:

JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1

Treatment:

Drug: JTT-662

Placebo

Placebo Comparator group

Description:

Placebo orally once daily from Day -1 to Day 28

Treatment:

Drug: Placebo