Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo for Active; Drug: JTT-851; Drug: Placebo for comparator; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699737

AT851-U-12-002

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Full description

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Enrollment: 325 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females with type 2 diabetes, 18-70 years of age at Visit 1
• Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
• Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
• Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1

Exclusion criteria

• Females who are pregnant or breast-feeding
• Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
• Acute coronary syndrome or uncontrolled hypertension
• Does not meet all diet or previous/concomitant medication restriction criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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325 participants in 5 patient groups, including a placebo group

JTT-851 Dose 1

Experimental group

Description:

JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Treatment:

Drug: JTT-851

Drug: Placebo for comparator

JTT-851 Dose 2

Experimental group

Description:

JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Treatment:

Drug: JTT-851

Drug: Placebo for comparator

JTT-851 Dose 3

Experimental group

Description:

JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks

Treatment:

Drug: JTT-851

Drug: Placebo for comparator

Glimepiride Dose 1

Active Comparator group

Description:

Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks

Treatment:

Drug: Glimepiride

Drug: Placebo for Active

Placebo active & Placebo comparator

Placebo Comparator group

Description:

Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks

Treatment:

Drug: Placebo for comparator

Drug: Placebo for Active